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.
18 Years to 75 Years
Accepting Healthy Volunteers?
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.
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