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NCT03467958 · ClinicalTrials.gov registry record · Phase 3
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
A Phase 3 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 3
- Development phase
- 854
- Enrollment target
NCT03467958: Clinical Trial Phase 3 study, sponsored by Celgene.
NCT03467958 is a Phase 3 study that was terminated before completion, run by Celgene. The registered enrollment target is 854 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03467958, a Phase 3 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 854 participants
- Enrollment target
Study Summary
This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.
Primary Outcome
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liq
Interventions
- DRUG Ozanimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 854 participants |
| Start Date | 2018-08-24 |
| Est. Completion | 2024-10-31 |
| Phase | Phase 3 |
Why NCT03467958 stopped before completion
NCT03467958 is an interventional study that assigns participants to a tested intervention. The registered 854 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 (11% higher).
The record links to 0 conditions, and to 1 intervention - of which Ozanimod is the first listed.
NCT03467958 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03467958 about?
NCT03467958 is a clinical study titled "An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease". This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.
What is the current status of trial NCT03467958?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 854 participants. The study started on 2018-08-24. Estimated completion is 2024-10-31.
What interventions are being tested in trial NCT03467958?
The interventions under investigation include: Ozanimod (DRUG).
Who is sponsoring clinical trial NCT03467958?
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 NCT03467958's enrollment target sits among peer trials
854 384th of 2000 higher than 1,616 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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