An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Celgene

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: RPC1063

Study type: Interventional

Funder types: Industry

Identifiers

NCT02531126

2015-001600-64 (EudraCT Number)

U1111-1218-0284 (Registry Identifier)

RPC01-3102

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis. Only those participants who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible.

Full description

This is an extension study trial. Eligible participants from the RPC01-3101 and RPC01-202 trials were able to roll-over in this trial to receive study medication until March 2023 or until the Sponsor discontinues the development program, whichever comes first.

Enrollment: 877 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:

• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial

Exclusion Criteria:

• Receiving treatment with breast cancer resistance protein inhibitors
• Clinically relevant cardiovascular conditions
• Liver function impairment

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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877 participants in 1 patient group

RPC0163 (Ozanimod)

Experimental group

Treatment:

Drug: RPC1063