A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (AMETHYST)

April 22, 2026 updated by: Biogen

A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue.

The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms and signs of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).

The main questions researchers want to answer are:

  • How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment?
  • How many participants have their skin disease activity go down by at least 70% as measured by CLASI?

Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires.

The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows:

  • After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine.
  • Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks.
  • The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
  • This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin.
  • During the 2nd treatment period, all participants will receive litifilimab for 28 weeks.
  • After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks.
  • The total study duration for participants will be up to 80 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Litifilimab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting blood dendritic cell antigen 2. It is an inhibitory receptor expressed on the surface of human plasmacytoid dendritic cell (pDCs) and is being investigated for the potential treatment of systemic lupus erythematosus and cutaneous lupus erythematosus. The primary objectives of the study are to evaluate the efficacy of litifilimab compared with placebo in reducing skin disease activity measured by the CLA-IGA-R score [Parts A] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of litifilimab in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of litifilimab in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of litifilimab [Parts A and B].

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1900AXI
        • Recruiting
        • Hospital Italiano de La Plata
        • Principal Investigator:
          • Sebastian Juan Magri
        • Contact:
          • Phone Number: 5492215928029
      • Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
        • Recruiting
        • Clinica Adventista Belgrano
        • Principal Investigator:
          • Federico Javier Ariel
        • Contact:
          • Phone Number: 541145445522
      • Ciudad Autonoma Buenos Aires, Argentina, C1417
        • Recruiting
        • Centro Privado de Medicina Familiar - Mind Out Research
        • Contact:
          • Phone Number: 5491149273479
        • Principal Investigator:
          • Leonardo Naftal
      • Ciudad Autonoma Buenos Aires, Argentina, C1199ABB
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
          • Phone Number: +541148274281
        • Principal Investigator:
          • Luis Daniel Mazzuoccolo
      • Mendoza, Argentina, M5500
        • Recruiting
        • Instituto de Reumatologia
        • Principal Investigator:
          • Alfredo Borgia
        • Contact:
          • Phone Number: 5492615440980
      • San Juan, Argentina, 5400
        • Recruiting
        • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
        • Principal Investigator:
          • Jose Luis Cristian Moreno
        • Contact:
          • Phone Number: 5492645655194
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1056ABI
        • Completed
        • Cinme - Centro de Investigaciones Metabolicas
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Recruiting
        • Centro de Investigaciones Medicas Mar del Plata
        • Principal Investigator:
          • Gladys Alicia Testa
        • Contact:
          • Phone Number: 5492235603218
      • Quilmes, Buenos Aires, Argentina, B1878GEG
        • Recruiting
        • Instituto de Investigaciones Clinicas Quilmes
        • Principal Investigator:
          • Jose Luis Velasco Zamora
        • Contact:
          • Phone Number: 5491135804733
      • San Miguel, Buenos Aires, Argentina, 1663
        • Recruiting
        • Centro de Investigaciones San Miguel
        • Contact:
          • Phone Number: +5491153342038
        • Principal Investigator:
          • Adrian Alejandro Schejtman
    • Ciudad Autonoma Buenos Aires
      • Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, C1406AGA
        • Recruiting
        • APRILLUS Asistencia E Investigacion
        • Principal Investigator:
          • Pablo Alejandro Mannucci Walter
        • Contact:
          • Phone Number: 541567415099
      • Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, C1426ABO
        • Recruiting
        • Fundación Respirar
        • Contact:
          • Phone Number: 541167063598
        • Principal Investigator:
          • ALEJANDRO ARROYO
    • Mendoza Province
      • Villa Nueva, Mendoza Province, Argentina, CP 5519
        • Recruiting
        • Consultorio Alto Dorrego
        • Contact:
          • Phone Number: +5492615988653
        • Principal Investigator:
          • Matias Manuel Benavente
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000PBJ
        • Recruiting
        • Instituto CAICI
        • Contact:
          • Phone Number: 543413000000
        • Principal Investigator:
          • Carolina Irma Dieguez
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • Recruiting
        • Centro de Investigaciones Médicas Tucumán
        • Principal Investigator:
          • Walter Javier Spindler
        • Contact:
          • Phone Number: 543814200180
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Recruiting
        • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
        • Contact:
          • Phone Number: 543814304423
        • Principal Investigator:
          • Francisco Colombres
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000ICL
        • Recruiting
        • Investigaciones Clinicas Tucuman
        • Principal Investigator:
          • Veronica Ines Bellomio
        • Contact:
          • Phone Number: 5493815932070
  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques universitaires Saint-Luc
        • Contact:
          • Phone Number: +3227641472
        • Principal Investigator:
          • Pierre Dominique Ghislain
      • Ghent, Belgium, 9000
        • Recruiting
        • Universitair Ziekenhuis Gent
        • Contact:
          • Phone Number: +3293322287
        • Principal Investigator:
          • Reinhart Speeckaert
      • Liège, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Universitaire de Liège
        • Contact:
          • Phone Number: +3243667232
        • Principal Investigator:
          • Arjen Fokko Nikkels
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 03000
        • Recruiting
        • UZ Leuven
        • Contact:
          • Phone Number: +3216337950
        • Principal Investigator:
          • Petra De Haes
  • Brazil
      • São Paulo, Brazil, 04037-030
        • Recruiting
        • RDSS Ricardo Diaz Scientific Solution
        • Principal Investigator:
          • Roberta Queiroz Graumam
        • Contact:
          • Phone Number: +5521997994412
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-370
        • Recruiting
        • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
        • Contact:
          • Phone Number: 5585991711566
        • Principal Investigator:
          • Vanessa Beatriz de Vasconcelos Marques
      • Fortaleza, Ceará, Brazil, 60125-000
        • Recruiting
        • Integrare Terapêutica
        • Contact:
          • Phone Number: +558530446556
        • Principal Investigator:
          • Max Victor Carioca de Freitas
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055-450
        • Completed
        • CEDOES - Diagnóstico e Pesquisa
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40150-150
        • Recruiting
        • Clínica SER da Bahia
        • Principal Investigator:
          • Mittermayer Barreto Santiago
        • Contact:
          • Phone Number: 5571990000000
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • Recruiting
        • L2IP - Instituto de Pesquisas Clínicas Ltda.
        • Principal Investigator:
          • Eduardo Freire Vasconcellos
        • Contact:
          • Phone Number: 556134454300
    • Mato Grosso
      • Santo Ângelo, Mato Grosso, Brazil, 78020-500
        • Recruiting
        • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
        • Principal Investigator:
          • Luiz Sergio Guedes Barbosa
        • Contact:
          • Phone Number: 5565999814014
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Recruiting
        • Santa Casa de Misericordia de Belo Horizonte
        • Principal Investigator:
          • Claudia Lopes Santoro Neiva
        • Contact:
          • Phone Number: 553198651041
      • Belo Horizonte, Minas Gerais, Brazil, 30180-065
        • Recruiting
        • Clinica Pulsus
        • Contact:
          • Phone Number: +553134099255
        • Principal Investigator:
          • Fabiana de Miranda Moura dos Santos
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Recruiting
        • CMiP - Centro Mineiro de Pesquisa
        • Contact:
          • Phone Number: 553233000000
        • Principal Investigator:
          • Silviane Vassalo
    • Rio Do Janeiro
      • Rio de Janeiro, Rio Do Janeiro, Brazil, 20241-180
        • Recruiting
        • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
        • Contact:
          • Phone Number: 552125277979
        • Principal Investigator:
          • Jaqueline Barbeito de Vasconcellos
      • Rio de Janeiro, Rio Do Janeiro, Brazil, 22470-220
        • Recruiting
        • IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda
        • Contact:
          • Phone Number: 552125000000
        • Principal Investigator:
          • Luna Azulay Abulafia
    • Rio Grande do Sul
      • Lajeado, Rio Grande do Sul, Brazil, 95900-000
        • Recruiting
        • Hospital Bruno Born
        • Principal Investigator:
          • Jussara Marilu Bohn
        • Contact:
          • Phone Number: 555137147500
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:
          • Phone Number: 555133000000
        • Principal Investigator:
          • Odirlei Andre Monticielo
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560032
        • Recruiting
        • Hospital Moinhos de Vento
        • Principal Investigator:
          • Tamara Mucenic
        • Contact:
          • Phone Number: 51997393212
      • Porto Alegre, Rio Grande do Sul, Brazil, 90430001
        • Recruiting
        • Nucleo de Pesquisa Clinica do Rio Grande do Sul
        • Contact:
          • Phone Number: 555137796400
        • Principal Investigator:
          • Cecilia Viola Varella da Costa
      • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
        • Recruiting
        • LMK Serviços Médicos S/S Ltda
        • Principal Investigator:
          • Mauro Waldemar Keiserman
        • Contact:
          • Phone Number: 555133205057
    • Rondônia
      • Porto Velho, Rondônia, Brazil, 76804366
        • Recruiting
        • IPES - Instituto de Pesquisa e Educação em Saúde
        • Contact:
          • Phone Number: +5569993787257
        • Principal Investigator:
          • Samila Alves Da Silva Paschoal
    • São Paulo
      • São Bernardo do Campo, São Paulo, Brazil, 09715-090
        • Recruiting
        • CEMEC - Centro Multidisciplinar de Estudos Clínicos
        • Contact:
          • Phone Number: 551149304243
        • Principal Investigator:
          • Paulo Ricardo Criado
      • São Paulo, São Paulo, Brazil, 04266-010
        • Recruiting
        • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
        • Contact:
          • Phone Number: 551122713450
        • Principal Investigator:
          • Flora Maria D'Andrea Marcolino
      • Valinhos, São Paulo, Brazil, 13271-130
        • Recruiting
        • A2Z Clinical Centro Avancado de Pesquisa Clinica
        • Principal Investigator:
          • Alisson Aliel Vigano Pugliesi
        • Contact:
          • Phone Number: +5511993365287
  • Bulgaria
      • Haskovo, Bulgaria, 6300
        • Recruiting
        • DCC 'Sveti Georgi' EOOD
        • Principal Investigator:
          • Irida Vasileva
        • Contact:
          • Phone Number: +359888325384
      • Pleven, Bulgaria, 5800
        • Completed
        • UMHAT 'Dr. Georgi Stranski', EAD
      • Pleven, Bulgaria, 5800
        • Completed
        • Medical Center Medconsult Pleven OOD
      • Rousse, Bulgaria, 7002
        • Completed
        • DCC 1 - Ruse, EOOD
      • Sofia, Bulgaria, 1431
        • Recruiting
        • Dcc 'Alexandrovska', Eood
        • Principal Investigator:
          • Petyo Brezoev
        • Contact:
          • Phone Number: 359888208421
      • Sofia, Bulgaria, 1463
        • Completed
        • DCC Focus 5 - MEOH OOD
      • Sofia, Bulgaria, 1606
        • Completed
        • Military Medical Academy - MHAT - Sofia
      • Sofia, Bulgaria, 1407
        • Recruiting
        • Ambulatory For Specialized Medical Help - Skin and Venereal Diseases
        • Contact:
          • Phone Number: +359888207206
        • Principal Investigator:
          • Ivan Botev
    • Gabrovo
      • Sevlievo, Gabrovo, Bulgaria, 5400
        • Recruiting
        • DCC-1-Sevlievo EOOD
        • Principal Investigator:
          • Dimitar Nikolov
        • Contact:
          • Phone Number: +359893028511
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2W 4X9
        • Recruiting
        • Laser Rejuvenation Clinics, Inc.
        • Principal Investigator:
          • Paul Kuzel
        • Contact:
          • Phone Number: 4032866888
      • Edmonton, Alberta, Canada, T5J 3S9
        • Recruiting
        • Laster Rejuvenation Clinics Edmonton D.T. Inc.
        • Contact:
          • Phone Number: 7804251212
        • Principal Investigator:
          • Maninder Longowal
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3C 1X3
        • Completed
        • Medicor Research Inc
      • Ottawa, Ontario, Canada, K2C 3N2
        • Completed
        • Dermatology Ottawa Research Centre
    • Quebec
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • Recruiting
        • DIEX Recherche Sherbrooke Inc.
        • Contact:
          • Phone Number: 8193462887
        • Principal Investigator:
          • Daniel Minier
  • Chile
      • Las Condes, Chile, 7580206
        • Recruiting
        • Centro Medico SkinMed
        • Contact:
          • Phone Number: 56232746600
        • Principal Investigator:
          • Juan Walter Gubelin Harcha
      • Santiago, Chile, 7500710
        • Recruiting
        • Biomedica Research Group
        • Principal Investigator:
          • Elizabeth Jean Moreno Goio
        • Contact:
          • Phone Number: 56992323955
      • Santiago, Chile, 8331143
        • Recruiting
        • CeCim Biocinetic
        • Contact:
          • Phone Number: 56226965804
        • Principal Investigator:
          • Darwin Yañez Pizarro
      • Santiago, Chile, 66901
        • Recruiting
        • Dermacross
        • Contact:
          • Phone Number: 56229540251
        • Principal Investigator:
          • Claudia Paz De La Cruz
      • Santiago, Chile, 8420383
        • Recruiting
        • CIEC - Centro Internacional de Estudios Clínicos
        • Principal Investigator:
          • Fernando Valenzuela
        • Contact:
          • Phone Number: 56227357954
      • Valdivia, Chile, 5090000
        • Recruiting
        • Clinical Research Chile SpA.
        • Contact:
          • Phone Number: 56940601237
        • Principal Investigator:
          • Alvaro Andres San Martin Leal
      • Viña del Mar, Chile, 2520598
        • Recruiting
        • Oncocentro Apys
        • Contact:
          • Phone Number: 56322675546
        • Principal Investigator:
          • Renato Eduardo Jimenez Calabrese
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Beijing Tongren Hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
    • Guangdong
      • Dongguan, Guangdong, China, 523059
        • Recruiting
        • Dongguan People's Hospital
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Southern Medical University
      • Shenzhen, Guangdong, China, 518029
        • Recruiting
        • Shenzhen Second People's Hospital
      • Zhongshan, Guangdong, China, 528400
        • Recruiting
        • Zhongshan TCM Hospital
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510120
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    • Henan
      • Nanyang, Henan, China, 473004
        • Completed
        • Nanyang First People's Hospital
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial People's Hospital
    • Hu'nan
      • Changsha, Hu'nan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital Of Central South University
      • Changsha, Hu'nan, China, 410008
        • Recruiting
        • Xiangya Hospital of Central South University
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014010
        • Recruiting
        • The First Affiliated Hospital of Baotou Medical College
    • Jiangsu
      • Nanjing, Jiangsu, China, 210042
        • Recruiting
        • Hospital for Skin Diseases, Chinese Academy of Medical Sciences
      • Zhenjiang, Jiangsu, China, 212001
        • Completed
        • Affiliated Hospital of Jiangsu University
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
    • Shandong
      • Jinan, Shandong, China, 250012
        • Completed
        • Qilu Hospital of Shandong University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Zhongshan Hospital Fudan University
      • Shanghai, Shanghai Municipality, China, 200443
        • Recruiting
        • Shanghai Skin Disease Hospital
      • Shanghai, Shanghai Municipality, China, 200011
        • Recruiting
        • Ruijin Hospital of Shanghai Jiaotong University School of Medicine
    • Yunnan
      • Kunming, Yunnan, China, 650101
        • Recruiting
        • The Second Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital of Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • Hangzhou First People's Hospital
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
  • Colombia
      • Bogotá, Colombia, 110221
        • Recruiting
        • Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 80020
        • Recruiting
        • Centro de Investigacion Medico Asistencial S.A.S
    • Cundinamarca
      • Zipaquirá, Cundinamarca, Colombia, 250252
        • Recruiting
        • Healthy Medical Center
    • Santander Department
      • Bucaramanga, Santander Department, Colombia, 680003
        • Recruiting
        • Servimed S.A.S.
  • France
      • Paris, France, 75020
        • Recruiting
        • Hôpital Tenon
        • Contact:
          • Phone Number: 33156017221
        • Principal Investigator:
          • Francois Chasset
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 6200
        • Recruiting
        • CHU Nice - Hopital de l Archet
        • Contact:
          • Phone Number: 33492036070
        • Principal Investigator:
          • Florence Le Duff
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13385
        • Completed
        • Hôpital de la Timone
    • Calvados
      • Caen, Calvados, France, 14033
        • Recruiting
        • CHU de Caen - Hopital de la Cote de Nacre
        • Contact:
          • Phone Number: 33231272510
        • Principal Investigator:
          • Diane Kottler
    • Doubs
      • Besançon, Doubs, France, 25030
        • Recruiting
        • CHU Besancon - Hopital Jean Minjoz
        • Contact:
          • Phone Number: 33381218102
        • Principal Investigator:
          • Julie Castagna
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31059
        • Recruiting
        • Hopital Larrey
        • Contact:
          • Phone Number: 33567778135
        • Principal Investigator:
          • Cristina Bulai Livideanu
    • Hauts De Seine
      • Antony, Hauts De Seine, France, 92160
        • Completed
        • Hopital Prive d'Antony
    • Herault
      • Montpellier, Herault, France, 34295
        • Recruiting
        • Hopital Saint Eloi
        • Contact:
          • Phone Number: 33467336906
        • Principal Investigator:
          • Didier Bessis
    • Nord
      • Lille, Nord, France, 59037
        • Recruiting
        • Hopital Claude Huriez - CHU Lille
        • Contact:
          • Phone Number: +33320444193
        • Principal Investigator:
          • Delphine Staumont Salle
    • Paris
      • Cedex 10, Paris, France, 75475
        • Recruiting
        • Hôpital Saint-Louis
        • Principal Investigator:
          • Jean-David Bouaziz
        • Contact:
          • Phone Number: 33142499961
    • Rhone
      • Lyon, Rhone, France, 69003
        • Completed
        • Hopital Edouard Herriot - CHU Lyon
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité - Campus Charité Mitte
        • Contact:
          • Phone Number: 4930450518105
        • Principal Investigator:
          • Margitta Worm
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Completed
        • Universitaetsklinikum Heidelberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen
        • Principal Investigator:
          • Matthias Hahn
        • Contact:
          • Phone Number: +4970712986745
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Universitaetsklinikum Erlangen
        • Contact:
          • Phone Number: 4991318533851
        • Principal Investigator:
          • Michael Sticherling
      • Munich, Bavaria, Germany, 80802
        • Recruiting
        • Klinikum rechts der Isar der TU Muenchen
        • Contact:
          • Phone Number: +498941403177
        • Principal Investigator:
          • Danielle Rogner
      • Munich, Bavaria, Germany, 80336
        • Recruiting
        • LMU-Campus Innenstadt
        • Contact:
          • Phone Number: +498941403220
        • Principal Investigator:
          • Felix Lauffer
      • Regensburg, Bavaria, Germany, 93053
        • Recruiting
        • Universitaetsklinikum Regensburg
        • Contact:
          • Phone Number: +499419449610
        • Principal Investigator:
          • Bernadett Kurz
      • Würzburg, Bavaria, Germany, 97080
        • Recruiting
        • Universitaetsklinikum Wuerzburg
        • Contact:
          • Phone Number: +4993120126351
        • Principal Investigator:
          • Matthias Goebeler
    • Lower Saxony
      • Bad Bentheim, Lower Saxony, Germany, 48455
        • Recruiting
        • Fachklinik Bad Bentheim Dermatologie
        • Principal Investigator:
          • Athanasios Tsianakas
        • Contact:
          • Phone Number: 495922745270
      • Buxtehude, Lower Saxony, Germany, 21614
        • Recruiting
        • Elbekliniken Buxtehude GmbH
        • Contact:
          • Phone Number: 4941617036005
        • Principal Investigator:
          • Andreas Kleinheinz
      • Oldenburg, Lower Saxony, Germany, 26133
        • Recruiting
        • Klinikum Oldenburg AoeR
        • Contact:
          • Phone Number: 4944140372854
        • Principal Investigator:
          • Nikolaos Patsinakidis
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany, 52074
        • Recruiting
        • Universitaetsklinikum Aachen AOeR
        • Contact:
          • Phone Number: 492418088331
        • Principal Investigator:
          • Amir Yazdi
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Completed
        • Universitaetsklinikum Bonn AoeR
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Recruiting
        • Universitaetsklinikum Duesseldorf AoeR
        • Contact:
          • Phone Number: +492118117608
        • Principal Investigator:
          • Stephan Meller
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Recruiting
        • Universitaetsklinikum Muenster
        • Contact:
          • Phone Number: 492518356501
        • Principal Investigator:
          • Kerstin Steinbrink
    • Saxony
      • Dresden, Saxony, Germany, 1307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
        • Contact:
          • Phone Number: 493514582344
        • Principal Investigator:
          • Claudia Guenther
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 6120
        • Recruiting
        • Universitaetsklinikum Halle (Saale)
        • Principal Investigator:
          • Johannes Wohlrab
        • Contact:
          • Phone Number: 493455573933
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Completed
        • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
  • Hungary
      • Budapest, Hungary, 1085
        • Recruiting
        • Semmelweis Egyetem
        • Contact:
          • Phone Number: +36208258870
        • Principal Investigator:
          • Peter Hollo
      • Pécs, Hungary, 7632
        • Recruiting
        • Pécsi Tudományegyetem
        • Contact:
          • Phone Number: 3639161691
        • Principal Investigator:
          • Anita Hanyecz
      • Szeged, Hungary, 6720
        • Recruiting
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
        • Contact:
          • Phone Number: +3662545277
        • Principal Investigator:
          • Rolland Peter Gyulai
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
        • Contact:
          • Phone Number: 39512144847
        • Principal Investigator:
          • Michelangelo La Placa
      • Brescia, Italy, 25123
        • Recruiting
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
        • Contact:
          • Phone Number: 39303995307
        • Principal Investigator:
          • Piergiacomo Calzavara Pinton
      • Florence, Italy, 50121
        • Recruiting
        • Universita Degli Studi Di Firenze
        • Contact:
          • Phone Number: 39556939670
        • Principal Investigator:
          • Marzia Caproni
      • Genova, Italy, 16132
        • Recruiting
        • IRCCS Ospedale Policlinico San Martino
        • Contact:
          • Phone Number: 39103626430
        • Principal Investigator:
          • Emanuele Claudio Cozzani
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
        • Principal Investigator:
          • Lorenzo Dagna
        • Contact:
          • Phone Number: 39226434683
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
        • Contact:
          • Phone Number: 39255036289
        • Principal Investigator:
          • Angelo Valerio Marzano
      • Naples, Italy, 80131
        • Completed
        • Azienda Ospedaliera Universitaria Policlinico 'Federico II'
      • Roma, Italy, 137
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
          • Phone Number: 39630154798
        • Principal Investigator:
          • Clara De Simone
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 457-8510
        • Recruiting
        • Jcho Chukyo Hospital
      • Nagoya, Aichi-ken, Japan, 460-0001
        • Recruiting
        • NHO Nagoya Medical Center
      • Toyoake-shi, Aichi-ken, Japan, 470-1192
        • Recruiting
        • Fujita Health University Hospital
    • Aomori
      • Aomori, Aomori, Japan, 030-8553
        • Recruiting
        • Aomori Prefectural Central Hospital
    • Chiba
      • Urayasu-shi, Chiba, Japan, 279-0021
        • Recruiting
        • Juntendo University Urayasu Hospital
    • Fukui
      • Yoshida-gun, Fukui, Japan, 910-1193
        • Recruiting
        • University of Fukui Hospital
    • Fukuoka
      • Kitakyushu-shi, Fukuoka, Japan, 807-8556
        • Recruiting
        • Hospital of the University of Occupational and Environmental Health
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
    • Hyōgo
      • Kakogawa-shi, Hyōgo, Japan, 675-8611
        • Recruiting
        • Kakogawa Central City Hospital
      • Ono-shi, Hyōgo, Japan, 675-1392
        • Completed
        • Kita Harima Medical Center
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital
      • Yokohama, Kanagawa, Japan, 232-0024
        • Recruiting
        • Yokohama City University Medical Center
      • Yokohama, Kanagawa, Japan, 236-0004
        • Recruiting
        • Yokohama City University Hospital
      • Yokohama, Kanagawa, Japan, 245-8575
        • Recruiting
        • NHO Yokohama Medical Center
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 860-8556
        • Recruiting
        • Kumamoto University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Recruiting
        • Nagasaki University Hospital
    • Niigata
      • Niigata, Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical & Dental Hospital
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8607
        • Recruiting
        • Japanese Red Cross Okayama Hospital
    • Osaka
      • Kawachinagano-shi, Osaka, Japan, 586-8521
        • Recruiting
        • NHO Osaka Minami Medical Center
      • Osaka, Osaka, Japan, 543-8922
        • Recruiting
        • Daini Osaka Police Hospital
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Recruiting
        • Kindai University Hospital
      • Suita-shi, Osaka, Japan, 565-0871
        • Recruiting
        • Osaka University Hospital
      • Takatsuki-shi, Osaka, Japan, 569-1096
        • Recruiting
        • Takatsuki Red Cross Hospital
    • Shiga
      • Ōtsu, Shiga, Japan, 520-2192
        • Recruiting
        • Shiga University of Medical Science Hospital
    • Shimane
      • Izumo-shi, Shimane, Japan, 693-8501
        • Recruiting
        • Shimane University Hospital
    • Tokyo-To
      • Itabashi-ku, Tokyo-To, Japan, 173-8606
        • Recruiting
        • Teikyo University Hospital
      • Shinagawa-ku, Tokyo-To, Japan, 142-0054
        • Recruiting
        • Showa University East Hospital
    • Wakayama
      • Wakayama, Wakayama, Japan, 641-8510
        • Recruiting
        • Wakayama Medical University Hospital
  • Mexico
      • Aguascalientes, Mexico, 20127
        • Recruiting
        • Derma Norte del Bajio S.C.
        • Contact:
          • Phone Number: 524499143079
        • Principal Investigator:
          • Eduardo David Poletti Vazquez
      • Chihuahua City, Mexico, 31000
        • Recruiting
        • Investigacion y Biomedicina de Chihuahua, S.C.
        • Contact:
          • Phone Number: 5216141961278
        • Principal Investigator:
          • Cesar Francisco Pacheco Tena
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44959
        • Recruiting
        • Centro de investigacion medica y reumatologia
        • Principal Investigator:
          • Jorge Enrique Aguilar Arreola
        • Contact:
          • Phone Number: 523333910401
    • Mexico City
      • Mexico City, Mexico City, Mexico, 3720
        • Recruiting
        • Centro de Investigacion Clínica GRAMEL S.C
        • Contact:
          • Phone Number: 525544274848
        • Principal Investigator:
          • Carlos Tzalam Vega Nava
      • Mexico City, Mexico City, Mexico, 6700
        • Recruiting
        • Clinstile, S.A. de C.V.
        • Contact:
          • Phone Number: 525552561496
        • Principal Investigator:
          • Favio Edmundo Enriquez Sosa
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62448
        • Recruiting
        • Consultorio Privado Dr. Miguel Cortes Hernandez
        • Principal Investigator:
          • Miguel Cortes Hernandez
        • Contact:
          • Phone Number: 527773137932
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Recruiting
        • Medical Care & Research SA de CV
        • Contact:
          • Phone Number: 529993226891
        • Principal Investigator:
          • Aaron Alejandro Barrera Rodriguez
  • Peru
      • Lima, Peru, Lima 33
        • Recruiting
        • Invest Clinicas Sac Inst de Ginecologia y Reproduccion
        • Principal Investigator:
          • Julia Elena Calderon Gallegos
        • Contact:
          • Phone Number: +51980802519
      • Lima, Peru, Lima 11
        • Recruiting
        • ACQ MEDIC SAC - Centro de Investigacion Clinica Inmunoreumatologia
        • Principal Investigator:
          • Armando Calvo Quiroz
        • Contact:
          • Phone Number: +511999096916
  • Philippines
      • Cebu City, Philippines, 6000
        • Recruiting
        • Cebu Doctors University Hospital
        • Contact:
          • Phone Number: 63322536605
        • Principal Investigator:
          • Merle Y Barba
      • City of Taguig, Philippines, 1642
        • Recruiting
        • Ospital ng Makati
      • Lipa City, Philippines, 4217
        • Recruiting
        • Mary Mediatrix Medical Center
      • Manila, Philippines, 1000
        • Recruiting
        • Philippine General Hospital
      • Manila, Philippines, 1000
        • Recruiting
        • Medical Center Manila
      • Manila, Philippines, 1012
        • Recruiting
        • Jose R. Reyes Memorial Medical Center
      • Pasig, Philippines, 1605
        • Recruiting
        • The Medical City
      • Quezon City, Philippines, 1102
        • Recruiting
        • St. Luke's Medical Center
      • Quezon City, Metro Manila, Philippines, 1118
        • Recruiting
        • Far Eastern University - Dr. Nicanor Reyes Medical Foundation
      • San Fenando, La Union, Philippines, 2500
        • Recruiting
        • Ilocos Training and Regional Medical Center
      • San Fernando City, La Union, Philippines, 2500
        • Recruiting
        • Lorma Medical Center
    • Pampanga
      • Mabalacat, Pampanga, Philippines, 2023
        • Recruiting
        • The Medical City Clark
  • Poland
      • Kielce, Poland, 25-553
        • Recruiting
        • Dermedic Jacek Zdybski
        • Principal Investigator:
          • Jacek Zdybski
        • Contact:
          • Phone Number: +48601936924
      • Krakow, Poland, 31-530
        • Completed
        • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski
      • Krakow, Poland, 31-501
        • Completed
        • SPZOZ Szpital Uniwersytecki w Krakowie
      • Krakow, Poland, 31-513
        • Recruiting
        • Promed P.Lach R.Glowacki spolka jawna, Centrum Medyczne PROMED
        • Contact:
          • Phone Number: +48122954139
        • Principal Investigator:
          • Ewa Gorecka
      • Krosno, Poland, 38-400
        • Recruiting
        • MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapinski
        • Principal Investigator:
          • Anna Rajchel
        • Contact:
          • Phone Number: +48501649474
      • Lodz, Poland, 90-436
        • Recruiting
        • Dermoklinika Centrum Medyczne SC M Kierstan J Narbutt A Lesiak
        • Principal Investigator:
          • Joanna Narbutt
        • Contact:
          • Phone Number: 48692065698
      • Rzeszów, Poland, 35-055
        • Recruiting
        • Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina
        • Contact:
          • Phone Number: 48717842292
        • Principal Investigator:
          • Adam Andrzej Reich
      • Warsaw, Poland, 00-874
        • Recruiting
        • MICS Centrum Medyczne Warszawa
        • Principal Investigator:
          • Katarzyna Romanowska Prochnicka
        • Contact:
          • Phone Number: +48608552294
      • Warsaw, Poland, 02-008
        • Recruiting
        • Szpital Kliniczny Dzieciatka Jezus
        • Contact:
          • Phone Number: 48225021324
        • Principal Investigator:
          • Lidia Rudnicka
      • Warsaw, Poland, 02-962
        • Recruiting
        • Royalderm
        • Principal Investigator:
          • Witold Owczarek
        • Contact:
          • Phone Number: 48601316460
      • Wroclaw, Poland, 50-566
        • Completed
        • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Recruiting
        • Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC)
        • Contact:
          • Phone Number: 351239000000
        • Principal Investigator:
          • Margarida Goncalo
      • Lisbon, Portugal, 1998-018
        • Recruiting
        • Hospital CUF Descobertas
        • Contact:
          • Phone Number: 351210025200
        • Principal Investigator:
          • Pedro Mendes Bastos
      • Lisbon, Portugal, 1349-019
        • Recruiting
        • Hospital de Egas Moniz
        • Contact:
          • Phone Number: 351210431000
        • Principal Investigator:
          • Fernando Pimentel Dos Santos
      • Porto, Portugal, 4099-001
        • Completed
        • Centro Hospitalar Universitártio do Porto, E.P.E.
      • Viana do Castelo, Portugal, 4904-858
        • Completed
        • Unidade Local de Saúde do Alto Minho, E.P.E.
  • Puerto Rico
      • Caguas, Puerto Rico, 00727
        • Completed
        • Dr. Samuel Sanchez PSC
      • San Juan, Puerto Rico, 917
        • Recruiting
        • GCM Medical Group PSC - Hato Rey
        • Contact:
          • Phone Number: 7879362100
        • Principal Investigator:
          • Jose R Gonzalez Chavez
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11461
        • Recruiting
        • King Saud University
        • Contact:
          • Phone Number: 96614670000
        • Principal Investigator:
          • Ibrahim Ali Almaghlouth
      • Riyadh, Saudi Arabia, 11211
        • Completed
        • King Faisal Specialist Hospital & Research Center
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Clinical Center of Serbia
        • Principal Investigator:
          • Snezana Arandjelovic
        • Contact:
          • Phone Number: 381113663700
      • Belgrade, Serbia, 11000
        • Recruiting
        • Institute of Rheumatology
        • Principal Investigator:
          • Goran Radunovic
        • Contact:
          • Phone Number: 381113600801
      • Kragujevac, Serbia, 34000
        • Recruiting
        • University Clinical Center Kragujevac
        • Contact:
          • Phone Number: 381641750795
        • Principal Investigator:
          • Mirjana Veselinovic
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Clinical Center of Vojvodina
        • Contact:
          • Phone Number: 381648000000
        • Principal Investigator:
          • Ljuba Vujanovic
  • Slovakia
      • Košice, Slovakia, 4011
        • Recruiting
        • Artromac n.o.
        • Contact:
          • Phone Number: 421911900704
        • Principal Investigator:
          • Zelmira Macejova
      • Piešťany, Slovakia, 92112
        • Completed
        • Narodny ustav reumatickych chorob
  • South Korea
      • Daejeon, South Korea, 35015
        • Recruiting
        • Chungnam National University Hospital
      • Gwangju, South Korea, 61469
        • Completed
        • Chonnam National University Hospital
      • Seoul, South Korea, 4763
        • Recruiting
        • Hanyang University Seoul Hospital
      • Seoul, South Korea, 3722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 6591
        • Completed
        • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, South Korea, 15355
        • Recruiting
        • Korea University Ansan Hospital
      • Suwon, Gyeonggi-do, South Korea, 16499
        • Recruiting
        • Ajou University Hospital
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario A Coruña
        • Contact:
          • Phone Number: 34981176399
        • Principal Investigator:
          • Francisco Javier Blanco Garcia
      • Barcelona, Spain, 8003
        • Recruiting
        • Hospital del Mar
        • Contact:
          • Phone Number: 34932483380
        • Principal Investigator:
          • Irene Garcia Diez
      • Barcelona, Spain, 8041
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
          • Phone Number: 34935537007
        • Principal Investigator:
          • Esther Roe Crespo
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron - VHIR
        • Principal Investigator:
          • Josefina Cortes Hernandez
        • Contact:
          • Phone Number: +34934894171
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofía
        • Contact:
          • Phone Number: 34606887057
        • Principal Investigator:
          • Juan Alberto Ruano Ruiz
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
          • Phone Number: 34955012000
        • Principal Investigator:
          • Enrique Jorquera Barquero
    • Barcelona
      • Badalona, Barcelona, Spain, 8916
        • Completed
        • Hospital Universitari Germans Trias i Pujol
    • Cantabria
      • Valladolid, Cantabria, Spain, 47012
        • Recruiting
        • Hospital Universitario Rio Hortega
        • Principal Investigator:
          • Maria Julia Barbado Ajo
        • Contact:
          • Phone Number: 34983420400
    • Castellón
      • Castellon, Castellón, Spain, 12004
        • Recruiting
        • Hospital General de Castellón
        • Principal Investigator:
          • Maria Arantzazu Conesa Mateos
        • Contact:
          • Phone Number: +34964725210
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Completed
        • Hospital Universitario Fundacion Alcorcon
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
        • Contact:
          • Phone Number: 34911916481
        • Principal Investigator:
          • Rita Cabeza Martinez
  • Sweden
      • Stockholm, Sweden, 17176
        • Recruiting
        • Karolinska Universitetssjukhuset - Solna
        • Contact:
          • Phone Number: 46851770000
        • Principal Investigator:
          • Filippa Nyberg
  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Recruiting
        • Centre Hospitalier Universitaire Vaudois (CHUV)
        • Contact:
          • Phone Number: 41213140351
        • Principal Investigator:
          • Michel Gilliet
      • Sankt Gallen, Switzerland, 9007
        • Recruiting
        • Kantonsspital St. Gallen
        • Contact:
          • Phone Number: 41714942030
        • Principal Investigator:
          • Antonio Cozzio
    • Canton of Zurich
      • Zurich-Flughafen, Canton of Zurich, Switzerland, 8058
        • Recruiting
        • Universitaetsspital Zuerich
        • Contact:
          • Phone Number: 41432539940
        • Principal Investigator:
          • Julia-Tatjana Maul
  • Taiwan
      • Changhua, Taiwan, 50004
        • Completed
        • Changhua Christian Medical Foundation Changhua Christian Hospital
      • Kaohsiung City, Taiwan, 833
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
      • Taichung, Taiwan, 40201
        • Recruiting
        • Chung Shan Medical University Hospital
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Phone Number: 886228757340
        • Principal Investigator:
          • Yun-Ting Chang
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Recruiting
        • CNE Cherkasy Regional Hospital of Cherkasy Regional Council
        • Contact:
          • Phone Number: +380979421791
        • Principal Investigator:
          • Anna Kulyk
      • Ivano-Frankivsk, Ukraine, 76018
        • Recruiting
        • CNCE Regional Clinical Hospital of Ivano-Frankivsk Regional Council, Dept of Rheumatology
        • Contact:
          • Phone Number: +380503388571
        • Principal Investigator:
          • Roman Yatsyshyn
      • Kyiv, Ukraine, 02091
        • Recruiting
        • Med Center 'Ok!Clinic+' LLC "International Institute of Clinical Research"
        • Principal Investigator:
          • Viktoriia Kachur
      • Kyiv, Ukraine, 02002
        • Recruiting
        • Medical Center Artes Medicum LLC
        • Contact:
          • Phone Number: +380505048489
        • Principal Investigator:
          • Mykhailo Puhach
      • Lutsk, Ukraine, 43005
        • Recruiting
        • Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council
        • Principal Investigator:
          • Nataliia Sydor
        • Contact:
          • Phone Number: +380332773119
      • Lviv, Ukraine, 79010
        • Recruiting
        • UH of State NPE "Danulo Halytsky NMU in Lviv" CID, Rheum. Dept. of Marian Panchyshyn Campus
        • Contact:
          • Phone Number: +380322767603
        • Principal Investigator:
          • Valentyna Chopyak
      • Poltava, Ukraine, 36011
        • Recruiting
        • Communal Enterprise M.V.Sklifosovskyi Poltava Regional Clinical Hospital of Poltava Regional Council
        • Principal Investigator:
          • Maksym Tkachenko
        • Contact:
          • Phone Number: +380994833900
      • Ternopil, Ukraine, 46002
        • Recruiting
        • CNE Ternopil Reg Clinical Hospital TRC, Dept of Rheumatology, SHEI I.Ya.HorbachevskyiTernopil SMU
        • Contact:
          • Phone Number: +380352273378
        • Principal Investigator:
          • Svitlana Smiyan
      • Uzhhorod, Ukraine, 88000
        • Recruiting
        • ZAKARPATTIA ENDOCLINIC LLC, Medical Center Endoclinic
        • Contact:
          • Phone Number: +380506690367
        • Principal Investigator:
          • Kornelia Hranchak
      • Vinnytsia, Ukraine, 21001
        • Recruiting
        • Private Small Enterprise Medical Center Pulse
        • Principal Investigator:
          • Maryna Ziabchenko
        • Contact:
          • Phone Number: +380682093343
      • Vinnytsia, Ukraine, 21018
        • Recruiting
        • СNE M.I. Pyrogov RCH of Vinnytsia RC HSC Reum Osteo Bio Th
        • Principal Investigator:
          • Mykola Stanislavchuk
        • Contact:
          • Phone Number: +380506986684
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, E11 1NR
        • Recruiting
        • Whipps Cross University Hospital
        • Contact:
          • Phone Number: 4420853955226730
        • Principal Investigator:
          • Anthony Bewley
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Manchester Royal Infirmary
        • Contact:
          • Phone Number: 441612761234
        • Principal Investigator:
          • Benjamin J Parker
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2GW
        • Recruiting
        • Queen Elizabeth Hospital
        • Principal Investigator:
          • Agustin Martin-Clavijo
        • Contact:
          • Phone Number: 441216272000
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Recruiting
        • Chapel Allerton Hospital
        • Contact:
          • Phone Number: 441133924357
        • Principal Investigator:
          • Philip M Laws
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Recruiting
        • Pinnacle Research Group, LLC
        • Contact:
          • Phone Number: 256-236-0055
        • Principal Investigator:
          • Vishala L Chindalore
      • Birmingham, Alabama, United States, 35233-7340
        • Recruiting
        • UAB Center for Women's Reproductive Health
        • Contact:
          • Phone Number: 205-502-9960
        • Principal Investigator:
          • Lauren Graham
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Arizona Arthritis & Rheumatology Research, PLLC
        • Principal Investigator:
          • Saima Chohan
        • Contact:
          • Phone Number: 480-443-8400
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • The Regents of the University of California
        • Contact:
          • Phone Number: 858-246-2382
        • Principal Investigator:
          • Arthur Francis Kavanaugh
      • Los Angeles, California, United States, 90045
        • Recruiting
        • Dermatology Research Associates
        • Principal Investigator:
          • Howard Lee Sofen
        • Contact:
          • Phone Number: 310-337-7171
      • Santa Monica, California, United States, 90404
        • Completed
        • Clinical Science Institute
      • Upland, California, United States, 91786
        • Recruiting
        • Inland Rheumatology Clinical Trials, Inc.
        • Contact:
          • Phone Number: 909-296-8700
        • Principal Investigator:
          • Eric Cheng-Jer Lee
    • Colorado
      • Denver, Colorado, United States, 80230
        • Completed
        • Denver Arthritis Clinic
    • Florida
      • DeBary, Florida, United States, 32713
        • Recruiting
        • Omega Research Debary, LLC
        • Principal Investigator:
          • Kwabena Ayesu
        • Contact:
          • Phone Number: 407-988-1075
      • Fort Lauderdale, Florida, United States, 33334
        • Completed
        • Centre for Rheumatology, Immunology and Arthritis
      • Gainesville, Florida, United States, 32610
        • Completed
        • University of Florida
      • Miami, Florida, United States, 33125
        • Recruiting
        • University of Miami Miller School of Medicine
        • Principal Investigator:
          • Andrea Dale Maderal
        • Contact:
          • Phone Number: 305-542-3535
      • Miami, Florida, United States, 33134
        • Completed
        • Medical Research Center of Miami
      • Miami, Florida, United States, 33175
        • Recruiting
        • Diverse Clinical Research LLC
        • Contact:
          • Phone Number: 305-582-7752
        • Principal Investigator:
          • Mireya Garcia
      • Miami, Florida, United States, 33126
        • Recruiting
        • Millennium Medical Research, LLC
        • Contact:
          • Phone Number: 800-377-2235
        • Principal Investigator:
          • Ramon M Moreda
      • Miami Lakes, Florida, United States, 33014
        • Completed
        • Charisma Medical and Research Center
      • Plantation, Florida, United States, 33317
        • Recruiting
        • Leading Edge Dermatology
        • Principal Investigator:
          • Elyse Julian
        • Contact:
          • Phone Number: 713-487-8680
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Completed
        • Augusta University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Completed
        • Rush University Medical Center
      • Rockford, Illinois, United States, 61114
        • Completed
        • OrthoIllinois
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Completed
        • Dawes Fretzin Clinical Research Group, LLC
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
        • Recruiting
        • Equity Medical
        • Contact:
          • Phone Number: 844-378-9633
        • Principal Investigator:
          • David J. Johnson
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • LSU Health Sciences Center Shreveport
        • Principal Investigator:
          • Samina Hayat
        • Contact:
          • Phone Number: 318-675-5930
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
          • Phone Number: 617-732-6378
        • Principal Investigator:
          • Joseph F. Merola
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Contact:
          • Phone Number: 617-636-0156
        • Principal Investigator:
          • Gabriela A Cobos
      • Natick, Massachusetts, United States, 01760
        • Completed
        • Essential Dermatology
      • Quincy, Massachusetts, United States, 02169
        • Completed
        • Beacon Clinical Research, LLC
      • Worcester, Massachusetts, United States, 01655
        • Completed
        • University of Massachusetts, Worcester
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Recruiting
        • David Fivenson, MD, Dermatology, PLLC
        • Contact:
          • Phone Number: 734-712-3376
        • Principal Investigator:
          • David P Fivenson
      • Auburn Hills, Michigan, United States, 48326
        • Recruiting
        • Oakland Hills Dermatology
        • Contact:
          • Phone Number: 248-858-2255
        • Principal Investigator:
          • Christofer Buatti
      • Flint, Michigan, United States, 48504
        • Completed
        • AA MRC LLC Ahmed Arif Medical Research Center
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Revival Research Institute, LLC
        • Principal Investigator:
          • Ali Moiin
        • Contact:
          • Phone Number: 248-590-0298
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Saint Louis University
        • Contact:
          • Phone Number: 314-256-3454
        • Principal Investigator:
          • M Yadira Hurley
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Completed
        • University of Nebraska Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Completed
        • Albuquerque Center for Rheumatology
      • Albuquerque, New Mexico, United States, 87106
        • Completed
        • University of New Mexico School of Medicine
    • New York
      • Brooklyn, New York, United States, 11220
        • Recruiting
        • NYU Langone Brooklyn
        • Contact:
          • Phone Number: 929-455-2399
        • Principal Investigator:
          • David Harry Goddard
      • Fairport, New York, United States, 14450
        • Recruiting
        • Universal Dermatology, PLLC
        • Contact:
          • Phone Number: 585-275-7546
        • Principal Investigator:
          • Brian Poligone
      • Great Neck, New York, United States, 11021
        • Recruiting
        • Northwell Health, Inc. PRIME
        • Contact:
          • Phone Number: 516-708-2557
        • Principal Investigator:
          • Richard A Furie
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
          • Phone Number: 212-305-4308
        • Principal Investigator:
          • Laura B Geraldino Pardilla
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
          • Phone Number: 919-843-6619
        • Principal Investigator:
          • Saira Zafar Sheikh
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Dermatology South Durham
        • Contact:
          • Phone Number: 919-385-7546
        • Principal Investigator:
          • Anne Louise Marano
      • Greensboro, North Carolina, United States, 27405
        • Completed
        • Medication Management, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Department of Dermatology
        • Contact:
          • Phone Number: 513-475-7631
        • Principal Investigator:
          • Alan B. Fleischer
      • Cleveland, Ohio, United States, 44106
        • Completed
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43210
        • Completed
        • Ohio State University
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Completed
        • Penn State University Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Principal Investigator:
          • Victoria Patricia Werth
        • Contact:
          • Phone Number: 215-615-2940
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Phone Number: 615-936-4072
        • Principal Investigator:
          • Narender Annapureddy
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Austin Regional Clinic, P.A.
        • Contact:
          • Phone Number: 512-344-0362
        • Principal Investigator:
          • Tina C. Bunch
      • Colleyville, Texas, United States, 76034
        • Recruiting
        • Precision Comprehensive Clinical Research Solutions
        • Principal Investigator:
          • Dhiman Basu
        • Contact:
          • Phone Number: 972-299-8399
      • Dallas, Texas, United States, 75390-8896
        • Recruiting
        • UT southwestern Medical Center
        • Contact:
          • Phone Number: 214-645-2400
        • Principal Investigator:
          • Benjamin Chong
      • Dallas, Texas, United States, 75231
        • Completed
        • Metroplex Clinical Research Center, LLC
      • Frisco, Texas, United States, 75034
        • Recruiting
        • North Texas Center for Clinical Research
        • Contact:
          • Phone Number: 888-635-0552
        • Principal Investigator:
          • Timothy Gale Rodgers
      • Galveston, Texas, United States, 77555-0583
        • Recruiting
        • UTMB Department of Dermatology
        • Contact:
          • Phone Number: 409-772-5047
        • Principal Investigator:
          • Bernard R Gibson
      • Houston, Texas, United States, 77054
        • Completed
        • University of Texas Health Science Center at Houston
      • Waco, Texas, United States, 76710
        • Recruiting
        • Arthritis & Osteoporosis Clinic
        • Principal Investigator:
          • HS Eugene Fung
        • Contact:
          • Phone Number: 254-755-4584
      • Waco, Texas, United States, 76710
        • Completed
        • Velocity Clinical Research Waco
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Health Sciences Center
        • Contact:
          • Phone Number: 801-581-2955
        • Principal Investigator:
          • Jamie W. Rhoads
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Recruiting
        • Open Door Clinical Research
        • Contact:
          • Phone Number: 540-476-8966
        • Principal Investigator:
          • Daniel Hurd
      • Richmond, Virginia, United States, 23233
        • Completed
        • West End Dermatology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations.
  2. Must have active cutaneous manifestations that meet study criteria.
  3. Must have a CLASI-A score ≥10.
  4. Must have an active CLE lesion despite an adequate trial of antimalarial treatment.

Key Exclusion Criteria:

  1. Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
  2. Diagnosis of mixed connective tissue disease [(within 1 year of signing the informed consent form (ICF)] or any history of overlap syndromes of SLE including concomitant presence with rheumatoid arthritis, dermatomyositis and/or polymyositis, systemic sclerosis, psoriatic arthritis, or any other autoimmune disease that may confound the evaluation of the disease activity or the effect of the investigational product. Exceptions for overlap syndrome of SLE include participants with overlap syndrome of SLE with myositis and secondary Sjögren's syndrome at screening is permitted provided the participant also meets the criteria for classification as SLE. A past history of mixed connective tissue disease that over time has developed into a diagnosis of SLE is permitted, provided diagnosis of SLE has been present for at least 1 year.
  3. Active severe lupus nephritis.
  4. Active neuropsychiatric SLE.
  5. Use of intralesional corticosteroids within 1 week prior to Screening and during the study.
  6. Use of immunosuppressive or disease-modifying treatments for SLE or CLE [via an oral, intravenous (IV), or SC route] that were initiated less than 12 weeks prior to screening, have not been at a stable and allowable dose.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A (Phase 2): Litifilimab
Participants will receive litifilimab subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the double-blind placebo-controlled (DBPC) treatment period. Following the DBPC treatment period, participants will receive litifilimab during the extended treatment period (ETP) from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26.
Drug: Litifilimab
Administered as specified in the treatment arm.
Other Names:
  • BIIB059
Placebo Comparator: Part A (Phase 2): Placebo
Participants will receive litifilimab-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab at Week 26.
Drug: Placebo
Administered as specified in the treatment arm.
Experimental: Part B (Phase 3): Litifilimab
Participants will receive litifilimab SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26.
Drug: Litifilimab
Administered as specified in the treatment arm.
Other Names:
  • BIIB059
Placebo Comparator: Part B (Phase 3): Placebo
Participants will receive litifilimab-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab at Week 26.
Drug: Placebo
Administered as specified in the treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Parts A: Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1
Time Frame: Week 16
Week 16
Part B: Percentage of Participants who Achieve Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-70) Response, Defined as ≥ 70% Decrease in CLASI-A Score From Baseline
Time Frame: Baseline to Week 24
Baseline to Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Part A: Percentage of Participants With a CLASI-70 Response at Week 52 Among CLASI-70 Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab During the DBPC Treatment Period (TP)
Time Frame: Week 52
Week 52
Part A: Percentage of Participants With CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP
Time Frame: Week 52
Week 52
Part A: Percentage of Participants With CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Responders at Weeks 16 &24, Respectively, who Were Assigned to Receive Litifilimab in DBPC TP
Time Frame: Week 52
Week 52
Part A: Percentage of Participants With CLA-IGA-R OMC Score of 0 at Week 52 Among CLA-IGA-R OMC Responders With CLA-IGA-R OMC Score of 0 at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Litifilimab During DBPC TP
Time Frame: Week 52
Week 52
Part A: Percentage of Participants With CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab in DBPC TP
Time Frame: Week 52
Week 52
Part A: Percentage of Participants With a CLASI-70 Response at Week 52 Among CLASI-70 Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP
Time Frame: Week 52
Week 52
Part A: Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP
Time Frame: Week 52
Week 52
Part A: Percentage of Participants With CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Nonresponders at Weeks 16 and 24, Respectively, who Were Assigned to Receive Placebo in DBPC TP
Time Frame: Week 52
Week 52
Part A: Percentage of Participants With a CLA-IGA-R OMC Score of 0 at Week 52 Among CLA-IGA-R OMC Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP
Time Frame: Week 52
Week 52
Part A: Percentage of Participants who Have CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Nonresponders at Weeks 16 and 24, Respectively, who Were Randomly Assigned to Receive Placebo in DBPC TP
Time Frame: Week 52
Week 52
Part A: Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 16
Time Frame: Up to Week 16
Up to Week 16
Part A: Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score at Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Part A: Percent Change in CLASI-D Score
Time Frame: Baseline to Week 52
Baseline to Week 52
Part B: Percentage of Participants who Achieve a CLASI A score of 0 to 3
Time Frame: Week 24
Week 24
Part B: Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1 and at Least 2-Point Improvement From Baseline at Week 24, for Participants who had CLA-IGA-R OMC Score ≥ 2 at Baseline
Time Frame: Week 24
Week 24
Part B: Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in Full Analysis Set (FAS), who had CLA-IGA-R Erythema Score ≥3 and Other OMC Score ≥3 at Baseline
Time Frame: Weeks 16 and 24
Weeks 16 and 24
Part B: Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in FAS, who had CLA-IGA-R Erythema Score ≥3 and OMC Score ≥3 at Baseline
Time Frame: Weeks 16 and 24
Weeks 16 and 24
Part B: Percentage of Participants who Achieve CLA IGA R Erythema Score of 0 or 1
Time Frame: Up to Week 24
Up to Week 24
Part B: Percentage of Participants who Achieve at Least 1 Level of Improvement From Baseline in the CLA-IGA-R Erythema Score
Time Frame: Up to Week 24
Up to Week 24
Part B: Percentage of Participants who Achieve a CLASI-A Score of 0 to 5
Time Frame: Up to Week 24
Up to Week 24
Part B: Percentage of Participants who Achieve a CLASI-50a Response, Defined as a ≥ 50% Decrease in Baseline CLASI-A Score in Addition to Achieving Mild Disease Severity With a CLASI-A Score <10 at Week 16 and Week 24, Respectively
Time Frame: Weeks 16 and 24
Weeks 16 and 24
Part B: Percentage of Participants With a CLASI 70 Response at Week 52 Among CLASI-70 Responders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP
Time Frame: Week 52
Week 52
Part B: Percentage of Participants With a CLASI 50 Response at Week 52 Among CLASI-50 Responders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP
Time Frame: Week 52
Week 52
Part B: Percentage of Participants With a CLASI A 0 to 3 Response at Week 52 Among CLASI-A 0 to 3 Responders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP
Time Frame: Week 52
Week 52
Part B: Percentage of Participants With a CLA IGA R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Responders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP
Time Frame: Week 52
Week 52
Part B: Percentage of Participants With a CLA IGA R OMC score of 0 at Week 52 Among CLA IGA R OMC Responders With a CLA-IGA-R OMC Score of 0 at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP
Time Frame: Week 52
Week 52
Part B: Percentage of Participants With a CLA IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Responders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP
Time Frame: Week 52
Week 52
Part B: Percentage of Participants With a CLASI 70 Response at Week 52 Among CLASI-70 Nonresponders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP
Time Frame: Week 52
Week 52
Part B: Percentage of Participants With a CLASI 50 Response at Week 52 Among CLASI-50 Nonresponders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP
Time Frame: Week 52
Week 52
Part B: Percentage of Participants With a CLASI A 0 to 3 Response at Week 52 Among CLASI-A 0 to 3 Nonresponders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP
Time Frame: Week 52
Week 52
Part B: Percentage of Participants With a CLA IGA R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Nonresponders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP
Time Frame: Week 52
Week 52
Part B: Percentage of Participants With a CLA IGA R OMC score of 0 at Week 52 Among CLA IGA R OMC Nonresponders With a CLA-IGA-R OMC Score of 0 at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP
Time Frame: Week 52
Week 52
Part B: Percentage of Participants With a CLA IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Nonresponders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP
Time Frame: Week 52
Week 52
Part B: Absolute Change in CLASI-D Score
Time Frame: Week 52
Week 52
Part B: Percent Change in CLASI-D Score
Time Frame: Week 52
Week 52
Part B: Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL) Score
Time Frame: Part B: Weeks 16, 24 and 52
Part B: Weeks 16, 24 and 52
Part B: Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Time Frame: Part B: Weeks 16, 24 and 52
Part B: Weeks 16, 24 and 52
Part B: Change From Baseline in Numerical Rating Scale (NRS) for Pain in Skin Rash
Time Frame: Part B: Weeks 16, 24 and 52
Part B: Weeks 16, 24 and 52
Part B: Change From Baseline in NRS for Itch in Skin Rash
Time Frame: Part B: Weeks 16, 24 and 52
Part B: Weeks 16, 24 and 52
Parts A and B: Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1
Time Frame: Part A: Week 24; Part B: Weeks 16 and 24
Part A: Week 24; Part B: Weeks 16 and 24
Parts A and B: Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1 and at Least 1 Level of Improvement From Baseline
Time Frame: Part A: Weeks 16 and 24; Part B: Up to Week 24
Part A: Weeks 16 and 24; Part B: Up to Week 24
Parts A and B: Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0
Time Frame: Part A: Weeks 16 and 24; Part B: Up to Week 24
Part A: Weeks 16 and 24; Part B: Up to Week 24
Parts A and B: Percentage of Participants With at Least 1 Level of Improvement From Baseline in CLA-IGA-R OMC Score
Time Frame: Part A: Weeks 16 and 24; Part B: Up to Week 24
Part A: Weeks 16 and 24; Part B: Up to Week 24
Parts A and B: Percentage of Participants who Have a CLA-IGA-R Follicular Activity Score of 0
Time Frame: Part A: Weeks 16 and 24; Part B: Up to Week 24
Part A: Weeks 16 and 24; Part B: Up to Week 24
Parts A and B: Percentage of Participants who Achieve a CLASI-70 Response, Defined as a ≥ 70% Decrease in CLASI-A Score From Baseline
Time Frame: Parts A: Weeks 16 and 24; Part B: Week 12
Parts A: Weeks 16 and 24; Part B: Week 12
Parts A and B: Percentage of Participants who Achieve a CLASI-50 Response, Defined as a ≥ 50% Decrease in CLASI-A Score From Baseline
Time Frame: Part A: Weeks 16 and 24; Part B: Weeks 12 and 24
Part A: Weeks 16 and 24; Part B: Weeks 12 and 24
Parts A and B: Percentage of Participants who Achieve a CLASI-A Score of 0 or 1
Time Frame: Up to Week 24
Up to Week 24
Parts A and B: Percentage of Participants who Achieve a CLASI-A Score of 0 to 3
Time Frame: Up to Week 24
Up to Week 24
Parts A and B: Percentage of Participants who Achieve a CLASI 70 Response
Time Frame: Up to Week 24
Up to Week 24
Parts A and B: Percentage of Participants who Achieve a CLASI 50 Response
Time Frame: Up to Week 24
Up to Week 24
Parts A and B: Percentage of Participants who Achieve a 7-Point Reduction From Baseline in CLASI-A Score
Time Frame: Up to Week 24
Up to Week 24
Parts A and B: Annualized Mild and Moderate Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index Rate and Annualized Severe SFI Rate Through Week 24
Time Frame: Up to Week 24
Up to Week 24
Parts A and B: Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 52
Time Frame: Up to Week 52
Up to Week 52
Parts A and B: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Up to Week 76
Up to Week 76
Parts A and B: Number of Participants With Anti-Litifilimab Antibodies in Serum During the Study
Time Frame: Up to Week 76
Up to Week 76

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2022

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

December 14, 2027

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230LE301
  • 2020-000727-40 (EudraCT Number)
  • EU CT Number (Other Identifier: 2023-503184-42)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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