Induction Study #1 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 Palo Alto, California and other locations
Dates
study started
completion around

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 #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

Keywords

Crohn Disease, Crohn's Disease, Oral, Ozanimod, Moderately active, Severely active, RPC01, RPC01-3201, Administration of oral Ozanimod

Eligibility

You can join if…

Open to people ages 18-75

  • 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)

You CAN'T join if...

  • 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

Locations

  • Palo Alto Center-Palo Alto Medical Foundation Research Institute
    Palo Alto California 94304 United States
  • Local Institution - 284
    Camarillo California 93012 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting Sign up for this study
ID
NCT03440372
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 600 study participants
Last Updated