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The trial is taking place at:
A

Advanced Research for Health Improvement, LLC | Naples, FL

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An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

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Celgene

Status and phase

Enrolling
Phase 3

Conditions

Crohn Disease

Treatments

Drug: Ozanimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT03467958
RPC01-3204
2017-004295-55 (EudraCT Number)
U1111-1203-8203 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment

1,200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

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: CYP2C8 inducers; Monoamine oxidase inhibitors

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,200 participants in 1 patient group

Administration of oral Ozanimod
Experimental group
Treatment:
Drug: Ozanimod

Trial contacts and locations

799

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; Recruiting sites have contact information. Please contact the site directly. If there is no contact information,

Data sourced from clinicaltrials.gov

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