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NCT02531126 · ClinicalTrials.gov registry record · Phase 3
An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
A Phase 3 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 877
- Enrollment target
NCT02531126: Completed Phase 3 study, sponsored by Celgene.
NCT02531126 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 877 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02531126, a Phase 3 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 877 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis. Only those participants who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible.
Primary Outcome
Number of participants experiencing TEAEs, Serious TEAEs, TEAEs leading to discontinuation and TEAEs of special interest. TEAE is defined as any event with an onset date on or after the first dose date, or any ongoing event on the first dose date that worsens in severity on or after the first dose date, and until 90 days following the last dose of treatment with the study drug.
Interventions
- DRUG RPC1063
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 877 participants |
| Start Date | 2015-12-02 |
| Est. Completion | 2024-12-19 |
| Phase | Phase 3 |
What the finished NCT02531126 record still lists
NCT02531126 is an interventional study that assigns participants to a tested intervention. The registered 877 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 1 intervention - of which RPC1063 is the first listed.
NCT02531126 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02531126 about?
NCT02531126 is a clinical study titled "An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis". The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis. Only those participants who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the ope...
What is the current status of trial NCT02531126?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 877 participants. The study started on 2015-12-02. Estimated completion is 2024-12-19.
What interventions are being tested in trial NCT02531126?
The interventions under investigation include: RPC1063 (DRUG).
Who is sponsoring clinical trial NCT02531126?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02531126's enrollment target sits among peer trials
877 371st of 2000 higher than 1,629 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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