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

Completed · Phase 3

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT02531126

Run by

Celgene

People needed

877

Starts

2015-12-02

Expected to finish

2024-12-19

Last updated by the study team

2025-12-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Receiving treatment with breast cancer resistance protein inhibitors
• Clinically relevant cardiovascular conditions
• Liver function impairment
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 144 — Tucson, Arizona, United States
• Local Institution - 102 — Anaheim, California, United States
• Local Institution - 117 — Mission Hills, California, United States
• Local Institution - 112 — Oak Lawn, Illinois, United States
• Local Institution - 119 — Baton Rouge, Louisiana, United States
• Local Institution - 127 — Jacksonville, North Carolina, United States
• Local Institution - 290 — Oklahoma City, Oklahoma, United States
• Local Institution - 143 — Portland, Oregon, United States
• Local Institution - 179 — Germantown, Tennessee, United States
• Local Institution - 122 — Dallas, Texas, United States
• Local Institution - 152 — Camperdown, New South Wales, Australia
• Local Institution - 751 — Vitebsk, Belarus
• Local Institution - 600 — Ghent, Belgium
• Local Institution - 601 — Leuven, Belgium
• Local Institution - 450 — Sofia, Bulgaria
• Local Institution - 459 — Sofia, Bulgaria
• Local Institution - 451 — Sofia, Bulgaria
• Local Institution - 264 — Lindsay, Ontario, Canada
• Local Institution - 611 — Osijek, Croatia
• Local Institution - 342 — Klatovy, Czechia
• Local Institution - 337 — Prague, Czechia
• Local Institution - 535 — Berlin, Germany
• Local Institution - 525 — Berlin, Germany
• Local Institution - 545 — Frankfurt, Germany
• Local Institution - 643 — Athens, Greece

Full record on ClinicalTrials.gov

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