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Phase III

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

  • Study HIC#:2000022715
  • Last Updated:06/02/2022

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.

  • Age12 years - 75 years
  • GenderBoth
  • Start Date04/09/2021
  • End Date06/27/2023

Trial Purpose and Description

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.

Eligibility Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

  1. Aged 12-75 years 
  2. Crohn's disease for ≥ 3 months on endoscopy and on histological exam 
  3. 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:

    1. 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.
    2. 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.

    Principal Investigator

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