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

Primary Purpose

Ulcerative Colitis

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

RPC1063

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RPC0163 (Ozanimod)

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Number of Participants with Adverse Events (AEs)

Number of Participants with Serious Adverse Events (SAEs)

Number of Participants with TEAEs Leading to Discontinuation of Investigational Drug

Number of Participants with Adverse Events of Special Interest

Secondary Outcome Measures

Proportion of participants with clinical remission

Proportion of participants with a clinical response

Proportion of participants with endoscopic improvement

Proportion of participants with mucosal healing

Proportion of participants with corticosteroid-free remission

Change from Baseline in complete Mayo score

Change from Baseline in partial Mayo score

Change from Baseline in 9-point Mayo score

Proportion of participants with histologic remission

Proportion of participants with clinical response in participants who had previously received anti-TNF therapy

Proportion of participants with clinical remission in participants who had previously received anti-TNF therapy

Proportion of participants with endoscopic improvement in participants who had previously received anti-TNF therapy

Full Information

NCT ID

NCT02531126

First Posted

August 20, 2015

Last Updated

September 15, 2023

Sponsor

Celgene

1. Study Identification

Unique Protocol Identification Number

NCT02531126

Brief Title

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

Official Title

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 2, 2015 (Actual)

Primary Completion Date

February 27, 2025 (Anticipated)

Study Completion Date

February 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celgene

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

878 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RPC0163 (Ozanimod)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

RPC1063

Other Intervention Name(s)

Ozanimod

Primary Outcome Measure Information:

Title

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Time Frame