Summary

for people ages 12-75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

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.

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

You can join if…

Open to people ages 12-75

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
  2. 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:
  3. Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450.
  4. Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points.
  5. SES-CD score of ≥ 6 (or SES-CD ≥ 4 in subjects with isolated ileal disease)

You CAN'T join if...

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.

Locations

  • University of California at San Francisco not yet accepting patients
    San Francisco California 94158 United States
  • UC Davis Health - Gastroenterology and Hepatology Clinical Trials Unit not yet accepting patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
http://www.crohnsstudies.com/
ID
NCT03440385
Phase
Phase 3
Study Type
Interventional
Last Updated