RPC1063 for Ulcerative Colitis

Recruiting at 355 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Celgene

Must not be taking: Breast cancer resistance inhibitors

Disqualifiers: Cardiovascular conditions, Liver impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

878 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for people with moderate to severe ulcerative colitis who have already been part of earlier RPC1063 trials. They must meet the criteria from their previous participation to join this extension study.

Inclusion Criteria

If you want to know more about participating in a clinical trial with Bristol-Myers Squibb, visit www.BMSStudyConnect.com.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label extension

Participants continue to receive RPC1063 for long-term safety and efficacy evaluation

Until March 2023 or until the Sponsor discontinues the development program

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RPC1063

Trial Overview The trial is testing the long-term safety and effectiveness of a drug called RPC1063 in patients with ulcerative colitis who've used it before in prior studies.

Participant Groups

Group I: RPC0163 (Ozanimod) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

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Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania