Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

  • End date
    Jun 28, 2024
  • participants needed
  • sponsor
Updated on 25 October 2022
abdominal pain
crohn's disease
ileal 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.

Condition Crohn Disease
Treatment Placebo, Ozanimod
Clinical Study IdentifierNCT03440372
Last Modified on25 October 2022


Yes No Not Sure

Inclusion Criteria

Crohn's disease for ≥ 3 months on endoscopy and on histological exam
Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapies
Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
An average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Exclusion Criteria

Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
Has extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition
Current stoma, ileal-anal pouch anastomosis, or fistula
Other protocol-defined inclusion/exclusion criteria apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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