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NCT02289417 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 170
- Enrollment target
NCT02289417: Completed Phase 2 study, sponsored by Amgen.
NCT02289417 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 170 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02289417, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 170 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the clinical efficacy, safety and tolerability of apremilast (30 mg twice daily \[BID\] and 40 mg BID), compared with placebo, in participants with active Ulcerative Colitis (UC).
Primary Outcome
Clinical remission was defined as a total Mayo score ≤ 2 points, with no individual subscore exceeding 1 point. The TMS is an instrument designed to measure disease activity of UC. The Mayo score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. * Stool Frequency Subscore (SFS) * Rectal Bleeding Subscore (RBS) * Endoscopy Subscore * Physician's Global Assessment (PGA). Two-sided 95% confidence intervals (CI) for th
Interventions
- DRUG Placebo
- DRUG Apremilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2015-01-08 |
| Est. Completion | 2019-06-03 |
| Phase | Phase 2 |
What the finished NCT02289417 record still lists
NCT02289417 is an interventional study that assigns participants to a tested intervention. The registered 170 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 (28% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02289417 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02289417 about?
NCT02289417 is a clinical study titled "Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis". The purpose of the study is to evaluate the clinical efficacy, safety and tolerability of apremilast (30 mg twice daily \[BID\] and 40 mg BID), compared with placebo, in participants with active Ulcerative Colitis (UC).
What is the current status of trial NCT02289417?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 170 participants. The study started on 2015-01-08. Estimated completion is 2019-06-03.
What interventions are being tested in trial NCT02289417?
The interventions under investigation include: Placebo (DRUG), Apremilast (DRUG).
Who is sponsoring clinical trial NCT02289417?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02289417's enrollment target sits among peer trials
170 399th of 2000 higher than 1,598 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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