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

Celgene

Status and phase: Active, not recruiting; 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)

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1,200 participants in 1 patient group

Administration of oral Ozanimod

Experimental group

Treatment:

Drug: Ozanimod