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NCT03464097 · ClinicalTrials.gov registry record · Phase 3
A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
A Phase 3 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 3
- Development phase
- 550
- Enrollment target
NCT03464097: Clinical Trial Phase 3 study, sponsored by Celgene.
NCT03464097 is a Phase 3 study that was terminated before completion, run by Celgene. The registered enrollment target is 550 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03464097, a Phase 3 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 550 participants
- Enrollment target
Study Summary
This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.
Primary Outcome
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/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-b
Interventions
- OTHER Placebo
- DRUG Ozanimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2018-06-27 |
| Est. Completion | 2024-10-03 |
| Phase | Phase 3 |
Why NCT03464097 stopped before completion
NCT03464097 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03464097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03464097 about?
NCT03464097 is a clinical study titled "A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease". This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.
What is the current status of trial NCT03464097?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 550 participants. The study started on 2018-06-27. Estimated completion is 2024-10-03.
What interventions are being tested in trial NCT03464097?
The interventions under investigation include: Placebo (OTHER), Ozanimod (DRUG).
Who is sponsoring clinical trial NCT03464097?
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 NCT03464097's enrollment target sits among peer trials
550 680th of 2000 higher than 1,312 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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