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NCT04882878 · ClinicalTrials.gov registry record · Phase 2
A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 228
- Enrollment target
NCT04882878: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT04882878 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 228 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04882878, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 228 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).
Primary Outcome
SLE SRI-4 composite response is a composite of at least 4-point improvement in SLE Disease Activity Index 2000(SLEDAI-2K), no worsening in British Isles Lupus Assessment Group (BILAG), no worsening in Physician's Global Assessment of Disease Activity score (PGA) and not meeting study treatment failure criteria.
Interventions
- OTHER Placebo
- DRUG Nipocalimab
- DRUG Standard-of-care treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2021-08-20 |
| Est. Completion | 2024-12-26 |
| Phase | Phase 2 |
What the finished NCT04882878 record still lists
NCT04882878 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04882878 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04882878 about?
NCT04882878 is a clinical study titled "A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus". The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).
What is the current status of trial NCT04882878?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 228 participants. The study started on 2021-08-20. Estimated completion is 2024-12-26.
What interventions are being tested in trial NCT04882878?
The interventions under investigation include: Placebo (OTHER), Nipocalimab (DRUG), Standard-of-care treatment (DRUG).
Who is sponsoring clinical trial NCT04882878?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04882878's enrollment target sits among peer trials
228 264th of 2000 higher than 1,736 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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