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

  • Interventional
  • Recruiting
  • NCT03440385
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years to 75 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

        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.

        Exclusion Criteria:

        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

At a Glance

National Government IDNCT03440385

IRB#IRB18-0443

Lead SponsorCelgene

Lead PhysicianRussell D. Cohen

Collaborator(s)N/A

EligibilityAll
18 Years to 75 Years
Recruiting