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NCT07438496 · ClinicalTrials.gov registry record · Phase 3
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
A Phase 3 study of Lupus Erythematosus, Systemic, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
- 5
- Study locations
NCT07438496: Recruiting Phase 3 study of Lupus Erythematosus, Systemic, sponsored by Janssen Research & Development.
NCT07438496 is a Phase 3 study of Lupus Erythematosus, Systemic that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 600 participants, above the 183-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (228% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07438496, a Phase 3 study of Lupus Erythematosus, Systemic, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
- 5
- Study locations
Study 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).
Primary Outcome
SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLE Disease Activity Index 2000 (SLEDAI-2K), no British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as no new A or less than or equal to \<= 1 new B items compared to baseline, no worsening in Physician's Global Assessment (PGA \[greater than {\>} 10 percent {%} increase from baseline\]).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nipocalimab
- DRUG Standard of care treatment
Study Locations (5)
California
- Advanced Medical Research - La Palma
Florida
- Clinical Research of West Florida - Tampa
North Carolina
- Joint and Muscle Research Institute - Charlotte
Ohio
- Paramount Medical Research & Consulting - Middleburg Heights
Pennsylvania
- Clinical Research Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2026-03-05 |
| Est. Completion | 2031-11-07 |
| Phase | Phase 3 |
What NCT07438496 shows while recruiting
NCT07438496 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 183-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (228% higher).
The record links to 1 condition, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT07438496 lists 5 locations in 5 states (California, Florida, North Carolina).
Frequently Asked Questions
What is clinical trial NCT07438496 about?
NCT07438496 is a clinical study titled "A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus". 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 the current status of trial NCT07438496?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2026-03-05. Estimated completion is 2031-11-07.
What conditions does trial NCT07438496 study?
This clinical trial studies the following conditions: Lupus Erythematosus, Systemic.
What interventions are being tested in trial NCT07438496?
The interventions under investigation include: Placebo (DRUG), Nipocalimab (DRUG), Standard of care treatment (DRUG).
Who is sponsoring clinical trial NCT07438496?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07438496 being conducted?
This trial has 5 study locations across California, Florida, North Carolina, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07438496's enrollment target sits among peer trials
600 1st of 29 higher than 29 of 29 other Lupus Erythematosus, Systemic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Erythematosus, Systemic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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