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, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely 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
12 Years to 75 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

        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 3. 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:

         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.

         3. SES-CD score of ≥ 6 (or SES-CD ≥ 4 in subjects with isolated ileal disease)

        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. 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.

At a Glance

National Government IDNCT03440385

IRB#IRB18-0443

Lead SponsorCelgene

Lead PhysicianRussell D. Cohen

Collaborator(s)N/A

EligibilityAll
12 Years to 75 Years
Recruiting