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NCT04968912 · ClinicalTrials.gov registry record · Phase 2
A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 163
- Enrollment target
NCT04968912: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT04968912 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 163 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04968912, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 163 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.
Primary Outcome
The clinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome. The clinESSDAI includes 11 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain.
Interventions
- OTHER Placebo
- DRUG Nipocalimab
- DRUG Standard of Care Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2021-09-21 |
| Est. Completion | 2023-11-30 |
| Phase | Phase 2 |
What the finished NCT04968912 record still lists
NCT04968912 is an interventional study that assigns participants to a tested intervention. The registered 163 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 (23% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04968912 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04968912 about?
NCT04968912 is a clinical study titled "A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)". The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.
What is the current status of trial NCT04968912?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 163 participants. The study started on 2021-09-21. Estimated completion is 2023-11-30.
What interventions are being tested in trial NCT04968912?
The interventions under investigation include: Placebo (OTHER), Nipocalimab (DRUG), Standard of Care Treatment (DRUG).
Who is sponsoring clinical trial NCT04968912?
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 NCT04968912's enrollment target sits among peer trials
163 418th of 2000 higher than 1,583 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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