🔎 Trials Near Me

Home › Lupus › NCT07438496

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

RecruitingPhase 3

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Who can join

Ages 18 to 75 · All sexes

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

About the study

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).

What is being tested

Sponsor: Janssen Research & Development, LLC · Participants: 600 · Started: Mar 5, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07438496

Locations in the U.S.

CaliforniaDavid S Hallegua MD A Professional Corporation, Beverly Hills
Providence Medical Foundation, Fullerton
Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis, Hemet
Advanced Medical Research, La Palma
Medvin Clinical Research San Leandro, San Leandro
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance
Solace Clinical Research California, Tustin
Inland Rheumatology Clinical Trials Inc., Upland
ColoradoDenver Arthritis Clinic, Denver
FloridaArthritis & Rheumatic Disease Specialties, Aventura
Clinical Research of West Florida 1, Clearwater
Avanti Clinical Research Corp, Hialeah
LeJenue Research Associates PLLC, Miami
Pro-Care Research Center, Corp., Miami Gardens
Floridian Clinical Research LLC, Miami Lakes
Integral Rheumatology And Immunology Specialists, Plantation
Clinical Research of West Florida, Tampa
GeorgiaAtlanta Research Center for Rheumatology, Marietta
IllinoisWillow Rheumatology and Wellness PLLC, Willowbrook
LouisianaAccurate Clinical Research, Inc., Lake Charles
MichiganRevive Research Institute, Sterling Heights
New JerseyRutgers New Jersey Medical School, Newark
Arthritis Rheumatic And Back Disease Associates, Voorhees Township
North CarolinaDJL Clinical Research, PLLC, Charlotte
Joint and Muscle Research Institute, Charlotte
Cross Creek Medical Clinic, Fayetteville
OhioParamount Medical Research & Consulting, Middleburg Heights
PennsylvaniaClinical Research Philadelphia, Philadelphia
TennesseeWest Tennessee Research Institute, Jackson
TexasAmarillo Center for Clinical Research, Amarillo
Amarillo Medical Specialists Rheumatology, Amarillo
Arthritis and Rheumatology Research Institute, Frisco
R and H Clinical Research, Katy
Southwest Rheumatology Research LLC, Mesquite
Texas Rheumatology Research Institute LLC, Plano
Epic Medical Research 1, Red Oak
Fort Bend Rheumatology Associates PLLC, Sugar Land
VirginiaCarilion Clinic Virginia Tech Carilion School of Medicine, Roanoke

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.