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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
Sponsor: Biogen
Summary
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), the British Isles Lupus Activity Group-2004 index (BILAG-2004), and the BILAG-BASED Combined Lupus Assessment (BICLA), among others. 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
548
Start Date
2021-05-25
Completion Date
2027-03-16
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
Litifilimab
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Locations (164)
Tilda Research Birmingham
Homewood, Alabama, United States
Wallace Rheumatic Study Center
Beverly Hills, California, United States
University of Southern California
Los Angeles, California, United States
Providence Facey Medical Foundation
Mission Hills, California, United States
University of California San Diego School of Medicine
San Diego, California, United States
SCLA Management
Thousand Oaks, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Georgetown University Hospital-Medstar
Washington D.C., District of Columbia, United States
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States
Highlands Rheumatology
Avon Park, Florida, United States
Clinical Research of West Florida - Corporate
Clearwater, Florida, United States
Believe Clinical Trials
Coral Springs, Florida, United States
Omega Research Consultants
DeBary, Florida, United States
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, United States
GNP Research at Mark Jaffe, MD
Hollywood, Florida, United States
Life Clinical Trials
Margate, Florida, United States
Charisma Medical and Research Center
Miami Lakes, Florida, United States
Rheumatology Associates of Central Florida
Orlando, Florida, United States
AdventHealth Medical Group
Tampa, Florida, United States
Vantage Clinical Trials
Tampa, Florida, United States
Rheumatology care of Georgia
Kennesaw, Georgia, United States
Atlanta Research Center for Rheumatology LLC
Marietta, Georgia, United States
Accurate Clinical Research Inc.
Lake Charles, Louisiana, United States
AA MRC LLC Ahmed Arif Medical Research Center
Flint, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Renown Medical Group
Reno, Nevada, United States
Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York, United States
Northwell Health Center for Advanced Medicine
New Hyde Park, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
SUNY Upstate Medical Center
Syracuse, New York, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, United States
Medication Management, LLC
Greensboro, North Carolina, United States
OnSite Clinical Solutions, LLC - Charlotte
Salisbury, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Ramesh C Gupta, MD
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
PrimeCare 360
Allen, Texas, United States
Precision Comprehensive Clinical Research Solution
Colleyville, Texas, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, United States
Arthritis Care Texas
Corpus Christi, Texas, United States
Prolato Clinical Research Center
Houston, Texas, United States
Accurate Clinical Management LLC
Houston, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
Accurate Clinical Research, Inc.
Humble, Texas, United States
Accurate Clinical Research
Stafford, Texas, United States
Fort Bend Rheumatology Associates
Sugar Land, Texas, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, United States
CLS Research Ctr, PLLC
Webster, Texas, United States
University of Washington
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Footscray Hospital
Footscray, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza, Ceará, Brazil
CEDOES - Diagnóstico e Pesquisa
Vitória, Espírito Santo, Brazil
Clínica SER da Bahia
Salvador, Estado de Bahia, Brazil
L2IP - Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil
Oncovida - Centro de Onco-Hematologia de Mato Grosso
Cuiabá, Mato Grosso, Brazil
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
CMiP - Centro Mineiro de Pesquisa
Juiz de Fora, Minas Gerais, Brazil
CETI - Centro de Estudos em Terapias Inovadoras Ltda.
Curitiba, Paraná, Brazil
Hospital Bruno Born
Lajeado, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
LMK Serviços Médicos S/S Ltda
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Sao Jose Rio Preto, São Paulo, Brazil
Centro Multidisciplinar de Estudos Clínicos - CEMEC
São Bernardo do Campo, São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
São Paulo, São Paulo, Brazil
A2Z Clinical Centro Avancado de Pesquisa Clinica
Valinhos, São Paulo, Brazil
RDSS Ricardo Diaz Scientific Solution
São Paulo, Brazil
DCC 'Sv. Georgi', EOOD
Plovdiv, Bulgaria
UMHAT "Pulmed" OOD
Plovdiv, Bulgaria
UMHAT-Plovdiv AD
Plovdiv, Bulgaria
DCC 1 - Ruse, EOOD
Rousse, Bulgaria
DCC 'Alexandrovska', EOOD
Sofia, Bulgaria
Medical Center Hera EOOD
Sofia, Bulgaria
Military Medical Academy - MHAT - Sofia
Sofia, Bulgaria
UMHAT 'Sv. Ivan Rilski', EAD
Sofia, Bulgaria
Clinica Alemana de Osorno
Osorno, Chile
Centro Medico Prosalud
Santiago, Chile
Interin
Santiago, Chile
CTR Estudios
Santiago, Chile
Enroll Spa
Santiago, Chile
BioMedica Research Group
Santiago, Chile
CeCim Biocinetic
Santiago, Chile
Clinical Research Chile SpA.
Valdivia, Chile
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
Bordeaux, Gironde, France
Hopital Lapeyronie
Montpellier, Herault, France
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, Puy De Dome, France
NNA Hospita;
Athens, Greece
General Hospital of Athens Laiko
Athens, Greece
University General Hospital 'Attikon'
Athens, Greece
Diseno y Planeacion en Investigacion Medica S.C.
Guadalajara, Jalisco, Mexico
Centro de Investigacion Farmaceutica Especializada de Occidente S.C
Guadalajara, Jalisco, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, Mexico
Centro de investigacion medica y reumatologia
Guadalajara, Jalisco, Mexico
Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
Mexico City, Mexico City, Mexico
Centro de Investigacion Clínica GRAMEL S.C
Mexico City, Mexico City, Mexico
Clinstile, S.A. de C.V.
Mexico City, Mexico City, Mexico
Consultorio Privado Dr. Miguel Cortes Hernandez
Cuernavaca, Morelos, Mexico
Accelerium S. de R.L. de C.V.
Monterrey, Nuevo León, Mexico
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
Centro Peninsular de Investigacion Clinica, SCP
Mérida, Yucatán, Mexico
Unidad de Atencion Medica e Investigacion en Salud S.C.
Mérida, Yucatán, Mexico
Medical Care & Research SA de CV
Mérida, Yucatán, Mexico
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua City, Mexico
Centro de Investigacion y Atencion Integral Durango CIAID
Durango, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, Mexico
Hogar Clínica San Juan de Dios - Arequipa
Arequipa, Peru
Centro de Investigacion Clinica Immunoreumatologioa
Lima, Peru
Hospital Nacional Edgardo Rebagliati Martins
Lima, Peru
HMA - Hospital Maria Auxiliadora
Lima, Peru
Invest Clinicas Sac Inst de Ginecologia y Reproduccion
Lima, Peru
Chong Hua Hospital
Cebu City, Philippines
Ospital Ng Makati
City of Taguig, Philippines
Davao Doctors Hospital
Davao City, Philippines
The Medical City Iloilo
Iloilo City, Philippines
Mary Mediatrix Medical Center
Lipa City, Philippines
The Medical City Clark
Mabalacat, Pampanga, Philippines
Manila Doctors Hospital
Manila, Philippines
Medical Center Manila
Manila, Philippines
Philippine General Hospital
Manila, Philippines
Jose R. Reyes Memorial Medical Center
Manila, Philippines
St. Luke's Medical Center
Quenzon City, Philippines
Far Eastern University - Dr. Nicanor Reyes Medical Foundation
Quezon City, Metro Manila, Philippines
Lorma Medical Center
San Fernando City, La Union, Philippines
Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, Poland
Centrum Medyczne Intercor Sp. z o.o
Bydgoszcz, Poland
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, Poland
Nzoz Bif-Med
Bytom, Poland
Malopolskie Badania Kliniczne
Krakow, Poland
Centrum Medyczne Plejady
Krakow, Poland
Pratia MCM Krakow
Krakow, Poland
Centrum Medyczne All-Med
Krakow, Poland
Reumed Spolka z o.o.
Lublin, Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
Malbork, Poland
Twoja Przychodnia NCM
Nowa Sól, Poland
Prywatna Praktyka Lekarska prof Pawel Hrycaj
Poznan, Poland
Przychodnia Care Access Warszawa
Warsaw, Poland
MICS Centrum Medyczne Warszawa
Warsaw, Poland
Niepubliczny Zakład Opieki Zdrowotnej 'Biogenes' Sp. z o.o.
Wroclaw, Poland
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Dong-A University Hospital
Busan, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Rio Hortega
Valladolid, Cantabria, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario San Cecilio
Granada, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Quironsalud Infanta Luisa
Seville, Spain
Hospital Universitario Dr. Peset
Valencia, Spain
Universitetssjukhuset Orebro
Örebro, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, Sweden
Akademiska Sjukhuset
Uppasala, Sweden
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
Chang Gung Memorial Hospital,Linkou
Taoyuan, Taiwan