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

July 2, 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

Active, not 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 Locations

  • Argentina
      • Buenos Aires, Argentina, B1900AXI
        • Hospital Italiano de La Plata
      • Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
        • Clinica Adventista Belgrano
      • Ciudad Autonoma Buenos Aires, Argentina, C1417
        • Centro Privado de Medicina Familiar - Mind Out Research
      • Ciudad Autonoma Buenos Aires, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires
      • Mendoza, Argentina, M5500
        • Instituto de Reumatologia
      • San Juan, Argentina, 5400
        • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1056ABI
        • Cinme - Centro de Investigaciones Metabolicas
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Centro de Investigaciones Medicas Mar del Plata
      • Quilmes, Buenos Aires, Argentina, B1878GEG
        • Instituto de Investigaciones Clinicas Quilmes
      • San Miguel, Buenos Aires, Argentina, 1663
        • Centro de Investigaciones San Miguel
    • Ciudad Autonoma Buenos Aires
      • Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, C1426ABO
        • Fundacion Respirar
      • Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, C1406AGA
        • APRILLUS Asistencia e Investigacion
    • Mendoza Province
      • Villa Nueva, Mendoza Province, Argentina, CP 5519
        • Consultorio Alto Dorrego
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000PBJ
        • Instituto CAICI
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • Centro de Investigaciones Médicas Tucuman
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000ICL
        • Investigaciones Clinicas Tucuman
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Liège, Belgium, 4000
        • Centre Hospitalier Universitaire de Liège
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 03000
        • UZ Leuven
  • Brazil
      • São Paulo, Brazil, 04037-030
        • RDSS Ricardo Diaz Scientific Solution
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-370
        • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
      • Fortaleza, Ceará, Brazil, 60125-000
        • Integrare Terapêutica
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055-450
        • CEDOES - Diagnóstico e Pesquisa
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40150-150
        • Clínica SER da Bahia
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • L2IP - Instituto de Pesquisas Clínicas Ltda.
    • Mato Grosso
      • Santo Ângelo, Mato Grosso, Brazil, 78020-500
        • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Santa Casa de Misericordia de Belo Horizonte
      • Belo Horizonte, Minas Gerais, Brazil, 30180-065
        • Clinica Pulsus
      • Belo Horizonte, Minas Gerais, Brazil, 30150-320
        • Freire Pesquisa Clínica
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • CMiP - Centro Mineiro de Pesquisa
    • Rio Do Janeiro
      • Rio de Janeiro, Rio Do Janeiro, Brazil, 20241-180
        • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
      • Rio de Janeiro, Rio Do Janeiro, Brazil, 22470-220
        • IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda
    • Rio Grande do Sul
      • Lajeado, Rio Grande do Sul, Brazil, 95900-000
        • Hospital Bruno Born
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
        • LMK Serviços Médicos S/S Ltda
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560032
        • Hospital Moinhos de Vento
      • Porto Alegre, Rio Grande do Sul, Brazil, 90430001
        • Núcleo de Pesquisa Clínica do Rio Grande do Sul
    • Rondônia
      • Porto Velho, Rondônia, Brazil, 76804366
        • IPES - Instituto de Pesquisa e Educação em Saúde
    • São Paulo
      • São Bernardo do Campo, São Paulo, Brazil, 09715-090
        • CEMEC - Centro Multidisciplinar de Estudos Clínicos
      • São Paulo, São Paulo, Brazil, 04266-010
        • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
      • Valinhos, São Paulo, Brazil, 13271-130
        • A2Z Clinical Centro Avancado de Pesquisa Clinica
  • Bulgaria
      • Haskovo, Bulgaria, 6300
        • DCC 'Sveti Georgi' EOOD
      • Pleven, Bulgaria, 5800
        • Medical Center Medconsult Pleven OOD
      • Pleven, Bulgaria, 5800
        • UMHAT 'Dr. Georgi Stranski', EAD
      • Rousse, Bulgaria, 7002
        • DCC 1 - Ruse, EOOD
      • Sofia, Bulgaria, 1431
        • DCC 'Alexandrovska', EOOD
      • Sofia, Bulgaria, 1606
        • Military Medical Academy - MHAT - Sofia
      • Sofia, Bulgaria, 1407
        • Ambulatory for Specialized Medical Help - skin and venereal diseases
      • Sofia, Bulgaria, 1463
        • DCC Focus 5 - MEOH OOD
    • Gabrovo
      • Sevlievo, Gabrovo, Bulgaria, 5400
        • DCC-1-Sevlievo EOOD
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2W 4X9
        • Laser Rejuvenation Clinics, Inc.
      • Edmonton, Alberta, Canada, T5J 3S9
        • Laster Rejuvenation Clinics Edmonton D.T. Inc.
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3C 1X3
        • Medicor Research Inc
      • Ottawa, Ontario, Canada, K2C 3N2
        • Dermatology Ottawa Research Centre
    • Quebec
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • DIEX Recherche Sherbrooke Inc.
  • Chile
      • Las Condes, Chile, 7580206
        • Centro Medico SkinMed
      • Santiago, Chile, 7500710
        • BioMedica Research Group
      • Santiago, Chile, 66901
        • Dermacross
      • Santiago, Chile, 8420383
        • CIEC - Centro Internacional de Estudios Clínicos
      • Santiago, Chile, 8331143
        • CeCim Biocinetic
      • Valdivia, Chile, 5090000
        • Clinical Research Chile SpA.
      • Viña del Mar, Chile, 2520598
        • Oncocentro Apys
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, Beijing Municipality, China, 100730
        • Beijing Tongren Hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
    • Guangdong
      • Dongguan, Guangdong, China, 523059
        • Dongguan People's Hospital
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University
      • Shenzhen, Guangdong, China, 518029
        • Shenzhen Second People's Hospital
      • Zhongshan, Guangdong, China, 528400
        • Zhongshan TCM Hospital
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-Sen University
    • Henan
      • Nanyang, Henan, China, 473004
        • Nanyang First People's Hospital
      • Zhengzhou, Henan, China, 450003
        • Henan Provincial People's Hospital
    • Hu'nan
      • Changsha, Hu'nan, China, 410011
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hu'nan, China, 410008
        • Xiangya Hospital of Central South University
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014010
        • The First Affiliated Hospital of Baotou Medical College
    • Jiangsu
      • Nanjing, Jiangsu, China, 210042
        • Hospital for Skin Diseases, Chinese Academy of Medical Sciences
      • Zhenjiang, Jiangsu, China, 212001
        • Affiliated Hospital of Jiangsu University
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Zhongshan Hospital Fudan University
      • Shanghai, Shanghai Municipality, China, 200443
        • Shanghai Skin Disease Hospital
      • Shanghai, Shanghai Municipality, China, 200011
        • Ruijin Hospital of Shanghai Jiaotong University School of Medicine
    • Yunnan
      • Kunming, Yunnan, China, 650101
        • The Second Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital
      • Hangzhou, Zhejiang, China, 310006
        • Hangzhou First People's Hospital
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital of Zhejiang University School of Medicine
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
  • Colombia
      • Bogotá, Colombia, 110221
        • Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 80020
        • Centro de Investigacion Medico Asistencial S.A.S
    • Cundinamarca
      • Zipaquirá, Cundinamarca, Colombia, 250252
        • Healthy Medical Center
    • Santander Department
      • Bucaramanga, Santander Department, Colombia, 680003
        • Servimed S.A.S.
  • France
      • Paris, France, 75020
        • Hopital Tenon
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 6200
        • CHU Nice - Hopital de l Archet
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13385
        • Hôpital de La Timone
    • Calvados
      • Caen, Calvados, France, 14033
        • CHU de Caen - Hopital de la Cote de Nacre
    • Doubs
      • Besançon, Doubs, France, 25030
        • CHU Besançon - Hôpital Jean Minjoz
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31059
        • Hopital Larrey
    • Hauts De Seine
      • Antony, Hauts De Seine, France, 92160
        • Hôpital privé d'Antony
    • Herault
      • Montpellier, Herault, France, 34295
        • Hôpital Saint Eloi
    • Nord
      • Lille, Nord, France, 59037
        • Hopital Claude Huriez - CHU Lille
    • Paris
      • Cedex 10, Paris, France, 75475
        • Hôpital Saint-Louis
    • Rhone
      • Lyon, Rhone, France, 69003
        • Hopital Edouard Herriot - CHU Lyon
  • Germany
      • Berlin, Germany, 10117
        • Charité - Campus Charité Mitte
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Universitaetsklinikum Heidelberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Universitaetsklinikum Erlangen
      • Munich, Bavaria, Germany, 80336
        • LMU-Campus Innenstadt
      • Munich, Bavaria, Germany, 80802
        • Klinikum rechts der Isar der TU Muenchen
      • Regensburg, Bavaria, Germany, 93053
        • Universitaetsklinikum Regensburg
      • Würzburg, Bavaria, Germany, 97080
        • Universitaetsklinikum Wuerzburg
    • Lower Saxony
      • Bad Bentheim, Lower Saxony, Germany, 48455
        • Fachklinik Bad Bentheim Dermatologie
      • Buxtehude, Lower Saxony, Germany, 21614
        • Elbekliniken Buxtehude GmbH
      • Oldenburg, Lower Saxony, Germany, 26133
        • Klinikum Oldenburg AoeR
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany, 52074
        • Universitaetsklinikum Aachen AoeR
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Universitaetsklinikum Bonn AoeR
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Universitaetsklinikum Duesseldorf AoeR
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Universitaetsklinikum Muenster
    • Saxony
      • Dresden, Saxony, Germany, 1307
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 6120
        • Universitaetsklinikum Halle (Saale)
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem
      • Pécs, Hungary, 7632
        • Pécsi Tudományegyetem
      • Szeged, Hungary, 6720
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Florence, Italy, 50121
        • Università degli studi di Firenze
      • Genova, Italy, 16132
        • IRCCS Ospedale Policlinico San Martino
      • Milan, Italy, 20132
        • Ospedale San Raffaele
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Naples, Italy, 80131
        • Azienda Ospedaliera Universitaria Policlinico 'Federico II'
      • Roma, Italy, 137
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 457-8510
        • Jcho Chukyo Hospital
      • Nagoya, Aichi-ken, Japan, 460-0001
        • NHO Nagoya Medical Center
      • Toyoake-shi, Aichi-ken, Japan, 470-1192
        • Fujita Health University Hospital
    • Aomori
      • Aomori, Aomori, Japan, 030-8553
        • Aomori Prefectural Central Hospital
    • Chiba
      • Urayasu-shi, Chiba, Japan, 279-0021
        • Juntendo University Urayasu Hospital
    • Fukui
      • Yoshida-gun, Fukui, Japan, 910-1193
        • University of Fukui Hospital
    • Fukuoka
      • Kitakyushu-shi, Fukuoka, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Hyōgo
      • Kakogawa-shi, Hyōgo, Japan, 675-8611
        • Kakogawa Central City Hospital
      • Ono-shi, Hyōgo, Japan, 675-1392
        • Kita Harima Medical Center
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • St. Marianna University Hospital
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
      • Yokohama, Kanagawa, Japan, 236-0004
        • Yokohama City University Hospital
      • Yokohama, Kanagawa, Japan, 245-8575
        • NHO Yokohama Medical Center
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
    • Niigata
      • Niigata, Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8607
        • Japanese Red Cross Okayama Hospital
    • Osaka
      • Kawachinagano-shi, Osaka, Japan, 586-8521
        • NHO Osaka Minami Medical Center
      • Osaka, Osaka, Japan, 543-8922
        • Daini Osaka Police Hospital
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Kindai University Hospital
      • Suita-shi, Osaka, Japan, 565-0871
        • Osaka University Hospital
      • Takatsuki-shi, Osaka, Japan, 569-1096
        • Takatsuki Red Cross Hospital
    • Shiga
      • Ōtsu, Shiga, Japan, 520-2192
        • Shiga University of Medical Science Hospital
    • Shimane
      • Izumo-shi, Shimane, Japan, 693-8501
        • Shimane University Hospital
    • Tokyo-To
      • Itabashi-ku, Tokyo-To, Japan, 173-8606
        • Teikyo University Hospital
      • Shinagawa-ku, Tokyo-To, Japan, 142-0054
        • Showa University East Hospital
    • Wakayama
      • Wakayama, Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital
  • Mexico
      • Aguascalientes, Mexico, 20127
        • Derma Norte del Bajio S.C.
      • Chihuahua City, Mexico, 31000
        • Investigacion y Biomedicina de Chihuahua, S.C.
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44959
        • Centro de investigacion medica y reumatologia
    • Mexico City
      • Mexico City, Mexico City, Mexico, 3720
        • Centro de Investigacion Clínica GRAMEL S.C
      • Mexico City, Mexico City, Mexico, 6700
        • Clinstile, S.A. de C.V.
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62448
        • Consultorio Privado Dr. Miguel Cortes Hernandez
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Medical Care & Research SA de CV
  • Peru
      • Lima, Peru, Lima 33
        • Invest Clinicas Sac Inst de Ginecologia y Reproduccion
      • Lima, Peru, Lima 11
        • ACQ MEDIC SAC - Centro de Investigacion Clinica Inmunoreumatologia
  • Philippines
      • Cebu City, Philippines, 6000
        • Cebu Doctors University Hospital
      • City of Taguig, Philippines, 1642
        • Ospital ng Makati
      • Lipa City, Philippines, 4217
        • Mary Mediatrix Medical Center
      • Manila, Philippines, 1000
        • Philippine General Hospital
      • Manila, Philippines, 1000
        • Medical Center Manila
      • Manila, Philippines, 1012
        • Jose R. Reyes Memorial Medical Center
      • Pasig, Philippines, 1605
        • The Medical City
      • Quezon City, Philippines, 1102
        • St. Luke's Medical Center
      • Quezon City, Metro Manila, Philippines, 1118
        • Far Eastern University - Dr. Nicanor Reyes Medical Foundation
      • San Fenando, La Union, Philippines, 2500
        • Ilocos Training and Regional Medical Center
      • San Fernando City, La Union, Philippines, 2500
        • Lorma Medical Center
    • Pampanga
      • Mabalacat, Pampanga, Philippines, 2023
        • The Medical City Clark
  • Poland
      • Kielce, Poland, 25-553
        • Dermedic Jacek Zdybski
      • Krakow, Poland, 31-501
        • SPZOZ Szpital Uniwersytecki w Krakowie
      • Krakow, Poland, 31-513
        • Promed P.Lach R.Glowacki spolka jawna, Centrum Medyczne PROMED
      • Krakow, Poland, 31-530
        • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski
      • Krosno, Poland, 38-400
        • MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapinski
      • Lodz, Poland, 90-436
        • Dermoklinika Centrum Medyczne SC M Kierstan J Narbutt A Lesiak
      • Rzeszów, Poland, 35-055
        • Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina
      • Warsaw, Poland, 00-874
        • MICS Centrum Medyczne Warszawa
      • Warsaw, Poland, 02-962
        • Royalderm
      • Warsaw, Poland, 02-008
        • Szpital Kliniczny Dzieciatka Jezus
      • Wroclaw, Poland, 50-566
        • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC)
      • Lisbon, Portugal, 1349-019
        • Hospital de Egas Moniz
      • Lisbon, Portugal, 1998-018
        • Hospital CUF Descobertas
      • Porto, Portugal, 4099-001
        • Centro Hospitalar Universitártio do Porto, E.P.E.
      • Viana do Castelo, Portugal, 4904-858
        • Unidade Local de Saúde do Alto Minho, E.P.E.
  • Puerto Rico
      • Caguas, Puerto Rico, 00727
        • Dr. Samuel Sanchez PSC
      • San Juan, Puerto Rico, 917
        • GCM Medical Group PSC - Hato Rey
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • King Faisal Specialist Hospital & Research Center
      • Riyadh, Saudi Arabia, 11461
        • King Saud University
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute of Rheumatology
      • Belgrade, Serbia, 11000
        • University Clinical Center of Serbia
      • Kragujevac, Serbia, 34000
        • University Clinical Center Kragujevac
      • Novi Sad, Serbia, 21000
        • Clinical Center of Vojvodina
  • Slovakia
      • Košice, Slovakia, 4011
        • Artromac n.o.
      • Piešťany, Slovakia, 92112
        • Narodny ustav reumatickych chorob
  • South Korea
      • Daejeon, South Korea, 35015
        • Chungnam national university hospital
      • Gwangju, South Korea, 61469
        • Chonnam National University Hospital
      • Seoul, South Korea, 4763
        • Hanyang University Seoul Hospital
      • Seoul, South Korea, 6591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, South Korea, 3722
        • Severance Hospital, Yonsei University Health System
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, South Korea, 15355
        • Korea University Ansan Hospital
      • Suwon, Gyeonggi-do, South Korea, 16499
        • Ajou University Hospital
  • Spain
      • A Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruna
      • Barcelona, Spain, 8041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 8003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron - VHIR
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
    • Barcelona
      • Badalona, Barcelona, Spain, 8916
        • Hospital Universitari Germans Trias i Pujol
    • Cantabria
      • Valladolid, Cantabria, Spain, 47012
        • Hospital Universitario Rio Hortega
    • Castellón
      • Castellon, Castellón, Spain, 12004
        • Hospital General de Castellon
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska Universitetssjukhuset - Solna
  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois (CHUV)
      • Sankt Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen
    • Canton of Zurich
      • Zurich-Flughafen, Canton of Zurich, Switzerland, 8058
        • Universitaetsspital Zuerich
  • Taiwan
      • Changhua, Taiwan, 50004
        • Changhua Christian Medical Foundation Changhua Christian Hospital
      • Kaohsiung City, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • CNE Cherkasy Regional Hospital of Cherkasy Regional Council
      • Ivano-Frankivsk, Ukraine, 76018
        • CNCE Regional Clinical Hospital of Ivano-Frankivsk Regional Council, Dept of Rheumatology
      • Kyiv, Ukraine, 02002
        • Medical Center Artes Medicum LLC
      • Kyiv, Ukraine, 02091
        • Med Center 'Ok!Clinic+' LLC "International Institute of Clinical Research"
      • Lutsk, Ukraine, 43005
        • Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council
      • Lviv, Ukraine, 79010
        • UH of State NPE "Danulo Halytsky NMU in Lviv" CID, Rheum. Dept. of Marian Panchyshyn Campus
      • Poltava, Ukraine, 36011
        • Communal Enterprise M.V.Sklifosovskyi Poltava Regional Clinical Hospital of Poltava Regional Council
      • Ternopil, Ukraine, 46002
        • CNE Ternopil Reg Clinical Hospital TRC, Dept of Rheumatology, SHEI I.Ya.HorbachevskyiTernopil SMU
      • Uzhhorod, Ukraine, 88000
        • ZAKARPATTIA ENDOCLINIC LLC, Medical Center Endoclinic
      • Vinnytsia, Ukraine, 21001
        • Private Small Enterprise Medical Center Pulse
      • Vinnytsia, Ukraine, 21018
        • СNE M.I. Pyrogov RCH of Vinnytsia RC HSC Reum Osteo Bio Th
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, E11 1NR
        • Whipps Cross University Hospital
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2GW
        • Queen Elizabeth Hospital
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Chapel Allerton Hospital
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
      • Birmingham, Alabama, United States, 35233-7340
        • UAB Center for Women's Reproductive Health
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Arizona Arthritis & Rheumatology Research, PLLC
    • California
      • La Jolla, California, United States, 92037
        • The Regents of the University of California
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
      • Upland, California, United States, 91786
        • Inland Rheumatology Clinical Trials, Inc.
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic
    • Florida
      • DeBary, Florida, United States, 32713
        • Omega Research Debary, LLC
      • Fort Lauderdale, Florida, United States, 33334
        • Centre for Rheumatology, Immunology and Arthritis
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Miami, Florida, United States, 33125
        • University of Miami Miller School of Medicine
      • Miami, Florida, United States, 33134
        • Medical Research Center of Miami
      • Miami, Florida, United States, 33126
        • Millennium Medical Research, LLC
      • Miami, Florida, United States, 33175
        • Diverse Clinical Research LLC
      • Miami Lakes, Florida, United States, 33014
        • Charisma Medical and Research Center
      • Plantation, Florida, United States, 33317
        • Leading Edge Dermatology
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Rockford, Illinois, United States, 61114
        • Orthoillinois
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group, LLC
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
        • Equity Medical
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • LSU Health Sciences Center Shreveport
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Natick, Massachusetts, United States, 01760
        • Essential Dermatology
      • Quincy, Massachusetts, United States, 02169
        • Beacon Clinical Research, LLC
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts, Worcester
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • David Fivenson, MD, Dermatology, PLLC
      • Auburn Hills, Michigan, United States, 48326
        • Oakland Hills Dermatology
      • Flint, Michigan, United States, 48504
        • AA MRC LLC Ahmed Arif Medical Research Center
      • Troy, Michigan, United States, 48084
        • Revival Research Institute, LLC
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Saint Louis University
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico School of Medicine
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Center for Rheumatology
    • New York
      • Brooklyn, New York, United States, 11220
        • NYU Langone Brooklyn
      • Fairport, New York, United States, 14450
        • Universal Dermatology, PLLC
      • Great Neck, New York, United States, 11021
        • Northwell Health, Inc. PRIME
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • Staten Island, New York, United States, 10309
        • Hawthorne Health
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke Dermatology South Durham
      • Greensboro, North Carolina, United States, 27405
        • Medication Management, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Department of Dermatology
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State University Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Austin, Texas, United States, 78731
        • Austin Regional Clinic, P.A.
      • Colleyville, Texas, United States, 76034
        • Precision Comprehensive Clinical Research Solutions
      • Dallas, Texas, United States, 75231
        • Metroplex Clinical Research Center, LLC
      • Dallas, Texas, United States, 75390-8896
        • UT Southwestern Medical Center
      • Frisco, Texas, United States, 75034
        • North Texas Center for Clinical Research
      • Galveston, Texas, United States, 77555-0583
        • UTMB Department of Dermatology
      • Houston, Texas, United States, 77054
        • University of Texas Health Science Center at Houston
      • Waco, Texas, United States, 76710
        • Arthritis & Osteoporosis Clinic
      • Waco, Texas, United States, 76710
        • Velocity Clinical Research Waco
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health Sciences Center
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Open Door Clinical Research
      • Richmond, Virginia, United States, 23233
        • 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)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 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: 2023-505634-94)

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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