A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
- Lupus Erythematosus, Systemic
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 600
- Started
- 5 March 2026
- Main results due
- 6 December 2028
- Study sites
- 260
- Registry updated
- 25 September 2026
Can you take part?
- Ages 18 years to 75 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria:- * Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening * Clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to (\>=) 24 weeks prior to screening and meeting european league against rheumatism/american college of rheumatology (EULAR/ACR) classification criteria * Must have a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score \>= 6 and a clinical SLEDAI-2K \>= 4 at screening, AND a clinical SLEDAI-2K score \>= 4 points at Week 0. For eligibility, points attributed to "lupus headache," "alopecia," and "organic brain syndrome" are excluded * Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at screening and a negative urine (β- hCG) test at Week 0 prior to randomization * Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening Exclusion Criteria: * History of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder (s) or clinically significant abnormalities in screening laboratory * Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications * Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of SLE or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant * Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins * Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(260)
David S Hallegua MD A Professional Corporation
Beverly Hills, California, United States
Recruiting
Providence Medical Foundation
Fullerton, California, United States
Recruiting
Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis
Hemet, California, United States
Recruiting
Advanced Medical Research
La Palma, California, United States
Recruiting
Medvin Clinical Research San Leandro
San Leandro, California, United States
Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Recruiting
Solace Clinical Research California
Tustin, California, United States
Recruiting
Inland Rheumatology Clinical Trials Inc.
Upland, California, United States
Recruiting
Denver Arthritis Clinic
Denver, Colorado, United States
Recruiting
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States
Recruiting
Clinical Research of West Florida 1
Clearwater, Florida, United States
Recruiting
Avanti Clinical Research Corp
Hialeah, Florida, United States
Recruiting
LeJenue Research Associates PLLC
Miami, Florida, United States
Recruiting
Pro-Care Research Center, Corp.
Miami Gardens, Florida, United States
Recruiting
Floridian Clinical Research LLC
Miami Lakes, Florida, United States
Recruiting
Integral Rheumatology And Immunology Specialists
Plantation, Florida, United States
Recruiting
Clinical Research of West Florida
Tampa, Florida, United States
Recruiting
Atlanta Research Center for Rheumatology
Marietta, Georgia, United States
Recruiting
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, United States
Recruiting
Accurate Clinical Research, Inc.
Lake Charles, Louisiana, United States
Recruiting
Revive Research Institute
Sterling Heights, Michigan, United States
Recruiting
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Recruiting
Arthritis Rheumatic And Back Disease Associates
Voorhees Township, New Jersey, United States
Recruiting
Joint and Muscle Research Institute
Charlotte, North Carolina, United States
Recruiting
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States
Recruiting
Cross Creek Medical Clinic
Fayetteville, North Carolina, United States
Recruiting
Paramount Medical Research & Consulting
Middleburg Heights, Ohio, United States
Recruiting
Clinical Research Philadelphia
Philadelphia, Pennsylvania, United States
Recruiting
West Tennessee Research Institute
Jackson, Tennessee, United States
Recruiting
Amarillo Medical Specialists Rheumatology
Amarillo, Texas, United States
Recruiting
Amarillo Center for Clinical Research
Amarillo, Texas, United States
Recruiting
Arthritis and Rheumatology Research Institute
Frisco, Texas, United States
Recruiting
R and H Clinical Research
Katy, Texas, United States
Recruiting
Southwest Rheumatology Research LLC
Mesquite, Texas, United States
Recruiting
Texas Rheumatology Research Institute LLC
Plano, Texas, United States
Recruiting
Epic Medical Research 1
Red Oak, Texas, United States
Recruiting
Fort Bend Rheumatology Associates PLLC
Sugar Land, Texas, United States
Recruiting
Carilion Clinic Virginia Tech Carilion School of Medicine
Roanoke, Virginia, United States
Recruiting
ARCIS Salud SRL Aprillus asistencia e investigacion
Buenos Aires, Argentina
Recruiting
Centro Privado de Medicina Familiar
Buenos Aires, Argentina
Recruiting
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
CABA, Argentina
Recruiting
Centro de Investigacion en Enfermedades Reumaticas CIER
Ciudad de Buenos Aires, Argentina
Recruiting
Arsema
Ciudad de Buenos Aires, Argentina
Recruiting
Global Psy Asociacion Civil
La Plata, Argentina
Recruiting
Cer Instituto Medico
Quilmes, Argentina
Recruiting
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Argentina
Recruiting
Sanatorio de la Mujer
Rosario, Argentina
Recruiting
MR Medicina Reumatologica
San Fernando, Argentina
Recruiting
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Argentina
Recruiting
BOX HILL
Box Hill, Australia
Recruiting
Footscray Hospital, Western Health
Footscray, Australia
Recruiting
Ipswich Hospital
Ipswich, Australia
Recruiting
Hospital das Clinicas - UFG
Goiânia, Brazil
Recruiting
CMIP - Centro Mineiro de Pesquisa Ltda
Juiz de Fora, Brazil
Recruiting
Hospital Moinhos de Vento
Porto Alegre, Brazil
Recruiting
Hospital De Clinicas De Porto Alegre
Porto Alegre, Brazil
Recruiting
LMK Servicos Medicos S S
Porto Alegre, Brazil
Recruiting
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil
Recruiting
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Ribeirão Preto, Brazil
Recruiting
SER - Servicos Especializados em Reumatologia da Bahia
Salvador, Brazil
Recruiting
Showing 60 of 260 sites — filter to narrow it down. 259 of the 260 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07438496. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me