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A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2026-03-05
Completion Date
2031-11-07
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Nipocalimab
Nipocalimab will be administered.
Placebo
Placebo will be administered.
Standard of care treatment
Protocol-defined topical and systemic standard of care background treatments.
Locations (272)
David S Hallegua MD A Professional Corporation
Beverly Hills, California, United States
Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis
Hemet, California, United States
Advanced Medical Research
La Palma, California, United States
Providence Medical Foundation
Mission Viejo, California, United States
Medvin Clinical Research San Leandro
San Leandro, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Solace Clinical Research California
Tustin, California, United States
Inland Rheumatology Clinical Trials Inc.
Upland, California, United States
Denver Arthritis Clinic
Denver, Colorado, United States
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States
Clinical Research of West Florida 1
Clearwater, Florida, United States
Avanti Clinical Research Corp
Hialeah, Florida, United States
LeJenue Research Associates PLLC
Miami, Florida, United States
Pro-Care Research Center, Corp.
Miami Gardens, Florida, United States
Floridian Clinical Research LLC
Miami Lakes, Florida, United States
Integral Rheumatology And Immunology Specialists
Plantation, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Atlanta Research Center for Rheumatology
Marietta, Georgia, United States
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, United States
Accurate Clinical Research, Inc.
Lake Charles, Louisiana, United States
Revive Research Institute
Sterling Heights, Michigan, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Arthritis Rheumatic And Back Disease Associates
Voorhees Township, New Jersey, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States
Cross Creek Medical Clinic
Fayetteville, North Carolina, United States
Paramount Medical Research & Consulting
Middleburg Heights, Ohio, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Clinical Research Philadelphia
Philadelphia, Pennsylvania, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Amarillo Medical Specialists Rheumatology
Amarillo, Texas, United States
Amarillo Center for Clinical Research
Amarillo, Texas, United States
Arthritis and Rheumatology Research Institute
Frisco, Texas, United States
R and H Clinical Research
Katy, Texas, United States
Southwest Rheumatology Research LLC
Mesquite, Texas, United States
Texas Rheumatology Research Institute LLC
Plano, Texas, United States
Epic Medical Research 1
Red Oak, Texas, United States
Fort Bend Rheumatology Associates PLLC
Sugar Land, Texas, United States
Carilion Clinic Virginia Tech Carilion School of Medicine
Roanoke, Virginia, United States
ARCIS Salud SRL Aprillus asistencia e investigacion
Buenos Aires, Argentina
Centro Privado de Medicina Familiar
Buenos Aires, Argentina
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
CABA, Argentina
Centro de Investigacion en Enfermedades Reumaticas CIER
Ciudad de Buenos Aires, Argentina
Arsema
Ciudad de Buenos Aires, Argentina
Global Psy Asociacion Civil
La Plata, Argentina
Cer Instituto Medico
Quilmes, Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Argentina
Sanatorio de la Mujer
Rosario, Argentina
MR Medicina Reumatologica
San Fernando, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Argentina
BOX HILL
Box Hill, Australia
Footscray Hospital, Western Health
Footscray, Australia
Ipswich Hospital
Ipswich, Australia
Hospital das Clinicas - UFG
Goiânia, Brazil
CMIP - Centro Mineiro de Pesquisa Ltda
Juiz de Fora, Brazil
Hospital Moinhos de Vento
Porto Alegre, Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, Brazil
LMK Servicos Medicos S S
Porto Alegre, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Ribeirão Preto, Brazil
SER - Servicos Especializados em Reumatologia da Bahia
Salvador, Brazil
IDOR - Regional Bahia
Salvador, Brazil
Funfarme Sjrp
São José do Rio Preto, Brazil
Hospital Samaritano de Sao Paulo
São Paulo, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, Brazil
Cepes - Fmabc
São Paulo, Brazil
CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda
Vitória, Brazil
MC Medtech Services Ltd
Haskovo, Bulgaria
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
Plovdiv, Bulgaria
Diagnostic consulting center 1 Ruse EOOD
Rousse, Bulgaria
Diagnostic-Consultative Center (DCC) Aleksandrovska
Sofia, Bulgaria
Medical Center Hera EOOD
Sofia, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment Sofia
Sofia, Bulgaria
UMHAT 'Sveti Ivan Rilsky'
Sofia, Bulgaria
University Multi Profile Hospital for Active Treatment UMHAT St. Marina
Varna, Bulgaria
Peking University People's Hospital
Beijing, China
Xiangya Hospital Central South University
Changsha, China
West China School of Medicine/West China Hospital, Sichuan University
Cheng Du Shi, China
Dongguan People s Hospital
Dongguan, China
The First Affiliated Hospital Sun Yat-Sen University
Guangzhou, China
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, China
Anhui Provincial Hospital
Hefei, China
Jinhua municipal central hospital
Jinhua, China
Shandong Jining No.1 People's Hospital
Jining, China
Linfen Central Hospital
Linfen, China
The first affiliated hospital of Henan University of science and technology
Luoyang, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Nanjing Drum Tower Hospital
Nanjing, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
Ningbo medical center lihuili hospital
Ningbo, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Shenshan Medical Center Memorial Hospital of Sun Yat Sen University
Shanwei, China
Second Affiliated Hospital, SooChow University
Suzhou, China
Shanxi Bethune Hospital
Taiyuan, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Xinxiang Central Hospital
Xinxiang, China
Fakultní nemocnice u sv. Anny v Brn
Brno, Czechia
Revimex Pro s r o
Karvina Frystat, Czechia
Revmatologicky ustav
Prague, Czechia