A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus (TOPAZ-2)

April 16, 2024 updated by: Biogen

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants.

The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is:

- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS).

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 SLE have on the quality of life of participants using a group of questionnaires.

The study will be done as follows:

  • After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine.
  • All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications.
  • Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
  • There will be a follow-up safety period that lasts up to 24 weeks.
  • In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

540

Phase

  • 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
      • Ciudad Autonoma Buenos Aires, Argentina, C1417
        • Recruiting
        • Centro Privado de Medicina Familiar - Mind Out Research
        • Principal Investigator:
          • Leonardo Naftal
        • Contact:
          • Phone Number: +5491149273479
      • Ciudad Autonoma Buenos Aires, Argentina, C1013AAB
        • Recruiting
        • Stat Research S.A.
        • Contact:
          • Phone Number: 541561678705
        • Principal Investigator:
          • Alejandro Brigante
      • Ciudad Autonoma Buenos Aires, Argentina, 1425
        • Recruiting
        • Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
        • Contact:
          • Phone Number: +541148019001
        • Principal Investigator:
          • Natalia Carolina Mariasch
      • Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
        • Recruiting
        • Organizacion Medica de Investigacion (OMI)
        • Principal Investigator:
          • Maria Jose Lopez Meiller
        • Contact:
          • Phone Number: +541140141500
      • Ciudad Autonoma de Buenos Aires, Argentina, C1425
        • Recruiting
        • Centro Medico Barrio Parque
        • Principal Investigator:
          • Anastasia Secco
        • Contact:
          • Phone Number: +541566278147
      • Mendoza, Argentina, M5500
        • Recruiting
        • Instituto de Reumatología
        • 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
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1221ADC
        • Recruiting
        • Hospital General de Agudos Dr. J. M. Ramos Mejia
        • Principal Investigator:
          • Eduardo Kerzberg
        • Contact:
          • Phone Number: +541149311178
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Recruiting
        • Centro de Investigaciones Médicas Mar del Plata
        • Principal Investigator:
          • Gladys Alicia Testa
        • Contact:
          • Phone Number: +5492235603218
      • Mar del Plata, Buenos Aires, Argentina, B7600GNY
        • Recruiting
        • Policlìnica Red Omip S.A - Ensayos Clinicos GC
        • Contact:
          • Phone Number: +542234862444
        • Principal Investigator:
          • Monica Nieves Regidor
      • San Miguel, Buenos Aires, Argentina, B1663
        • Recruiting
        • Centro Dermatologico Schejtman
        • Principal Investigator:
          • Alejandro Martinez Muñoz
        • Contact:
          • Phone Number: 541145719929
    • Ciudad Autonoma Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, C1406AGA
        • Recruiting
        • APRILLUS Asistencia e Investigacion
        • Principal Investigator:
          • Pablo Alejandro Mannucci Walter
        • Contact:
          • Phone Number: +541567415099
    • Provincia De Buenos Aires
      • Buenos Aires, Provincia De Buenos Aires, Argentina, B1878
        • Recruiting
        • Instituto De Investigaciones Clinicas Quilmes
        • Principal Investigator:
          • Jose Luis Velasco Zamora
        • Contact:
          • Phone Number: +5491135804733
      • Buenos Aires, Provincia De Buenos Aires, Argentina, B1900
        • Recruiting
        • Hospital Italiano de la Plata
        • Principal Investigator:
          • Rodrigo Nicolas Garcia Salinas
        • Contact:
          • Phone Number: +542214176839
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
        • Recruiting
        • Centro de Investigaciones Médicas Tucumán
        • Principal Investigator:
          • Walter Javier Spindler
        • Contact:
          • Phone Number: +543814200180
      • San Miguel de Tucumán, Tucuman, Argentina, T4000ICL
        • Recruiting
        • Investigaciones Clinicas Tucuman
        • Principal Investigator:
          • Veronica Ines Bellomio
        • Contact:
          • Phone Number: +5493815932070
  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
          • Phone Number: +3216342541
        • Principal Investigator:
          • Ellen De Langhe
      • Liege, Belgium, 4000
        • Recruiting
        • CHU de Liège
        • Contact:
          • Phone Number: +3243667863
        • Principal Investigator:
          • Christian Von Frenckell
  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 6L2
        • Recruiting
        • The Waterside Clinic
        • Contact:
          • Phone Number: 7052521376
        • Principal Investigator:
          • Derek Haaland
      • Hamilton, Ontario, Canada, L8V 1C3
        • Recruiting
        • Hamilton Health Sciences Corporation
        • Contact:
          • Phone Number: 905521210076401
        • Principal Investigator:
          • Mark Matsos
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital - General Campus
        • Contact:
          • Phone Number: 6137388400
        • Principal Investigator:
          • Catherine Ivory
  • China
      • Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital Capital Medical University
      • Beijing, China, 100020
        • Recruiting
        • Beijing Chaoyang Hospital, Capital Medical University
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 510317
        • Recruiting
        • Guangdong Second Provincial General Hospital
      • Shenzhen, Guangdong, China, 518020
        • Recruiting
        • Shenzhen People's Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital, Central South University
      • ZhuZhou, Hunan, China, 412000
        • Recruiting
        • ZhuZhou Central Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
      • Pingxiang, Jiangxi, China, 337055
        • Recruiting
        • Jiangxi Pingxiang People's Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
      • Yanji, Jilin, China, 133000
        • Recruiting
        • Yanbian University Hospital (Yanbian Hospital)
    • Jiujiang
      • Jiujiang, Jiujiang, China, 332000
        • Recruiting
        • Jiujiang No.1 People's Hospital
    • Shandong
      • Binzhou, Shandong, China, 256603
        • Recruiting
        • Binzhou Medical University Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200001
        • Recruiting
        • Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
      • Shanghai, Shanghai, China, 200011
        • Recruiting
        • Ruijin Hospital of Shanghai Jiaotong University School of Medicine
    • Sichuan
      • Chengdu, Sichuan, China, 610500
        • Recruiting
        • The First Affiliated Hospital of Chengdu Medical College
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • The First Affiliated Hospital of Ningbo University
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • Wenzhou People's Hospital
  • Colombia
      • Barranquilla, Colombia, 080020
        • Recruiting
        • Centro de Investigacion Medico Asistencial S.A.S
      • Barranquilla, Colombia, 080020
        • Recruiting
        • Clínica de la Costa Ltda.
      • Bogotá, Colombia, 110221
        • Recruiting
        • Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.
      • Bucaramanga, Colombia, 680003
        • Recruiting
        • Servimed S.A.S.
      • Cali, Colombia, 760001
        • Recruiting
        • IPS Centro Medico Julián Coronel S.A.
      • Chia, Colombia, 250001
        • Recruiting
        • Preventive Care Ltda
      • Zipaquirá, Colombia, 250252
        • Recruiting
        • Healthy Medical Center
  • Czechia
      • Brno, Czechia, 638 00
        • Recruiting
        • Revmatologie s.r.o.
        • Principal Investigator:
          • Leona Prochazkova
        • Contact:
          • Phone Number: 420543182277
      • Olomouc, Czechia, 77520
        • Recruiting
        • Fakultni nemocnice Olomouc
        • Contact:
          • Phone Number: 420585853374
        • Principal Investigator:
          • Pavel Horak
  • Germany
    • Niedersachsen
      • Gottingen, Niedersachsen, Germany, 37075
        • Recruiting
        • Universitaetsmedizin Goettingen
        • Contact:
          • Phone Number: +4915146509138
        • Principal Investigator:
          • Peter Korsten
      • Hannover, Niedersachsen, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
          • Phone Number: +495115325252
        • Principal Investigator:
          • Torsten Witte
    • Nordrhein Westfalen
      • Koeln, Nordrhein Westfalen, Germany, 50937
        • Recruiting
        • Universitaetsklinikum Koeln
        • Principal Investigator:
          • David Kofler
        • Contact:
          • Phone Number: +492214783593
    • Rheinland Pfalz
      • Mainz, Rheinland Pfalz, Germany, 55131
        • Recruiting
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
        • Contact:
          • Phone Number: +496131176774
        • Principal Investigator:
          • Julia Weinmann-Menke
  • Hungary
      • Budapest, Hungary, 1097
        • Recruiting
        • Del-Pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
        • Principal Investigator:
          • Janos Kadar
        • Contact:
          • Phone Number: +36209266272
      • Budapest, Hungary, 1036
        • Recruiting
        • Obudai Egeszsegugyi Centrum Kft.
        • Principal Investigator:
          • Magdolna Nagy
        • Contact:
          • Phone Number: +36309315724
      • Gyula, Hungary, 5700
        • Recruiting
        • Bekes Varmegyei Kozponti Korhaz
        • Contact:
          • Phone Number: +36703678253
        • Principal Investigator:
          • Tibor Martyin
      • Szekesfehervar, Hungary, 8000
        • Recruiting
        • Vita Verum Medical Egeszsegugyi Szolgaltato Bt.
        • Principal Investigator:
          • Tunde Varga
        • Contact:
          • Phone Number: +36304463463
      • Veszprem, Hungary, 8200
        • Recruiting
        • Vital Medical Center
        • Principal Investigator:
          • Edit Drescher
        • Contact:
          • Phone Number: +36309930382
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Center
        • Contact:
          • Phone Number: +97247772988
        • Principal Investigator:
          • Alexandra Balbir-Gurman
      • Kfar- Sava, Israel, 4428164
        • Recruiting
        • Meir Medical Center
        • Contact:
          • Phone Number: +972523671735
        • Principal Investigator:
          • Yair Levy
      • Petach-Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center-Beilinson Campus
        • Contact:
          • Phone Number: +97239376947
        • Principal Investigator:
          • Yair Molad
      • Ramat Gan, Israel, 5262001
        • Recruiting
        • Chaim Sheba Medical Center
        • Principal Investigator:
          • Merav Lidar
        • Contact:
          • Phone Number: +97235304413
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Contact:
          • Phone Number: +97236973668
        • Principal Investigator:
          • Daphna Paran
  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
        • Contact:
          • Phone Number: +39303995487
        • Principal Investigator:
          • Franco Franceschini
      • Padova, Italy, 35100
        • Recruiting
        • Azienda Ospedaliera di Padova
        • Contact:
          • Phone Number: +39498214391
        • Principal Investigator:
          • Luca Iaccarino
      • Pisa, Italy, 56100
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Contact:
          • Phone Number: +39502218290
        • Principal Investigator:
          • Marta Mosca
      • Roma, Italy, 00161
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza
        • Contact:
          • Phone Number: +39649974660
        • Principal Investigator:
          • Fabrizio Conti
      • Roma, Italy, 00155
        • Recruiting
        • Università Campus Bio-Medico di Roma
        • Contact:
          • Phone Number: +39862434745
        • Principal Investigator:
          • Roberto Giacomelli
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Completed
        • Istituto Clinico Humanitas
    • Roma
      • Rome, Roma, Italy, 00151
        • Recruiting
        • Azienda Ospedaliera San Camillo Forlanini
        • Contact:
          • Phone Number: +39658704218
        • Principal Investigator:
          • Gian Domenico Sebastiani
    • Salerno
      • Scafati, Salerno, Italy, 84018
        • Recruiting
        • Ospedale M. Scarlato
        • Contact:
          • Phone Number: +39815356111
        • Principal Investigator:
          • Salvatore Scarpato
  • Japan
    • Aichi-Ken
      • Nagoya-shi, Aichi-Ken, Japan, 457-8510
        • Recruiting
        • JCHO Chukyo Hospital
      • Toyoake-shi, Aichi-Ken, Japan, 470-1192
        • Recruiting
        • Fujita Health University Hospital
    • Chiba-Ken
      • Chiba-shi, Chiba-Ken, Japan, 260-8712
        • Recruiting
        • NHO Chibahigashi National Hospital
      • Narashino-shi, Chiba-Ken, Japan, 275-8580
        • Recruiting
        • Chibaken Saiseikai Narashino Hospital
    • Fukuoka-Ken
      • Fukuoka-shi, Fukuoka-Ken, Japan, 810-8563
        • Recruiting
        • NHO Kyushu Medical Center
      • Fukuoka-shi, Fukuoka-Ken, Japan, 810-8539
        • Recruiting
        • KKR Hamanomachi Hospital
      • Kitakyushu-shi, Fukuoka-Ken, Japan, 807-8556
        • Recruiting
        • Hospital of the University of Occupational and Environmental Health, Japan
    • Hiroshima-Ken
      • Hiroshima-shi, Hiroshima-Ken, Japan, 734-8551
        • Recruiting
        • Hiroshima University Hospital
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-0004
        • Recruiting
        • Tonan Hospital
    • Hyogo-Ken
      • Himeji-shi, Hyogo-Ken, Japan, 670-8540
        • Recruiting
        • Japanese Red Cross Society Himeji Hospital
      • Kobe-shi, Hyogo-Ken, Japan, 650-0047
        • Recruiting
        • Kobe City Hospital Organization Kobe City Medical Center General Hospital
      • Kobe-shi, Hyogo-Ken, Japan, 650-0017
        • Recruiting
        • Kobe University Hospital
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Japan, 761-0793
        • Recruiting
        • Kagawa University Hospital
    • Kanagawa-Ken
      • Sagamihara-shi, Kanagawa-Ken, Japan, 252-0375
        • Recruiting
        • Kitasato University Hospital
      • Yokohama-shi, Kanagawa-Ken, Japan, 232-0024
        • Recruiting
        • Yokohama City University Medical Center
    • Kanagawa-ken
      • Kawasaki-shi, Kanagawa-ken, Japan, 216-8511
        • Recruiting
        • St. Mariana University Hospital
    • Kumamoto-Ken
      • Kumamoto-shi, Kumamoto-Ken, Japan, 861-8520
        • Recruiting
        • Japanese Red Cross Kumamoto Hospital
    • Miyagi-Ken
      • Sendai-shi, Miyagi-Ken, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
    • Osaka-Fu
      • Kawachinagano-shi, Osaka-Fu, Japan, 586-8521
        • Recruiting
        • NHO Osaka Minami Medical Center
      • Osaka-shi, Osaka-Fu, Japan, 530-8480
        • Recruiting
        • Tazuke-kofukai Medical Research Institute Kitano Hospital
      • Osakasayama-shi, Osaka-Fu, Japan, 589-8511
        • Recruiting
        • Kindai University Hospital
      • Takatsuki-shi, Osaka-Fu, Japan, 569-8686
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital
    • Saitama-Ken
      • Iruma-gun, Saitama-Ken, Japan, 350-0495
        • Recruiting
        • Saitama Medical University Hospital
    • Tokyo-To
      • Bunkyo-ku, Tokyo-To, Japan, 113-8519
        • Recruiting
        • Tokyo Medical And Dental University Hospital
      • Chuo-ku, Tokyo-To, Japan, 104-8560
        • Recruiting
        • St. Luke's International Hospital
      • Itabashi-ku, Tokyo-To, Japan, 173-8610
        • Recruiting
        • Nihon University Itabashi Hospital
      • Meguro-ku, Tokyo-To, Japan, 153-8515
        • Recruiting
        • Toho University Ohashi Medical Center
      • Ota-ku, Tokyo-To, Japan, 143-8541
        • Recruiting
        • Toho University Omori Medical Center
      • Shinjuku-ku, Tokyo-To, Japan, 160-8582
        • Recruiting
        • Keio University Hospital
      • Shinjuku-ku, Tokyo-To, Japan, 162-8655
        • Recruiting
        • Center Hospital of the National Center for Global Health and Medicine
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Recruiting
        • Amsterdam UMC, Locatie VUMC
        • Contact:
          • Phone Number: +31204444444
        • Principal Investigator:
          • Ronald van Vollenhoven
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • Universitair Medisch Centrum Groningen
        • Contact:
          • Phone Number: +31503616161
        • Principal Investigator:
          • Karina De Leeuw
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • UMC Utrecht
        • Contact:
          • Phone Number: +313188755050
        • Principal Investigator:
          • Maarten Limper
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Recruiting
        • Centro Reumatologico
        • Contact:
          • Phone Number: 7874471491
        • Principal Investigator:
          • Amarilis Perez De Jesus
  • Romania
      • Brasov, Romania, 500283
        • Recruiting
        • S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
        • Contact:
          • Phone Number: +40722530460
        • Principal Investigator:
          • Liliana Duca
      • Bucuresti, Romania, 014142
        • Recruiting
        • S.C Dental Health Care SRL
        • Principal Investigator:
          • Bogdan Horia Chicos
        • Contact:
          • Phone Number: +40745088514
      • Cluj-Napoca, Romania, 400006
        • Recruiting
        • Spitalul Clinic Judetean de Urgenta Cluj Napoca
        • Principal Investigator:
          • Simona Rednic
        • Contact:
          • Phone Number: +40264591942
      • Iasi, Romania, 700023
        • Recruiting
        • S.C.Centrul Medical Unirea SRL
        • Contact:
          • Phone Number: +40740063687
        • Principal Investigator:
          • Codrina Irena Mihaela Ancuta
      • Suceava, Romania, 720284
        • Recruiting
        • Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava
        • Contact:
          • Phone Number: +40745064950
        • Principal Investigator:
          • Iulia-Codruta Bran (Belibou)
      • Targu Mures, Romania, 540136
        • Recruiting
        • S.C Centrul Medical Unirea SRL
        • Contact:
          • Phone Number: +40725511508
        • Principal Investigator:
          • Monica Chis
  • Serbia
      • Belgrade, Serbia, 11080
        • Recruiting
        • Clinical Hospital Center Bezanijska kosa
        • Contact:
          • Phone Number: +381112095617
        • Principal Investigator:
          • Gordana Bogdanovic
      • 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:
          • Predrag Ostojic
        • Contact:
          • Phone Number: +381648833032
      • Niska Banja, Serbia, 18205
        • Recruiting
        • Institute of Treatment and Rehabilitation "Niska Banja"
        • Contact:
          • Phone Number: +38118502045
        • Principal Investigator:
          • Jovan Nedovic
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, E11 1NR
        • Recruiting
        • Whipps Cross University Hospital
        • Contact:
          • Phone Number: +442034165000
        • Principal Investigator:
          • Angela Pakozdi
      • London, Greater London, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's Hospital
        • Contact:
          • Phone Number: +44207188718854400
        • Principal Investigator:
          • David P DCruz
    • South Yorkshire
      • Doncaster, South Yorkshire, United Kingdom, DN2 5LT
        • Recruiting
        • Doncaster Royal Infirmary
        • Contact:
          • Phone Number: +441302644482
        • Principal Investigator:
          • Chee-Seng Yee
    • Staffordshire
      • Cannock, Staffordshire, United Kingdom, WS11 5XY
        • Recruiting
        • Cannock Chase Hospital
        • Contact:
          • Phone Number: +441543576449
        • Principal Investigator:
          • Thomas Sheeran
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama Birmingham
        • Principal Investigator:
          • Jose Enrique Rubio Mosquera
        • Contact:
          • Phone Number: 2059969784
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates, P.C.
        • Principal Investigator:
          • Areena Swarup
        • Contact:
          • Phone Number: 480-321-8580
    • California
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Valerius Medical Group
        • Contact:
          • Phone Number: 562-794-9801
        • Principal Investigator:
          • Nathaniel Neal
      • Whittier, California, United States, 90602
        • Recruiting
        • Medvin Clinical Research
        • Principal Investigator:
          • Tien-I Karleen Su
        • Contact:
          • Phone Number: 5627586600
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Completed
        • RASF - Clinical Research Center
      • Gainesville, Florida, United States, 32611
        • Recruiting
        • University of Florida Gainesville
        • Principal Investigator:
          • Michael R Bubb
        • Contact:
          • Phone Number: 352-273-5340
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine
        • Contact:
          • Phone Number: 3052438567
        • Principal Investigator:
          • Maria Fernanda Carpintero
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Clinical Research of West Florida, Inc.
        • Contact:
          • Phone Number: 813-870-1292
        • Principal Investigator:
          • Paul A Lunseth
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • The Emory Clinic Emory University
        • Contact:
          • Phone Number: 404-616-3640
        • Principal Investigator:
          • Sam S. Lim
      • Decatur, Georgia, United States, 30033
        • Completed
        • Jefrey Lieberman, M.D., P.C.
      • Gainesville, Georgia, United States, 30501
        • Recruiting
        • Arthritis Center of North Georgia
        • Contact:
          • Phone Number: 770-531-3711
        • Principal Investigator:
          • Brent A. Flickinger
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
          • Phone Number: 312-563-2800
        • Principal Investigator:
          • Meenakshi Jolly
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston University School of Medicine
        • Contact:
          • Phone Number: 617-358-9650
        • Principal Investigator:
          • Monica Crespo-Bosque
      • Worcester, Massachusetts, United States, 01605
        • Recruiting
        • University of Massachusetts
        • Contact:
          • Phone Number: 508-334-0221
        • Principal Investigator:
          • Jonathan Kay
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Recruiting
        • Saint Louis Rheumatology
        • Contact:
          • Phone Number: 314-646-0688
        • Principal Investigator:
          • Chad M. Ronholm
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Completed
        • Arthritis & Osteoporosis Associates, PA
    • New Mexico
      • Las Cruces, New Mexico, United States, 88011
        • Recruiting
        • Arthritis and Osteoporosis Associates of New Mexico
        • Contact:
          • Phone Number: 575-532-5934
        • Principal Investigator:
          • Arthur R. Synder
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • DJL Clinical Research, PLLC
        • Contact:
          • Phone Number: 7042479179
        • Principal Investigator:
          • Emily Jane Herron Box
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Carolina Arthritis Associates
        • Contact:
          • Phone Number: 9107621182
        • Principal Investigator:
          • Mark Daniel Harris
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati
        • Contact:
          • Phone Number: 5135592370
        • Principal Investigator:
          • Michael Edmund Luggen
      • Dayton, Ohio, United States, 45417
        • Recruiting
        • STAT Research
        • Principal Investigator:
          • Chacko Alappatt
        • Contact:
          • Phone Number: 937-887-9009
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • Recruiting
        • Piedmont Arthritis Clinic, P.A.
        • Contact:
          • Phone Number: 864-527-2307
        • Principal Investigator:
          • Richard Kim
      • Summerville, South Carolina, United States, 29486
        • Completed
        • Low Country Rheumatology, PA
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Recruiting
        • West Tennessee Research Institute
        • Contact:
          • Phone Number: 731-664-0002
        • Principal Investigator:
          • Jacob Aelion
    • Texas
      • Allen, Texas, United States, 75013
        • Completed
        • Office of John P. Lavery M.D., PA
      • Austin, Texas, United States, 78745
        • Recruiting
        • Tekton Research
        • Contact:
          • Phone Number: 512-388-5717
        • Principal Investigator:
          • Paul K Pickrell
      • Colleyville, Texas, United States, 76034
        • Recruiting
        • Precision Comprehensive Clinical Research Solutions
        • Contact:
          • Phone Number: 972-299-8399
        • Principal Investigator:
          • Uzma Syeda
      • Mesquite, Texas, United States, 75150
        • Completed
        • SouthWest Rheumatology Research, LLC
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • Sun Research Institute, LLC
        • Principal Investigator:
          • Leonel Reyes
        • Contact:
          • Phone Number: 210-227-4100
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • The University of Texas Health
        • Contact:
          • Phone Number: 210-450-9800
        • Principal Investigator:
          • Agustin Escalante
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Medical Center
        • Contact:
          • Phone Number: 206-386-2000
        • Principal Investigator:
          • Philip J Mease

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:

  • Participant must be diagnosed with SLE at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, at screening by a qualified physician.
  • Participant has a modified Systemic Lupus Erythematosus Disease Activity Index-200 (SLEDAI-2K) score ≥6 (excluding alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated).
  • Participant has a modified clinical SLEDAI-2K score ≥4 (excluding anti-dsDNA, low complement component 3 [C3] and/or complement component 4 [C4], alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated) and randomization.
  • Participant has BILAG-2004 grade A in ≥1 organ system or BILAG-2004 grade B in ≥2 organ systems at screening (adjudicated) and randomization.

  • Participants must be treated with one of the following background nonbiologic lupus SOC therapies, initiated ≥12 weeks prior to screening and at stable dose ≥4 weeks prior to randomization:

    1. Antimalarials as stand-alone treatment
    2. Antimalarial treatment in combination with OCS and/or a single immunosuppressant
    3. Treatment with OCS and/or a single immunosuppressant.

Key Exclusion Criteria:

  • History of or positive test result for human immunodeficiency virus (HIV).
  • Current hepatitis C infection (defined as positive hepatitis C virus [HCV] antibody and detectable HCV ribonucleic acid [RNA]).
  • Current hepatitis B infection (defined as positive for antibody to hepatitis B surface antigen [HBsAg] and/or positive for total antibody to hepatitis B core antigen [anti-HBc] with positive reflex HBV DNA).
  • History of severe herpes infection.
  • Presence of uncontrolled or New York Heart Association class III or IV congestive heart failure.
  • Active severe lupus nephritis where, in the opinion of the investigator, protocol-specified SOC is insufficient and use of a more aggressive therapeutic approach, such as adding intravenous (IV) cyclophosphamide and/or high-dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated; or urine protein-creatinine ratio >2.0 or severe chronic kidney disease (estimated glomerular filtration rate <30 milliliters per minute per 1.73 meter square [mL/min/1.73 m^2]) calculated using the abbreviated Modification of Diet in Renal Disease equation.
  • Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE skin lupus manifestation or drug-induced lupus.
  • History or current diagnosis of a clinically significant non-SLE-related vasculitis syndrome.
  • Active neuropsychiatric SLE.
  • Use of oral prednisone (or equivalent) above 20 mg/day.

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: Litifilimab High Dose
Participants who are receiving background nonbiologic lupus SOC therapy will receive high dose of litifilimab, subcutaneously (SC), every 4 weeks (Q4W), up to Week 48 with an additional dose at Week 2.
Drug: Litifilimab
Administered as specified in the treatment arm.
Other Names:
  • BIIB059
Experimental: Litifilimab Low Dose
Participants who are receiving background nonbiologic lupus SOC therapy will receive low dose of litifilimab, SC Q4W, up to Week 48 with an additional dose at Week 2.
Drug: Litifilimab
Administered as specified in the treatment arm.
Other Names:
  • BIIB059
Placebo Comparator: Placebo
Participants who are receiving background nonbiologic lupus SOC therapy will receive litifilimab-matching placebo, SC Q4W, up to Week 48 with an additional dose at Week 2.
Drug: Placebo
Administered as specified in the treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52
Time Frame: Week 52

An SRI-4 response is a composite endpoint defined by the following criteria:

  • Reduction from baseline of ≥4 points in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K).
  • No new organ system affected as defined by no new organ system with British Isles Lupus Assessment Group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with baseline.
  • No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point Physician's Global Assessment (PGA) - Visual Analog Scale (VAS).
  • No violation to protocol-specified medication rules.
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52
Time Frame: Week 52
Joint-50 response is 50% reduction in total active joint count from baseline. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts.
Week 52
Annualized Flare Rate Through Week 52
Time Frame: Up to Week 52
Annualized flare rate will be calculated as the total number of flares divided by the flare exposure time in days, and the ratio multiplied by 365.25.
Up to Week 52
Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response by Visit
Time Frame: Up to Week 52
The BILAG disease activity index evaluates SLE activity in number of organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows, BILAG A: severe disease activity; BILAG B: moderate disease activity; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved. BICLA is a composite endpoint defined as BILAG-2004 improvement, defined as all BILAG-2004 grade A at Baseline improved to grade B, C, or D, and all BILAG-2004 grade B at baseline improved to grade C or D, no BILAG-2004 worsening in other BILAG-2004 organ systems such that there are no new BILAG-2004 grade A or greater than 1 new BILAG-2004 grade B, no worsening in the SLEDAI-2K total score compared with Baseline, no worsening from Baseline in lupus disease activity defined by < 0.3-point increase on 3-point PGA-VAS and no violation to protocol-specified medication rules.
Up to Week 52
Percentage of Participants with Joint-50 Response by Visit
Time Frame: Up to Week 52
Joint-50 response is 50% reduction in total active joint count from baseline. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts.
Up to Week 52
Percentage of Participants with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-20, -50, -70, or -90 Response by Visit
Time Frame: Up to Week 52
Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-20, -50, -70 and -90 represent 20%, 50%, 70% or 90% improvement from baseline in CLASI-A score, respectively.
Up to Week 52
Time to First British Isles Lupus Activity Group-2004 (BILAG-2004) Severe Flare by Visit
Time Frame: Up to Week 52
BILAG-2004 severe flare is defined as an A score for items recorded as worse or new. BILAG-2004 is evaluated by scoring each item of a list of signs and symptoms given as 4 = new; 3 = worse; 2 = same; 1 = improving; 0 = not present; and ND = not done.
Up to Week 52
Percentage of Participants With Baseline OCS ≥10 mg/day Who Achieved ≤7.5 mg/day at Week 52
Time Frame: Week 52
Week 52
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Up to Week 52
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE is an AE that started or worsened in severity after the first dose of study treatment through 28 days after the last dose of study treatment or end of study (EOS) date, whichever comes earlier. An SAE is any untoward medical occurrence that at any dose results in death (a life-threatening event), in the view of the investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a birth defect, or is a medically important event.
Up to Week 52
Percentage of Participants Who Achieved an SRI-4 Response at Week 24
Time Frame: Week 24

An SRI-4 response is a composite endpoint defined by the following criteria:

  • Reduction from baseline of ≥4 points in SLEDAI-2K.
  • No new organ system affected as defined by no new organ system with BILAG-2004 grade A and no more than 1 new organ system with BILAG-2004 grade B compared with baseline.
  • No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA-VAS.
  • No violation to protocol-specified medication rules.
Week 24
Percentage of Participants with OCS ≥10 milligrams per day (mg/day) at Baseline Who Have OCS Reduction to ≤7.5 mg/day at Week 40, Which Is Sustained Through Week 52 with No Disease Worsening from Week 40 to Week 52
Time Frame: Week 40 up to Week 52
No worsening of the disease is defined as no new BILAG-2004 grade A or less than 2 new BILAG-2004 grade B since the last visit during the Week 40 to Week 52.
Week 40 up to Week 52
Percentage of Participants with a CLASI-A Score ≥10 at Baseline Who Achieved a 50% Improvement from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-50) Response at Week 16
Time Frame: Week 16
Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50 is 50% of improvement form baseline in CLASI-A.
Week 16
Change from Baseline in Physician's Global Assessment (PGA) - Visual Analog Scale (VAS) Score by Visit
Time Frame: Up to Week 52
The PGA is an investigator-administered assessment used to quantify disease activity and is measured using an anchored VAS. PGA asks the investigator to assess the participant's current disease activity from a score of 0 (none) to 3 (severe), with the assessment made relative to the most severe state of SLE.
Up to Week 52
Time to Onset of SRI-4 Response Sustained Through Week 52
Time Frame: Up to Week 52

An SRI-4 response is a composite endpoint defined by the following criteria:

  • Reduction from baseline of ≥4 points in SLEDAI-2K.
  • No new organ system affected as defined by no new organ system with BILAG-2004 grade A and no more than 1 new organ system with BILAG-2004 grade B compared with baseline.
  • No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA-VAS.
  • No violation to protocol-specified medication rules.
Up to Week 52
Percentage of Participants Who Achieved SRI-4, -5, or -6 Response by Visit
Time Frame: Up to Week 52

An SRI-4 response is a composite endpoint defined by the following criteria:

  • Reduction from baseline of ≥4 points in SLEDAI-2K.
  • No new organ system affected as defined by no new organ system with BILAG-2004 grade A and no more than 1 new organ system with BILAG-2004 grade B compared with baseline.
  • No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA-VAS.
  • No violation to protocol-specified medication rules. SRI-5 and SRI-6 are computed with a minimal five-point or six-point improvement in SLEDAI-2K being required, respectively.
Up to Week 52
Percentage of Participants with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-A Score of ≤1 by Visit
Time Frame: Up to Week 52
Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-A ≤1 represent the absolute score ≤1 in CLASI-A by visit.
Up to Week 52
Time to First Severe Flare as Defined by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI)
Time Frame: Up to Week 52
SFI severe flare is defined any of the following: change in SLEDAI instrument score to >12; or new or worse: central nervous system SLE; vasculitis; nephritis; myositis; platelets <60,000 per milliliter (/mL); or hemolytic anemia with hemoglobin <7 grams per deciliter (g/dL) or decrease in hemoglobin >3 g/dL and requiring: doubling prednisone dose; or increase to >0.5 milligrams per kilogram per day (mg/kg/day) or hospitalization; or increase in prednisone dose to >0.5 mg/kg/day; or new requirement for cyclophosphamide, azathioprine, methotrexate, or mycophenolate for SLE activity; or hospitalization for SLE activity; or increase in PGA score to >2.5.
Up to Week 52
Change from Baseline in Lupus-Specific Health-Related Quality-of-Life Questionnaire (LupusQoL) Score
Time Frame: Up to Week 52
The LupusQoL is a participant-reported, lupus-specific, health-related quality-of-life questionnaire (HRQoL) consisting of 34 items grouped in 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4 = never, 3 = occasionally, 2 = a good bit of the time, 1 = most of the time, and 0 = all the time. A LupusQoL score for each domain will be reported on a 0 to 100 scale, with greater values indicating better HRQoL.
Up to Week 52
Change from Baseline in Short Form Health Survey-36 (SF-36) Score
Time Frame: Up to Week 52
SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary (PCS) score of SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement.
Up to Week 52
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
Time Frame: Up to Week 52
FACIT-Fatigue is a participant-administered HRQoL questionnaire that evaluates participant's fatigue in the 5 broad categories: physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns. The level of fatigue is measured by questions assessed on a 5-point scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The responses for each item are added to obtain a total score which ranges from 0 to 52, with a higher score indicating less fatigue.
Up to Week 52
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
Time Frame: Up to Week 52
PHQ-9 is a participant-administered HRQoL questionnaire to screen for the presence and severity of depression. The PHQ-9 is a participant-reported outcome (PRO) that is used to measure depression in adults. It contains 9 questions. The PHQ-9 yields an overall severity score that can range from 0 to 27 with the following severity scores: 0- 4 = none; 5-9 = mild; 10-14 = moderate; 15-19 = moderate-to-severe; and 20-27 = severe.
Up to Week 52
Change from Baseline in Work Productivity and Activity Impairment (WPAI): Lupus Score
Time Frame: Up to Week 52
WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteeism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. Each score ranges from 0 to 100, with higher scores indicating greater impairment and less productivity.
Up to Week 52
Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)
Time Frame: Up to Week 52

LLDAS is a composite endpoint defined as:

  • SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and
  • No new features of lupus disease activity compared with the previous assessment; and
  • Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) PGA ≤ 1; and
  • Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and
  • Standard maintenance doses of immunosuppressive drugs and approved biological agents.
Up to Week 52
Percentage of Participants With Sustained LLDAS as Defined by the Number of Participants With ≥ 3, ≥ 5, and ≥ 7 Consecutive Visits in LLDAS up to and Including Week 52
Time Frame: Up to Week 52

LLDAS is a composite endpoint defined as:

  • SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and
  • No new features of lupus disease activity compared with the previous assessment; and
  • SELENA-SLEDAI PGA ≤ 1; and
  • Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and
  • Standard maintenance doses of immunosuppressive drugs and approved biological agents.
Up to Week 52
Percentage of Participants who Achieved LLDAS at Week 52
Time Frame: Week 52

LLDAS is a composite endpoint defined as:

  • SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and
  • No new features of lupus disease activity compared with the previous assessment; and
  • SELENA-SLEDAI PGA ≤ 1; and
  • Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and
  • Standard maintenance doses of immunosuppressive drugs and approved biological agents.
Week 52
Number of Participants with Antibodies to Litifilimab
Time Frame: Up to Week 52
Up to Week 52

Collaborators and Investigators

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

Sponsor

Biogen

Investigators

  • Study Director: Medical Director, Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

July 16, 2021

Primary Completion (Estimated)

September 18, 2025

Study Completion (Estimated)

March 5, 2026

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230LE304
  • 2023-505696-74 (Other Identifier: EU CTIS)

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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