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

NCT03440385 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 606

Last updated 2024-12-05

Study results available
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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.

Conditions

  • Crohn Disease

Interventions

DRUG

Ozanimod

Specified dose on specified days

OTHER

Placebo

Specified dose on specified days

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2023-11-21
Completion
2023-11-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • China
  • Colombia
  • Finland
  • France
  • Georgia
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Israel
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Russia
  • Senegal
  • Serbia
  • Slovakia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03440385 on ClinicalTrials.gov