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
  • New Hope Research Development accepting new patients
    West Covina California 91790 United States
  • Southern California Research Institute Medical Group, Inc. accepting new patients
    Los Angeles California 90045 United States
  • Havana Research Institute LLC accepting new patients
    Pasadena California 91105 United States
  • Facey Medical Foundation (Parent) not yet accepting patients
    Mission Hills California 91345 United States
  • OM Research accepting new patients
    Lancaster California 93534 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT03440385
Phase
Phase 3
Study Type
Interventional
Last Updated
September 11, 2018