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

  • STATUS
    Recruiting
  • End date
    Sep 25, 2023
  • participants needed
    600
  • sponsor
    Celgene
Updated on 6 September 2020
Investigator
Associate Director Clinical Trial Disclosure
Primary Contact
Concord Repatriation General Hospital (3.5 mi away) Contact
+418 other location
corticosteroids
endoscopy
abdominal pain
ileal disease

Summary

This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease.

Details
Treatment Placebo, Ozanimod
Clinical Study IdentifierNCT03440372
SponsorCelgene
Last Modified on6 September 2020

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Eligibility

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Inclusion Criteria

Is your age between 12 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Crohn's Disease or Inflammatory bowel disease or Crohn's Disease (Pediatric)?
Subjects must satisfy the following criteria to be enrolled in the study
Aged 12-75 years 2. 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 4. Patient has met each of the following clinical and endoscopic criteria
Crohn's Disease Activity Index (CDAI) score 220 and 450
Average daily stool frequency 4 points and/or an abdominal pain of 2 points
SES-CD score of 6 (or SES-CD 4 in subjects with isolated ileal disease)

Exclusion Criteria

The presence of any of the following will exclude a subject from enrollment or at the time point specified in the following criteria
Subject has a diagnosis of UC, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, subjects with colonic or ileal strictures that are not passable with an age-appropriate colonoscope that the endoscopist normally uses in clinical practice, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded
Current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the physician's judgement, surgical or medical intervention within 12 weeks of entry into the study, or need for ileostomy or colostomy
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