Clinical Research Directory
Browse clinical research sites, groups, and studies.
An Extension Study to Learn More About the Long-Term 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. This is an extension study of 230LE303 and 230LE304 (TOPAZ-1 and TOPAZ-2). It will enroll participants who completed the treatment periods of either one of the parent studies. The main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is: \- How many participants have adverse events and serious adverse events? Researchers will also learn about the effect litifilimab has on controlling symptoms of SLE and lowering its activity. They will measure 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 British Isles Lupus Activity Group-2004 (BILAG-2004), among others. Researchers will also 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: * The Week 52 visit of studies 230LE303 and 230LE304 will be Day 1 of this study. * Participants who were receiving either a high or low dose of litifilimab in the parent studies will continue receiving the same doses. * Participants who were receiving placebo in the parent studies will be randomized to receive either a high or low dose of litifilimab. * All participants will receive litifilimab as injections under the skin once every 4 weeks. The treatment period will last 156 weeks. Participants may continue to take their standard of care medications. * Neither the researchers nor the participants will know which doses of litifilimab the participants are receiving. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 47 study visits. The total study duration for participants will be up to 180 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 giving litifilimab. The injector device is an automatic device that delivers the full dose in one injection without needing to push a plunger. Researchers will compare the safety and tolerability of the injector device and how the body reacts to it to the current prefilled syringe method. The substudy will last 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
2030-03-29
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Litifilimab
Administered as specified in the treatment arm.
Litifilimab-matching placebo
Administered as specified in the treatment arm.
Locations (182)
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
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
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
Precision Comprehensive Clinical Research Solutions
Colleyville, 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
Centro Medico Barrio Parque
Buenos Aires, Ciudad Autonoma Buenos Aires, 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
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
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
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
Jiujiang No.1 People's Hospital
Jiujiang, Jiangxi, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Jilin Province People's Hospital
Changchun, Jilin, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
The First Hospital of Jilin University
Changchun, China
IPS Centro Medico Julian Coronel S.A.
Cali, Valle del Cauca Department, Colombia
Fundacion Cardiomet CEQUIN S.A.S
Armenia, Colombia
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, Colombia
Clínica de la Costa S.A.S
Barranquilla, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.
Bogotá, Colombia
Servimed S.A.S.
Bucaramanga, Colombia
Preventive Care Ltda
Chía, Colombia
Healthy Medical Center
Zipaquirá, Colombia
Revmatologie s.r.o.
Brno, Czechia
Fakultni nemocnice Olomouc
Olomouc, Czechia
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, Drôme, France
NNA Hospital
Athens, Attica, Greece
Vita Verum Medical Egeszsegugyi Szolgaltato Bt.
Székesfehérvár, Fejér, Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, Hungary
Bekes Varmegyei Kozponti Korhaz
Gyula, Hungary
Vital Medical Center
Veszprém, Hungary
Rambam Health Care Campus
Haifa, Israel
Meir Medical Center
Kfar Saba, Israel
Tel Aviv Sourasky Medical Center Pt
Tel Aviv, Israel
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy
JCHO Chukyo Hospital
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, Japan
NHO Chibahigashi National Hospital
Chiba, Chiba, Japan
KKR Hamanomachi Hospital
Fukuoka, Fukuoka, Japan
NHO Kyushu Medical Center
Fukuoka, Fukuoka, Japan
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Fukuoka, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Tonan Hospital
Sapporo, Hokkaido, Japan
Japanese Red Cross Society Himeji Hospital
Himeji-shi, Hyōgo, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
NHO Yokohama Medical Center
Yokohama, Kanagawa, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo-To, Japan
Toho University Ohashi Medical Center
Meguro-ku, Tokyo-To, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-ku, Tokyo-To, Japan
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, Mexico
Centro de investigacion medica y reumatologia
Guadalajara, Jalisco, Mexico
Centro de Investigacion Clínica GRAMEL S.C
Mexico City, Mexico City, Mexico
Clinstile, S.A. de C.V.
Mexico City, Mexico City, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran
Mexico City, Mexico City, Mexico
Consultorio Privado Dr. Miguel Cortes Hernandez
Cuernavaca, Morelos, Mexico
Centro Peninsular de Investigacion Clinica, SCP
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
Centro de Investigacion Clinica Inmunoreumatologia - ACQ Medic
Lima, Peru
HMA - Hospital Maria Auxiliadora
Lima, Peru
Mary Mediatrix Medical Center
Lipa City, Batangas, Philippines
Davao Doctors Hospital
Davao City, Davao Region, Philippines
University of the Philippines Manila - Philippine General Hospital
Manila, National Capital Region, Philippines
St. Luke's Medical Center
Quezon City, National Capital Region, Philippines
Far Eastern University - Dr. Nicanor Reyes Medical Foundation
Quezon City, National Capital Region, Philippines
Ospital Ng Makati
City of Taguig, Philippines
The Medical City Iloilo
Iloilo City, Philippines
Medical Center Manila
Manila, Philippines
Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, Poland
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, Poland
Nzoz Bif-Med
Bytom, Poland
Pratia MCM Krakow
Krakow, Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
Malbork, Poland
Prywatna Praktyka Lekarska prof Pawel Hrycaj
Poznan, Poland
Gabinety Lekarskie Rivermed
Poznan, Poland
Przychodnia Care Access Warszawa
Warsaw, Poland
MICS Centrum Medyczne Warszawa
Warsaw, Poland
Centro Reumatologico
Caguas, Puerto Rico
S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
Brasov, Romania
S C Delta Health Care SRL
Bucharest, Romania
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca, Romania
S.C.Centrul Medical Unirea SRL
Iași, Romania
Institute of Rheumatology
Belgrade, Serbia
University Clinical Center of Serbia
Belgrade, Serbia
Clinical Center "Bezanijska Kosa "
Belgrade, Serbia
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea
Hospital Universitario Marques de Valdecilla
Santander, Castellón, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Quironsalud Infanta Luisa
Seville, Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Guy's Hospital
London, Greater London, United Kingdom
Doncaster Royal Infirmary
Doncaster, South Yorkshire, United Kingdom