Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn'… (NCT03440372) | Clinical Trial Compass
TerminatedPhase 3
Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Stopped: Business objectives have changed.
United States625 participantsStarted 2018-02-27
Plain-language summary
This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Crohn's disease for ≥ 3 months on endoscopy and on histological exam
* Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapies
* Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
* An average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
* Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)
Exclusion Criteria:
* Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
* Has extensive small bowel resection (\>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition
* Current stoma, ileal-anal pouch anastomosis, or fistula
Other protocol-defined inclusion/exclusion criteria apply
What they're measuring
1
Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12