Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

  • STATUS
    Recruiting
  • End date
    Jun 28, 2024
  • participants needed
    600
  • sponsor
    Celgene
Updated on 16 September 2022
corticosteroids
endoscopy
abdominal pain
crohn's disease
immunomodulators
ileal disease

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.

Details
Condition Crohn Disease
Treatment Placebo, Ozanimod
Clinical Study IdentifierNCT03440385
SponsorCelgene
Last Modified on16 September 2022

Eligibility

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 therapy
Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Exclusion Criteria

Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
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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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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