A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

  • STATUS
    Recruiting
  • End date
    Dec 27, 2029
  • participants needed
    1200
  • sponsor
    Celgene
Updated on 22 September 2022
remission
crohn's disease

Summary

This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.

Details
Condition Crohn Disease
Treatment Ozanimod
Clinical Study IdentifierNCT03467958
SponsorCelgene
Last Modified on22 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Is not in clinical response or clinical remission after completing 12 weeks in the Induction Studies
Experience relapse or who complete the Maintenance Study
Complete a study of ozanimod for Crohn's Disease and meet the criteria for participation

Exclusion Criteria

Has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study
Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated
Is receiving treatment with any of the following drugs or interventions within the CYP2C8 inhibitors, inducers and Monoamine oxidase inhibitors
Other protocol-defined inclusion/exclusion criteria apply
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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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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