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Nipocalimab for 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

PHASE3 · Janssen Research & Development, LLC · NCT07438496

This trial tests nipocalimab versus placebo in adults with moderate to severe lupus to see if it reduces disease activity and symptoms.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment600 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorJanssen Research & Development, LLC (industry)
Drugs / interventionsnipocalimab
Locations69 sites (Beverly Hills, California and 68 other locations)
Trial IDNCT07438496 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, placebo-controlled trial adds nipocalimab or matching placebo to participants' standard-of-care treatment to measure effects on disease activity and safety. Eligible adults must have a confirmed SLE diagnosis for at least 24 weeks and meet predefined SLEDAI-2K and BILAG-2004 activity thresholds at screening. Participants are monitored with clinical disease activity scores, routine labs, ECGs, and pregnancy testing for those of childbearing potential. The study is sponsored by Janssen Research & Development and is conducted at outpatient rheumatology sites in the United States.

Who should consider this trial

Good fit: Adults with a confirmed diagnosis of SLE for ≥24 weeks who have active moderate-to-severe disease (meeting SLEDAI-2K and BILAG-2004 criteria) and are medically stable on standard-of-care therapy.

Not a fit: People with mild lupus, pregnant individuals, or those with unstable medical conditions or other exclusion criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, nipocalimab could reduce lupus flares and overall disease activity, leading to improved symptoms and quality of life for adults with moderate to severe SLE.

How similar studies have performed: Other biologic therapies for SLE, such as belimumab and anifrolumab, have demonstrated clinical benefit, while FcRn-targeting approaches like nipocalimab are a newer strategy with encouraging early data but limited phase 3 confirmation so far.

Eligibility criteria

Show full inclusion / exclusion 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 according to 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, excluding points attributed to "lupus headache," "alopecia," and "organic brain syndrome"
* 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

Where this trial is running

Beverly Hills, California and 68 other locations

+19 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Lupus Erythematosus, Systemic

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.