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A Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and it's Effects on Symptoms in Adults With Systemic Lupus Erythematosus (SLE)
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 adults who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. This is an extension study of 230LE303 and 230LE304 (TOPAZ-1 and TOPAZ-2). It will include participants who completed the treatment periods of either one of those parent studies. The main goal of the study is to learn more about the long-term safety of litifilimab in adults. The main question researchers want to answer is: \- How many participants have adverse events and serious adverse events during the study? Adverse events are health problems that may or may not be caused by the study drug. Researchers will also learn about: * The effect of litifilimab on controlling symptoms of SLE and lowering its activity. * How participants' immune systems respond to litifilimab. * The effect of litifilimab on the quality of life of participants. The study will be done as follows: * This study begins when the participant has finished 1 of the parent studies (either 230LE303 or 230LE304). * Participants who were getting either a high or low dose of litifilimab in either parent study will continue getting the same doses. * Participants who were getting the placebo in the parent studies will be randomized to get either a high or low dose of litifilimab. * Neither the researchers nor the participants will know which doses of litifilimab the participants are getting. * All participants will get litifilimab as injections under the skin once every 4 weeks. The treatment period will last up to 260 weeks. Participants may continue to take their standard of care medications. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 73 study visits. At these visits, the study doctor will do tests to check the participants' overall health, including the status of their SLE symptoms. They will also measure the participants' height, weight, and vital signs and collect blood and urine samples. Participants will also complete questionnaires or answer questions about how they are feeling and about their daily lives. * Each participant will be in the study for up to 284 weeks. Optional Substudy: * Some participants may be invited to join an optional "substudy" after being in the main study for at least 4 months. * This substudy will test a new injector device for delivering litifilimab. The injector device is an automatic device that delivers the full dose in 1 injection without needing to push a plunger. * Researchers will learn more about the safety of the injector device and how the body reacts to it. This will be compared to the current prefilled syringe method. * The substudy will last up to 3 months and will include about 120 participants.
Official title: A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
864
Start Date
2022-06-10
Completion Date
2032-05-03
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
Litifilimab
Administered as specified in the treatment arm.
Litifilimab-matching placebo
Administered as specified in the treatment arm.
Locations (214)
Arizona Arthritis & Rheumatology Associates, P.C.
Phoenix, Arizona, United States
Wallace Rheumatic Study Center
Beverly Hills, California, United States
Care Access Research - Huntington Beach
Huntington Beach, California, United States
Providence Facey Medical Foundation
Mission Hills, California, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States
University of Colorado Denver
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 Research Institute
Avon Park, Florida, United States
Clinical Research of West Florida - Corporate
Clearwater, Florida, United States
GNP Research at Mark Jaffe, MD
Cooper City, Florida, United States
Omega Research Consultants
DeBary, Florida, United States
Life Clinical Trials
Margate, Florida, United States
HMD Research, LLC
Orlando, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
AdventHealth Medical Group
Tampa, Florida, United States
Arthritis Center of North Georgia
Gainesville, Georgia, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
AA MRC LLC Ahmed Arif Medical Research Center
Flint, Michigan, United States
Precision Comprehensive Clinical Research Solutions
Rochester Hills, Michigan, United States
Saint Louis Rheumatology
St Louis, Missouri, United States
NYU Langone Brooklyn
Brooklyn, New York, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States
Onyx Clinical Research, LLC
Salisbury, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Ramesh C Gupta, MD
Memphis, Tennessee, United States
Arthritis & Rheumatology Research Institute
Allen, Texas, United States
Tekton Research - PARENT
Austin, Texas, United States
Accurate Clinical Research
Baytown, Texas, United States
Precision Comprehensive Clinical Research Solution
Colleyville, Texas, United States
Prolato Clinical Research Center
Houston, Texas, United States
Accurate Clinical Research, Inc.
Humble, Texas, United States
R and H Clinical Research
Katy, Texas, United States
Sun Research Institute, LLC
San Antonio, Texas, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Organizacion Medica de Investigacion (OMI)
CABA, Buenos Aires, Argentina
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Policlìnica Red Omip S.A - Ensayos Clinicos GC
Mar del Plata, Buenos Aires, Argentina
Centro Dermatologico Schejtman
San Miguel, Buenos Aires, Argentina
APRILLUS Asistencia e Investigacion
Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Centro Medico Barrio Parque
Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Consultorio Alto Dorrego
Villa Nueva, Mendoza Province, Argentina
Instituto CAICI
Rosario, Santa Fe Province, Argentina
Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
San Miguel de Tucumán, Tucumán Province, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Tucumán Province, Argentina
Investigaciones Clinicas Tucuman
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital Italiano de La Plata
Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes
Buenos Aires, Argentina
Cenemar SRL
Buenos Aires, Argentina
Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
Ciudad Autonoma Buenos Aires, Argentina
STAT Research S.A.
Ciudad Autonoma Buenos Aires, Argentina
Sanatorio Allende
Córdoba, Argentina
Instituto de Reumatologia
Mendoza, Argentina
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
San Juan, Argentina
Centre Hospitalier Universitaire de Liege
Liège, Belgium
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
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
Santo Ângelo, Mato Grosso, Brazil
Santa Casa de Misericordia 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 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
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose 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
CPCLIN - Centro de Pesquisas Clinicas
São Paulo, Brazil
RDSS Ricardo Diaz Scientific Solution
São Paulo, Brazil
MC Artmed OOD
Plovdiv, Bulgaria
UMHAT "Pulmed" OOD
Plovdiv, Bulgaria
UMHAT-Plovdiv AD
Plovdiv, Bulgaria
DCC 1 - Ruse, EOOD
Rousse, Bulgaria
DCC 'Alexandrovska', EOOD
Sofia, Bulgaria
DCC Focus 5 - MEOH OOD
Sofia, Bulgaria
Military Medical Academy - MHAT - Sofia
Sofia, Bulgaria
UMHAT 'Sv. Ivan Rilski', EAD
Sofia, Bulgaria
Toronto Western Hospital
Toronto, Ontario, Canada
Centro Medico Prosalud
Santiago, Chile
CTR Estudios
Santiago, Chile
Enroll Spa
Santiago, Chile
BioMedica Research Group
Santiago, Chile
Clinical Research Chile SpA.
Valdivia, Chile
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Dongguan People's Hospital
Dongguan, Guangdong, China
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Zhongshan TCM Hospital
Zhongshan, Guangdong, China
Hainan General Hospital
Haikou, Hainan, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Xiangya Hospital, Central South University
Changsha, Hu'nan, China
ZhuZhou Central Hospital
Zhuzhou, Hu'nan, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsushe, China