A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Act… (NCT03464097) | Clinical Trial Compass
TerminatedPhase 3
A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
Stopped: The study has terminated due to non-safety reasons; Business Objectives have changed.
United States, Argentina, Australia550 participantsStarted 2018-06-27
Plain-language summary
This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Inclusion Criteria:
* Fulfilled the inclusion criteria at time of entry into the induction study and completed the week 12 efficacy assessments of the induction study
* In clinical response and/or clinical remission and/or an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤ 1 with abdominal pain and stool frequency no worse than baseline at Week 12 of the Induction Study
Exclusion Criteria:
* Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula
* Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis
Other protocol-defined inclusion/exclusion criteria apply
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 52 as Observed
Timeframe: Week 52
2
Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline ≥ 50% Based on Observed Cases and Robarts Observed Scores