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-1)

April 29, 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

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Box Hill Hospital
      • Footscray, Victoria, Australia, 3011
        • Completed
        • Footscray Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital
  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40150-150
        • Recruiting
        • Clínica SER da Bahia
        • Principal Investigator:
          • Mittermayer Barreto Santiago
        • Contact:
          • Phone Number: 5571988355001
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-370
        • Recruiting
        • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
        • Contact:
          • Phone Number: 5585991711566
        • Principal Investigator:
          • Vanessa Beatriz de Vasconcelos Marques
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 70200-730
        • Recruiting
        • L2IP - Instituto de Pesquisas Clínicas Ltda.
        • Principal Investigator:
          • Eduardo Freire Vasconcellos
        • Contact:
          • Phone Number: 556134454300
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055-450
        • Recruiting
        • CEDOES - Diagnóstico e Pesquisa
        • Contact:
          • Phone Number: 552721250223
        • Principal Investigator:
          • Valquiria Garcia Dinis
    • Mato Grosso
      • Cuiabá, Mato Grosso, Brazil, 78043-142
        • Recruiting
        • Oncovida - Centro de Onco-Hematologia de Mato Grosso
        • Principal Investigator:
          • Luiz Sergio Guedes Barbosa
        • Contact:
          • Phone Number: 5565999814014
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Recruiting
        • Santa Casa de Misericórdia de Belo Horizonte
        • Contact:
          • Phone Number: 3193259162
        • Principal Investigator:
          • Mariana Peixoto Guimaraes Ubirajara e Silva de Souza
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Recruiting
        • CMiP - Centro Mineiro de Pesquisa
        • Contact:
          • Phone Number: 553233128920
        • Principal Investigator:
          • Viviane Angelina de Souza
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • Recruiting
        • CETI - Centro de Estudos em Terapias Inovadoras Ltda.
        • Principal Investigator:
          • Sebastiao Cezar Radominski
        • Contact:
          • Phone Number: 554130223482
    • Rio Grande Do Sul
      • Lajeado, Rio Grande Do Sul, Brazil, 95900-000
        • Recruiting
        • Hospital Bruno Born
        • Principal Investigator:
          • Jussara Marilu Bohn
        • Contact:
          • Phone Number: 555137147500
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:
          • Phone Number: 555133598340
        • Principal Investigator:
          • Riccardo Machado Xavier
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
        • Recruiting
        • LMK Serviços Médicos S/S Ltda
        • Principal Investigator:
          • Mauro Waldemar Keiserman
        • Contact:
          • Phone Number: 555133205057
    • Sao Paulo
      • Sao Jose Rio Preto, Sao Paulo, Brazil, 15090-000
        • Recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
        • Contact:
          • Phone Number: 551732015054
        • Principal Investigator:
          • Mariana Alves Ferreira Martins
      • São Bernardo do Campo, Sao Paulo, Brazil, 09715-090
        • Recruiting
        • Centro Multidisciplinar de Estudos Clínicos - CEMEC
        • Contact:
          • Phone Number: 551123794095
        • Principal Investigator:
          • Anna Maura Ferreira Fernandes
      • São Paulo, Sao Paulo, Brazil, 04266-010
        • Recruiting
        • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
        • Contact:
          • Phone Number: 551122713450
        • Principal Investigator:
          • Flora Maria D'Andrea Marcolino
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Recruiting
        • DCC 'Sv. Georgi', EOOD
        • Principal Investigator:
          • Mariela Geneva-Popova
        • Contact:
          • Phone Number: 359898523128
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • UMHAT "Pulmed" OOD
        • Contact:
          • Phone Number: 359888204021
        • Principal Investigator:
          • Lyubomir Sapoundziev
      • Plovdiv, Bulgaria, 4003
        • Recruiting
        • UMHAT-Plovdiv AD
        • Contact:
          • Phone Number: 359878533483
        • Principal Investigator:
          • Ivan Goranov
      • Ruse, Bulgaria, 7002
        • Recruiting
        • DCC 1 - Ruse, EOOD
        • Principal Investigator:
          • Nadezhda Kapandjieva
        • Contact:
          • Phone Number: 359888411725
      • Sofia, Bulgaria, 1510
        • Recruiting
        • Medical Center Hera EOOD
        • Contact:
          • Phone Number: 359887828079
        • Principal Investigator:
          • Rositsa Svetoslavova Dacheva
      • Sofia, Bulgaria, 1431
        • Recruiting
        • DCC 'Alexandrovska', EOOD
        • Principal Investigator:
          • Delina Ivanova
        • Contact:
          • Phone Number: 359877891636
      • Sofia, Bulgaria, 1606
        • Recruiting
        • Military Medical Academy - MHAT - Sofia
        • Principal Investigator:
          • Boycho Oparanov
        • Contact:
          • Phone Number: 359888985531
      • Sofia, Bulgaria, 1612
        • Recruiting
        • UMHAT 'Sv. Ivan Rilski', EAD
        • Principal Investigator:
          • Rasho Rashkov
        • Contact:
          • Phone Number: 359899902901
  • Chile
      • Osorno, Chile, 5290000
        • Completed
        • Clinica Alemana de Osorno
      • Santiago, Chile, 7500710
        • Recruiting
        • BioMedica Research Group
        • Principal Investigator:
          • Elizabeth Jean Moreno Goio
        • Contact:
          • Phone Number: 56992323955
      • Santiago, Chile, 7500587
        • Recruiting
        • Enroll Spa
        • Contact:
          • Phone Number: 56964790949
        • Principal Investigator:
          • Anne Marie Chassin Trubert
      • Santiago, Chile, 7500000
        • Recruiting
        • Centro Medico Prosalud
        • Principal Investigator:
          • Irmgadt Annelise Goecke Sariego
        • Contact:
          • Phone Number: 56223780203
      • Santiago, Chile, 7500010
        • Recruiting
        • Interin
        • Contact:
          • Phone Number: 56229540252
        • Principal Investigator:
          • Lilian Andrea Soto Saez
      • Santiago, Chile, 7500571
        • Recruiting
        • CTR Estudios
        • Contact:
          • Phone Number: 56993459808
        • Principal Investigator:
          • Ivan Antonia Gonzalez Abarzua
      • Santiago, Chile, 7510186
        • Recruiting
        • SOMEAL
        • Contact:
          • Phone Number: 56222442430
        • Principal Investigator:
          • Marta Aliste Silva
  • France
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • Recruiting
        • Groupe Hospitalier Pellegrin - Hôpital Pellegrin
        • Contact:
          • Phone Number: 33556795679
        • Principal Investigator:
          • Christophe Richez
    • Herault
      • Montpellier Cedex 5, Herault, France, 34295
        • Recruiting
        • Hopital Lapeyronie
        • Contact:
          • Phone Number: 33619690761
        • Principal Investigator:
          • Jaques Morel
    • Puy De Dome
      • Clermont-Ferrand cedex 1, Puy De Dome, France, 63003
        • Recruiting
        • CHU Clermont Ferrand - Hopital Gabriel Montpied
        • Principal Investigator:
          • Marc Andre
        • Contact:
          • Phone Number: 33473752124
  • Greece
      • Athens, Greece, 11527
        • Recruiting
        • General Hospital of Athens Laiko
        • Principal Investigator:
          • Panayiotis Vlachogiannopoulos
        • Contact:
          • Phone Number: 302107462663
      • Athens, Greece, 11521
        • Recruiting
        • NNA Hospita;
        • Contact:
          • Phone Number: 302107261705
        • Principal Investigator:
          • Gkikas Katsifis
      • Athens, Greece, 12462
        • Recruiting
        • University General Hospital 'Attikon'
        • Contact:
          • Phone Number: 302105831990
        • Principal Investigator:
          • Dimitrios Boumpas
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Recruiting
        • Dong-A University Hospital
      • Incheon, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republic of, 5505
        • Recruiting
        • Asan Medical Center
      • Seoul, Korea, Republic of, 4763
        • Recruiting
        • Hanyang University Seoul Hospital
      • Seoul, Korea, Republic of, 5030
        • Recruiting
        • Konkuk University Medical Center
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Recruiting
        • Ajou University Hospital
  • Mexico
      • Chihuahua, Mexico, 31000
        • Recruiting
        • Investigacion y Biomedicina de Chihuahua, S.C.
        • Contact:
          • Phone Number: 5216141961278
        • Principal Investigator:
          • Cesar Francisco Pacheco Tena
      • Durango, Mexico, 34080
        • Recruiting
        • Centro de Investigacion y Atencion Integral Durango CIAID
        • Contact:
          • Phone Number: 526188103249
        • Principal Investigator:
          • Enrique Ortiz Jimenez
    • Distrito Federal
      • Ciudad de México, Distrito Federal, Mexico, 6700
        • Recruiting
        • Clinstile, S.A. de C.V.
        • Contact:
          • Phone Number: 525552561496
        • Principal Investigator:
          • Favio Edmundo Enriquez Sosa
      • Mexico, Distrito Federal, Mexico, 3720
        • Recruiting
        • Centro de Investigacion Clínica GRAMEL S.C
        • Principal Investigator:
          • Luis Javier Jara Quezada
        • Contact:
          • Phone Number: 525544274848
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44959
        • Recruiting
        • Centro de investigacion medica y reumatologia
        • Principal Investigator:
          • Jorge Enrique Aguilar Arreola
        • Contact:
          • Phone Number: 523333910401
      • Guadalajara, Jalisco, Mexico, 44130
        • Recruiting
        • Diseno y Planeacion en Investigacion Medica S.C.
        • Principal Investigator:
          • Jorge Enrique Aguilar Arreola
        • Contact:
          • Phone Number: 523333910401
      • Guadalajara, Jalisco, Mexico, 44650
        • Recruiting
        • Clinica de Investigacion en Reumatologia y Obesidad S.C.
        • Contact:
          • Phone Number: 523339521832
        • Principal Investigator:
          • Sergio Duran Barragan
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62448
        • Recruiting
        • Consultorio Privado Dr. Miguel Cortes Hernandez
        • Principal Investigator:
          • Miguel Cortes Hernandez
        • Contact:
          • Phone Number: 527773137932
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
        • Principal Investigator:
          • Diana Elsa Flores Alvarado
        • Contact:
          • Phone Number: 528180485219
    • Yucatán
      • Merida, Yucatán, Mexico, 97070
        • Recruiting
        • Medical Care & Research SA de CV
        • Contact:
          • Phone Number: 529993226891
        • Principal Investigator:
          • Aaron Alejandro Barrera Rodriguez
      • Merida, Yucatán, Mexico, 97000
        • Recruiting
        • Centro Peninsular de Investigacion Clinica, SCP
        • Contact:
          • Phone Number: 529992863586
        • Principal Investigator:
          • Francisco Avila Zapata
  • Philippines
      • Davao City, Philippines, 8000
        • Recruiting
        • Davao Doctors Hospital
      • Iloilo, Philippines, 5000
        • Recruiting
        • The Medical City Iloilo
      • Lipa City, Philippines, 4217
        • Recruiting
        • Mary Mediatrix Medical Center
      • Mabalacat, Pampanga, Philippines, 2023
        • Recruiting
        • The Medical City Clark
      • Manila, Philippines, 1000
        • Recruiting
        • Manila Doctors Hospital
      • Manila, Philippines, 1000
        • Recruiting
        • Philippine General Hospital
      • Manila, Philippines, 1000
        • Recruiting
        • Medical Center Manila
      • Quenzon City, Philippines, 1102
        • Recruiting
        • St. Luke's Medical Center
      • Quezon City, Metro Manila, Philippines, 1118
        • Recruiting
        • Far Eastern University - Dr. Nicanor Reyes Medical Foundation
  • Poland
      • Bialystok, Poland, 15-707
        • Recruiting
        • Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
        • Principal Investigator:
          • Izabela Domyslawska
        • Contact:
          • Phone Number: 48518630640
      • Bydgoszcz, Poland, 85-605
        • Recruiting
        • Centrum Medyczne Intercor Sp. z o.o
        • Contact:
          • Phone Number: 48601644770
        • Principal Investigator:
          • Piotr Ligocki
      • Bydgoszcz, Poland, 87-100
        • Recruiting
        • Szpital Uniwersytecki nr 2 im.dr J. Biziela
        • Principal Investigator:
          • Iwona Dankiewicz-Fares
        • Contact:
          • Phone Number: 48535557777
      • Bytom, Poland, 41-902
        • Recruiting
        • Nzoz Bif-Med
        • Contact:
          • Phone Number: 48508270636
        • Principal Investigator:
          • Hanna Mastalerz
      • Krakow, Poland, 30-363
        • Recruiting
        • Centrum Medyczne Plejady
        • Principal Investigator:
          • Magdalena Celinska Lowenhoff
        • Contact:
          • Phone Number: 48502662186
      • Krakow, Poland, 30-727
        • Recruiting
        • Pratia MCM Krakow
        • Principal Investigator:
          • Mariusz Korkosz
        • Contact:
          • Phone Number: 48602454689
      • Krakow, Poland, 31-023
        • Recruiting
        • Centrum Medyczne All-Med
        • Principal Investigator:
          • Grazyna Pulka
        • Contact:
          • Phone Number: 48608623915
      • Lublin, Poland, 20-607
        • Recruiting
        • Reumed Spolka z o.o.
        • Contact:
          • Phone Number: 48502238777
        • Principal Investigator:
          • Marcin Mazurek
      • Malbork, Poland, 82-200
        • Recruiting
        • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
        • Contact:
          • Phone Number: 48731085885
        • Principal Investigator:
          • Agnieszka Bielewicz-Zielinska
      • Warszawa, Poland, 00-874
        • Recruiting
        • MICS Centrum Medyczne Warszawa
        • Contact:
          • Phone Number: 48608552294
        • Principal Investigator:
          • Katarzyna Romanowska Prochnicka
      • Wroclaw, Poland, 53-224
        • Recruiting
        • Niepubliczny Zakład Opieki Zdrowotnej 'Biogenes' Sp. z o.o.
        • Contact:
          • Phone Number: 48717343300
        • Principal Investigator:
          • Piotr Wiland
  • Russian Federation
      • Kemerovo, Russian Federation, 650070
        • Recruiting
        • LLC 'Medical Center' Revma-Med '
        • Contact:
          • Phone Number: 79039094411
        • Principal Investigator:
          • Svetlana Anatolyevna Polyakova
      • Moscow, Russian Federation, 105554
        • Recruiting
        • Olla-Med, Llc
        • Contact:
          • Phone Number: 74996143522
        • Principal Investigator:
          • Daria Aleksandrovna Kusevich
      • Orenburg, Russian Federation, 460018
        • Recruiting
        • SBIH 'Orenburg Regional Clinical Hospital'
        • Contact:
          • Phone Number: 73532776103
        • Principal Investigator:
          • Olga Viktorovna Bugrova
  • Spain
      • Barcelona, Spain, 8035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Phone Number: 34934894171
        • Principal Investigator:
          • Josefina Cortes Hernandez
      • Granada, Spain, 18016
        • Recruiting
        • Hospital Universitario San Cecilio
        • Principal Investigator:
          • Jose Luis Callejas Rubio
        • Contact:
          • Phone Number: 3495840511
      • Sevilla, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Phone Number: 34954782286
        • Principal Investigator:
          • Francisco Javier Toyos Saenz de Miera
      • Sevilla, Spain, 41010
        • Recruiting
        • Hospital Quironsalud Infanta Luisa
        • Principal Investigator:
          • Juan Miguel Sanchez Burson
        • Contact:
          • Phone Number: 34954001876
      • Valencia, Spain, 46017
        • Recruiting
        • Hospital Universitario Dr. Peset
        • Principal Investigator:
          • Juan Jose Alegre Sancho
        • Contact:
          • Phone Number: 34961622372
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Principal Investigator:
          • Ricardo Blanco Alonso
        • Contact:
          • Phone Number: 34690695711
  • Sweden
      • Stockholm, Sweden, SE-171 76
        • Recruiting
        • Karolinska Universitetssjukhuset Solna
        • Contact:
          • Phone Number: 46851776955
        • Principal Investigator:
          • Iva Gunnarsson
      • Uppasala, Sweden, 75185
        • Recruiting
        • Akademiska Sjukhuset
        • Contact:
          • Phone Number: 46186110000
        • Principal Investigator:
          • Dag Leonard
      • Örebro, Sweden, 70185
        • Recruiting
        • Universitetssjukhuset Örebro
        • Contact:
          • Phone Number: 46196021000
        • Principal Investigator:
          • Ioannis Parodis
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
      • Taoyuan County, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital,Linkou
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Wallace Rheumatic Study Center
        • Contact:
          • Phone Number: 310-360-9197
        • Principal Investigator:
          • Daniel J Wallace
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Contact:
          • Phone Number: 323-442-1963
        • Principal Investigator:
          • William Stohl
      • Mission Hills, California, United States, 91345
        • Recruiting
        • Providence Facey Medical Foundation
        • Principal Investigator:
          • Sue Chung
        • Contact:
          • Phone Number: 818-869-7067
      • San Diego, California, United States, 92103
        • Recruiting
        • University of California San Diego School of Medicine
        • Contact:
          • Phone Number: 858-246-2382
        • Principal Investigator:
          • Arthur Francis Kavanaugh
      • Upland, California, United States, 91786
        • Recruiting
        • Inland Rheumatology Clinical Trials, Inc.
        • Contact:
          • Phone Number: 909-296-8700
        • Principal Investigator:
          • Eric Cheng-Jer Lee
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Contact:
          • Phone Number: 303-724-7607
        • Principal Investigator:
          • Christopher C Striebich
    • District of Columbia
      • Washington, District of Columbia, United States, 20007-2113
        • Recruiting
        • Georgetown University Hospital-Medstar
        • Contact:
          • Phone Number: 202-444-6200
        • Principal Investigator:
          • Verginia D. Steen
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • Arthritis & Rheumatic Disease Specialties
        • Principal Investigator:
          • Norman Gaylis
        • Contact:
          • Phone Number: 305-932-4162
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Clinical Research of West Florida - Corporate
        • Contact:
          • Phone Number: 727-466-0078
        • Principal Investigator:
          • Robert W. Levin
      • Coral Springs, Florida, United States, 33065
        • Recruiting
        • Believe Clinical Trials
        • Contact:
          • Phone Number: 813-333-5080
        • Principal Investigator:
          • Conrad Ziembinski
      • DeBary, Florida, United States, 32713
        • Recruiting
        • Omega Research Consultants
        • Contact:
          • Phone Number: 386-668-4202
        • Principal Investigator:
          • Luis Ramos
      • Fort Lauderdale, Florida, United States, 33334
        • Completed
        • Centre for Rheumatology, Immunology and Arthritis
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • GNP Research at Mark Jaffe, MD
        • Principal Investigator:
          • Mark Jaffe
        • Contact:
          • Phone Number: 954-441-9995
      • Margate, Florida, United States, 33063
        • Recruiting
        • Life Clinical Trials
        • Contact:
          • Phone Number: 954-669-1052
        • Principal Investigator:
          • Jigar Shah
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Charisma Medical and Research Center
        • Contact:
          • Phone Number: 305-244-7639
        • Principal Investigator:
          • Marimer Rensoli Velazquez
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Rheumatology Associates of Central Florida
        • Principal Investigator:
          • Pamela G Freeman
        • Contact:
          • Phone Number: 4078594540115
      • Tampa, Florida, United States, 33613
        • Completed
        • AdventHealth Medical Group
    • Michigan
      • Flint, Michigan, United States, 48504
        • Recruiting
        • AA MRC LLC Ahmed Arif Medical Research Center
        • Principal Investigator:
          • Ali A. Karrar
        • Contact:
          • Phone Number: 810-694-0082
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
          • Phone Number: 314-977-6163
        • Principal Investigator:
          • Reema H. Syed
    • New York
      • Brooklyn, New York, United States, 11201
        • Recruiting
        • Joseph S. and Diane H. Steinberg Ambulatory Care Center
        • Contact:
          • Phone Number: 929-455-2399
        • Principal Investigator:
          • David Harry Goddard
      • New Hyde Park, New York, United States, 11042-1118
        • Recruiting
        • Northwell Health Center for Advanced Medicine
        • Contact:
          • Phone Number: 516-562-3838
        • Principal Investigator:
          • Meggan C. Mackay
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Contact:
          • Phone Number: 585-275-1632
        • Principal Investigator:
          • Jennifer H Anolik
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical Center
        • Contact:
          • Phone Number: 315-464-4194
        • Principal Investigator:
          • Andres Perl
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Completed
        • Joint and Muscle Research Institute
      • Greensboro, North Carolina, United States, 27405
        • Completed
        • Medication Management, LLC
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
          • Phone Number: 610-931-7197
        • Principal Investigator:
          • Rupak Thapa
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • Paramount Medical Research & Consulting, LLC
        • Contact:
          • Phone Number: 440-891-9395
        • Principal Investigator:
          • Isam Abdulkader Diab
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Ramesh C Gupta, MD
        • Contact:
          • Phone Number: 901-681-9670
        • Principal Investigator:
          • Ramesh Chandra Gupta
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Phone Number: 615-936-4072
        • Principal Investigator:
          • Narender Annapureddy
    • Texas
      • Colleyville, Texas, United States, 76034-5913
        • Recruiting
        • Precision Comprehensive Clinical Research Solution
        • Principal Investigator:
          • Dhiman Basu
        • Contact:
          • Phone Number: 972-299-8399
      • Houston, Texas, United States, 77099
        • Recruiting
        • Pioneer Research Solutions, Inc.
        • Contact:
          • Phone Number: 713-333-9323
        • Principal Investigator:
          • Asif Cochinwala
      • Humble, Texas, United States, 77346
        • Recruiting
        • Accurate Clinical Research, Inc.
        • Contact:
          • Phone Number: 281-481-8557
        • Principal Investigator:
          • Philip Alan Waller
      • Stafford, Texas, United States, 77477
        • Recruiting
        • Accurate Clinical Research
        • Contact:
          • Phone Number: 281-422-7179
        • Principal Investigator:
          • Sabeen Najam
      • The Woodlands, Texas, United States, 77382
        • Recruiting
        • Advanced Rheumatology of Houston
        • Principal Investigator:
          • Tamar Brionez
        • Contact:
          • Phone Number: 832-452-7249
      • Webster, Texas, United States, 77598
        • Recruiting
        • CLS Research Ctr, PLLC
        • Contact:
          • Phone Number: 281-724-8184
        • Principal Investigator:
          • Abdelnaser Elkhalili
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Contact:
          • Phone Number: 206-685-9950
        • Principal Investigator:
          • Kwanghoon Han

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 systemic lupus erythematosus (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-2000 (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.

  • Participant 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 hepatitis antibody to 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 is indicated, such as adding 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 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.
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

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

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 Who Achieved an SRI-4 Response at Week 24
Time Frame: Week 24

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 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 PGA -VAS.
  • No violation to protocol-specified medication rules.
Week 24
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
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 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 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 from baseline in CLASI-A.
Week 16
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
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. The 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
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
Time to Onset of SRI-4 Response Sustained Through Week 52
Time Frame: Up to Week 52

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 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 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

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 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 PGA -VAS.
  • No violation to protocol-specified medication rules. The 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 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
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 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
Time to First Severe Flare as defined by the 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
Percentage of Participants With Baseline OCS ≥10 mg/day Who Achieved ≤7.5 mg/day at Week 52
Time Frame: Week 52
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
The SF-36 determines participant's 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 the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the 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
The 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
The 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. Presenteesism (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 numbers indicating greater impairment and less productivity
Up to 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 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)

May 25, 2021

Primary Completion (Estimated)

March 28, 2025

Study Completion (Estimated)

September 12, 2025

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Estimated)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230LE303
  • 2023-505695-30 (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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