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NCT01647516 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of Ozanimod in Ulcerative Colitis
A Phase 2 study of Ulcerative Colitis, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 199
- Enrollment target
- 20
- Study locations
NCT01647516: Completed Phase 2 study of Ulcerative Colitis, sponsored by Celgene.
NCT01647516 is a Phase 2 study of Ulcerative Colitis that has completed, run by Celgene. The registered enrollment target is 199 participants, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01647516, a Phase 2 study of Ulcerative Colitis, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 199 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).
Primary Outcome
Clinical Remission was defined as: Mayo score of \<2 points and with no individual subscore of \> 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ozanimod
Study Locations (20)
Other
- Universitair Ziekenhuis Leuven, Campus Gasthuisberg - Leuven
- Multiprofile Hospital for Active Treatment Kaspela - Plovdiv
- University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia - Sofia
- UMHAT Sv Ivan Rilski EAD - Sofia
- University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD - Sofia
- Military Medical Academy - Sofia
- Multiprofile Hospital for Active Treatment Doverie AD - Sofia
- Multiprofile Hospital for Active Treatment Sveti Panteleimon - Sofia AD - Sofia
- Multiprofile Hospital for Active Treatment Sofiamed - Sofia
California
- Anaheim Clinical Trials - Anaheim
- University of California San Diego - La Jolla
- Alliance Clinical Research - Oceanside
Maryland
- Chevy Chase Clinical Research - Chevy Chase
- Endoscopic Microsurgery Associates - Towson
Georgia
- Atlanta Gastroenterology Associates, LLC - Atlanta
Michigan
- Clinical Research Institute of Michigan, LLC - Chesterfield
New York
- Long Island Clinical Research Associates - Great Neck
North Carolina
- University of North Carolina - Chapel Hill
Ohio
- Consultants for Clinical Research - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2012-12-26 |
| Est. Completion | 2019-08-30 |
| Phase | Phase 2 |
What the finished NCT01647516 record still lists
NCT01647516 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01647516 names 20 study sites across 9 states, led by Other, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT01647516 about?
NCT01647516 is a clinical study titled "Efficacy and Safety Study of Ozanimod in Ulcerative Colitis". The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).
What is the current status of trial NCT01647516?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 199 participants. The study started on 2012-12-26. Estimated completion is 2019-08-30.
What conditions does trial NCT01647516 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT01647516?
The interventions under investigation include: Placebo (DRUG), Ozanimod (DRUG).
Who is sponsoring clinical trial NCT01647516?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01647516 being conducted?
This trial has 20 study locations across California, Georgia, Maryland, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01647516's enrollment target sits among peer trials
199 45th of 122 higher than 78 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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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