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Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease | Clinical Trials | Clareo Health

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

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

NCT03440385•Celgene

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
•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
•Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
•Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
•Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Exclusion Criteria

•Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
•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

Locations (368)

Local Institution - 202

Scottsdale, Arizona, United States

Ucsd Medical Center

La Jolla, California, United States

Local Institution - 010

Lancaster, California, United States

Southern California Research Institute Medical Group, Inc.

Los Angeles, California, United States

Matrix Clinical Research Inc

Los Angeles, California, United States

Facey Medical Foundation (Parent)

Mission Hills, California, United States

Local Institution - 093

Pasadena, California, United States

Sutter Medical Group

Roseville, California, United States

Local Institution - 280

Sacramento, California, United States

Local Institution - 281

San Francisco, California, United States

Key Dates

Start Date

March 7, 2018

Primary Completion Date

November 21, 2023

Completion Date

November 21, 2023

Last Updated

December 5, 2024

Enrollment

606

ACTUAL participants

Conditions

Crohn Disease

Interventions

Ozanimod

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

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