Have you or your loved ones been diagnosed with crohn disease?

You may be eligible to participate in a crohn disease clinical trial.

Have you or your loved ones been diagnosed with crohn disease? You may be eligible to participate in a crohn disease clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Crohn Disease Clinical Trial

NCT03464097 | Phase 3 | Interventional

Have you or your loved ones been diagnosed with crohn disease?

You may be eligible to participate in a crohn disease clinical trial.

Have you or your loved ones been diagnosed with crohn disease? You may be eligible to participate in a crohn disease clinical trial.

Recruiting

Male & Female

18 - 75

Years old

This study is looking to recruit 485 Participants

This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.

Show me more details

Details for the study

Brief Title

A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Official Title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Brief Summary

This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in <br /> participants with moderately to severely active Crohn's Disease.

Treatments and/or Procedures

Ozanimod

Specified dose on specified days

Placebo

Specified dose on specified days

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Proportion of participants with a Crohn's Disease Activity Index (CDAI) score of < 150

The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD

Weekk 52

Study Criteria

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