Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

a study on Inflammatory Bowel Disease

Summary

for people ages 18–75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients diagnosed with 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

Details

The trial is an open label extension study. Eligible patients from the RPC01-3101 trial diagnosed with moderate to severe ulcerative colitis will be enrolled to receive study medication for up to 5 years or until marketed approval.

Keywords

Ulcerative Colitis Colitis Ulcer Colitis, Ulcerative

Eligibility

You can join if…

Open to people ages 18–75

  • Previous participation on a trial of RPC1063 for ulcerative colitis (UC) and may benefit from continued treatment

You CAN'T join if...

  • Require initiation of other therapies used in the treatment of UC
  • Pregnant, lactating, or have a positive serum pregnancy test
  • Have clinically relevant cardiovascular conditions or other relevant disease that would put the patient at risk or make interpretation of the trial difficult

Locations

  • University of California at San Francisco (PARENT) accepting new patients
    San Francisco, California, 94115, United States
  • High Desert Gastroenterology, Inc. accepting new patients
    Lancaster, California, 93534, United States
  • Facey Medical Foundation (Parent) accepting new patients
    Mission Hills, California, 91345, United States
  • Anaheim Clinical Trials accepting new patients
    Anaheim, California, 92801, United States
  • Alliance Clinical Research accepting new patients
    Oceanside, California, 92056, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT02531126
Phase
Phase 3
Lead Scientist
Jonathan Terdiman
Study Type
Interventional
Last Updated
May 2017