Summary

for people ages 18-75 (full criteria)
at La Jolla, 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, MULTI CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS INDUCTION THERAPY FOR MODERATELY TO SEVERLY 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 18-75

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

  1. Aged 18-75 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 2 criteria: 1) Crohn's Disease Activity Index(CDAI) score ≥ 220 and ≤ 450. 2) Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points.

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. Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis or known strictures or stenosis leading to symptoms of obstruction.
  2. Current stoma, ileal-anal pouch anastomosis, symptomatic fistula, or need for ileostomy or colostomy

Locations

  • UCSD Medical Center not yet accepting patients
    La Jolla California 92037 United States
  • Kindred Medical Institute for Clinical Trials, LLC not yet accepting patients
    Corona California 92879 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT03440385
Phase
Phase 3
Study Type
Interventional
Last Updated