Induction Study #2 of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

  • STATUS
    Recruiting
  • sponsor
    Celgene
Updated on 15 September 2021
corticosteroids
endoscopy
abdominal pain
ileal disease

Summary

This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the effect of oral ozanimod as a potential induction treatment for subjects with moderately to severely active Crohn's Disease.

Description

For more information, please visit www.crohnsstudies.com.

Details
Condition Crohn's, Crohn's Disease, Gastroenterology, Crohn's Disease (Pediatric), Crohns
Clinical Study IdentifierTX279197
SponsorCelgene
Last Modified on15 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must satisfy the following criteria to be enrolled in the study
Aged 12-75 years
Crohn's disease for ≥ 3 months on endoscopy and on histological exam
Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy
Patient has met each of the following clinical and endoscopic criteria: a.) Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450; b.) Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points; c.) SES-CD score of ≥ 6 (or SES-CD ≥ 4 in subjects with isolated ileal disease)
Other eligibility criteria apply

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
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
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
Other eligibility criteria apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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