Recruiting

Phase 3

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

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07438496

Conditions

Lupus Erythematosus, Systemic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Nipocalimab

Placebo

Standard of care treatment

Study Details

Brief 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).

Conditions

Lupus Erythematosus, Systemic

Study ID

NCT07438496

Start date

Mar 5, 2026

Status verified date

Aug, 2026

Completion date

Nov 7, 2031

Anticipated

Primary completion date

Dec 6, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nipocalimab

Participants will receive nipocalimab up to Week 52 in the double blind treatment period along with standard of care treatments. At Week 52, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.

placebo comparator: Placebo

Participants will receive placebo up to Week 52 in the double blind treatment period along with standard of care treatment. At Week 52, eligible participants from both studies will have the option to enter an OLE period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.

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.

Primary outcome measure

Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 52 [ Time Frame: Week 52 ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210 Participate-In-This-Study1@its.jnj.com

Locations

David S Hallegua MD A Professional Corporation

Recruiting

Beverly Hills, California, United States, 90211

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis

Recruiting

Hemet, California, United States, 92543

Advanced Medical Research

Recruiting

La Palma, California, United States, 90623

Medvin Clinical Research San Leandro

Recruiting

San Leandro, California, United States, 94578

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Recruiting

Torrance, California, United States, 90502

Solace Clinical Research California

Recruiting

Tustin, California, United States, 92780

Inland Rheumatology Clinical Trials Inc.

Recruiting

Upland, California, United States, 91786

Arthritis & Rheumatic Disease Specialties

Recruiting

Aventura, Florida, United States, 33180

Clinical Research of West Florida 1

Recruiting

Clearwater, Florida, United States, 33765

Avanti Clinical Research Corp

Recruiting

Hialeah, Florida, United States, 33013

LeJenue Research Associates PLLC

Recruiting

Miami, Florida, United States, 33126

Pro-Care Research Center, Corp.

Recruiting

Miami Gardens, Florida, United States, 33014

Floridian Clinical Research LLC

Recruiting

Miami Lakes, Florida, United States, 33016

Integral Rheumatology And Immunology Specialists

Recruiting

Plantation, Florida, United States, 33324

Clinical Research of West Florida

Recruiting

Tampa, Florida, United States, 33606

Atlanta Research Center for Rheumatology

Recruiting

Marietta, Georgia, United States, 30060

Willow Rheumatology and Wellness PLLC

Recruiting

Willowbrook, Illinois, United States, 60527

Accurate Clinical Research, Inc.

Recruiting

Lake Charles, Louisiana, United States, 70605

Revive Research Institute

Recruiting

Sterling Heights, Michigan, United States, 48313

Rutgers New Jersey Medical School

Recruiting

Newark, New Jersey, United States, 07103

Arthritis Rheumatic And Back Disease Associates

Recruiting

Voorhees Township, New Jersey, United States, 08043

Joint and Muscle Research Institute

Recruiting

Charlotte, North Carolina, United States, 28204

DJL Clinical Research, PLLC

Recruiting

Charlotte, North Carolina, United States, 28211

Cross Creek Medical Clinic

Recruiting

Fayetteville, North Carolina, United States, 28304 4422

Paramount Medical Research & Consulting

Recruiting

Middleburg Heights, Ohio, United States, 44130

Clinical Research Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19114

West Tennessee Research Institute

Recruiting

Jackson, Tennessee, United States, 38305

Amarillo Center for Clinical Research

Recruiting

Amarillo, Texas, United States, 79124

Arthritis and Rheumatology Research Institute

Recruiting

Frisco, Texas, United States, 75035

R and H Clinical Research

Recruiting

Katy, Texas, United States, 77449

Southwest Rheumatology Research LLC

Recruiting

Mesquite, Texas, United States, 75150

Texas Rheumatology Research Institute LLC

Recruiting

Plano, Texas, United States, 75024

Epic Medical Research 1

Recruiting

Red Oak, Texas, United States, 75154

Fort Bend Rheumatology Associates PLLC

Recruiting

Sugar Land, Texas, United States, 77479

Carilion Clinic Virginia Tech Carilion School of Medicine

Recruiting

Roanoke, Virginia, United States, 24011

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.