Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

a study on Crohn's Disease Inflammatory Bowel Disease

Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Crohn Disease, Crohn's Disease, Oral, Ozanimod, Moderately active, Severely active, RPC01, RPC01-3202, Administration of oral Ozanimod

Eligibility

For people ages 18-75

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

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

Locations

  • University Of California At San Francisco accepting new patients
    San Francisco California 94158 United States
  • UC Davis Health - Gastroenterology and Hepatology Clinical Trials Unit accepting new patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
BMS Clinical Trial Information FDA Safety Alerts and Recalls BMS Clinical Trial Patient Recruiting
ID
NCT03440385
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 600 study participants
Last Updated
Contact us about this trial