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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
2026-05-08
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 (69)
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
Solace Clinical Research California
Tustin, California, United States
Inland Rheumatology Clinical Trials Inc.
Upland, California, 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
Floridian Clinical Research LLC
Miami Lakes, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, United States
Accurate Clinical Research, Inc.
Lake Charles, Louisiana, 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
Clinical Research Philadelphia
Philadelphia, Pennsylvania, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Arthritis and Rheumatology Research Institute
Allen, Texas, United States
Amarillo Center for Clinical Research
Amarillo, 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
ARCIS Salud SRL Aprillus asistencia e investigacion
Buenos Aires, Argentina
Centro Privado de Medicina Familiar
Buenos Aires, Argentina
Centro de Investigacion en Enfermedades Reumaticas CIER
Ciudad de Buenos Aires, Argentina
Arsema
Ciudad de Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Argentina
MR Medicina Reumatologica
San Fernando, Argentina
Hospital das Clinicas - UFG
Goiânia, Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, Brazil
LMK Servicos Medicos S S
Porto Alegre, Brazil
Fundacao do ABC Centro Universitario FMABC
Santo André, Brazil
Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
São José do Rio Preto, Brazil
ESHO Empresa De Servicos Hospitalares S A
São Paulo, Brazil
Peking University People's Hospital
Beijing, China
Linfen Central Hospital
Linfen, China
Ningbo medical center lihuili hospital
Ningbo, China
Shenshan Medical Center Memorial Hospital of Sun Yat Sen University
Shanwei, China
Shanxi Bethune Hospital
Taiyuan, China
Rambam Health Care Campus
Haifa, Israel
Carmel Medical Center
Haifa, Israel
Hadassah Ein-Qarem Medical Center
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel
Galilee Medical Center
Nahariya, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Tokai University Hospital
Isehara, Japan
Shinkenko Clinic
Naha, Japan
St. Luke's International Hospital
Tokyo, Japan
Hospital Sultan Ismail
Johor Bahru, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Umum Sarawak
Kuching, Malaysia
Sunway Medical Centre
Petaling Jaya, Malaysia
Hospital Taiping
Taiping, Malaysia
NTU Biomedical Park Hospital
Hsinchu, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
Ankara University Medical Faculty
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, Turkey (Türkiye)
Firat University Hospital
Elâzığ, Turkey (Türkiye)
Sanko Universitesi Hastanesi
Gaziantep, Turkey (Türkiye)
Marmara University Istanbul Pendik Education and Research Hospital
Istanbul, Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty
Konya, Turkey (Türkiye)
Peterborough City Hospital
Peterborough, United Kingdom
Southampton University Hospital
Southampton, United Kingdom
Haywood Hospital
Stoke-on-Trent, United Kingdom