Have you or your loved ones been diagnosed with crohn disease?

You may be eligible to participate in a crohn disease clinical trial.

Have you or your loved ones been diagnosed with crohn disease? You may be eligible to participate in a crohn disease clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Crohn Disease Clinical Trial

NCT03440372 | Phase 3 | Interventional

Have you or your loved ones been diagnosed with crohn disease?

You may be eligible to participate in a crohn disease clinical trial.

Have you or your loved ones been diagnosed with crohn disease? You may be eligible to participate in a crohn disease clinical trial.

Recruiting

Male & Female

18 - 75

Years old

This study is looking to recruit 600 Participants

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.

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Details for the study

Brief Title

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

Official Title

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

Brief Summary

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

Treatments and/or Procedures

Ozanimod

Specified dose on specified days

Placebo

Specified dose on specified days

Study Criteria

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