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NCT03440372 · ClinicalTrials.gov registry record · Phase 3

Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

A Phase 3 study, sponsored by Celgene.

Terminated
Registry status
Phase 3
Development phase
625
Enrollment target

NCT03440372: Clinical Trial Phase 3 study, sponsored by Celgene.

NCT03440372 is a Phase 3 study that was terminated before completion, run by Celgene. The registered enrollment target is 625 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03440372, a Phase 3 study, was terminated before completion, sponsored by Celgene.

TERMINATED
Registry status
Phase 3
Development phase
625 participants
Enrollment target

Study Summary

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

Primary Outcome

Crohn's Disease Activity Index (CDAI) is a composite score used to measure the clinical activity of Crohn's disease. CDAI uses 8 variables: number of soft/liquid stools, severity of abdominal pain (0=none to 3=severe), general well-being (0=well to 4=terrible), presence of complications, need for antidiarrheal drugs, presence of abdominal mass, hematocrit, and change in body weight. Scores for stool number, abdominal pain, and well-being are summed over the 7 days before each visit. The other fa

Interventions

  • OTHER Placebo
  • DRUG Ozanimod

Trial Details

FieldValue
Enrollment Target 625 participants
Start Date 2018-02-27
Est. Completion 2024-10-01
Phase Phase 3
Celgene

308 total trials

Why NCT03440372 stopped before completion

NCT03440372 is an interventional study that assigns participants to a tested intervention. The registered 625 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 (19% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03440372 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03440372 about?

NCT03440372 is a clinical study titled "Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease". This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

What is the current status of trial NCT03440372?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 625 participants. The study started on 2018-02-27. Estimated completion is 2024-10-01.

What interventions are being tested in trial NCT03440372?

The interventions under investigation include: Placebo (OTHER), Ozanimod (DRUG).

Who is sponsoring clinical trial NCT03440372?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03440372's enrollment target sits among peer trials

625 586th of 2000 higher than 1,414 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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Source: ClinicalTrials.gov NCT03440372, the US trial registry maintained by the National Library of Medicine. NCT03440372 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.