RPC01-3102: A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis. (Extension study for RPC01-3101)

Clinical Trial Details

The purpose of this study is to see if long-term use of the investigational drug RPC1063 (ozanimod) is safe and effective for the possible treatment of UC.

RPC1063 is a chemical compound that is thought to act on the immune system by making certain types of white blood cells (lymphocytes including T cells) stay in the lymph nodes and other places in the body, keeping them away from sites of inflammation.

This is a Phase III study, which means that the study drug has already been tested in humans for safety and effectiveness but now is being tested in a larger number of patients

Key Eligibility:

Inclusion Criteria:

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

Exclusion Criteria:

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

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Fatiha Chabouni
(212) 746-5109
fac2005@med.cornell.edu

Primary Investigator(s)

Randy Longman, MD, PhD (UES)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1508016523

ClinicalTrials.gov:

NCT02531126

Status

Open to Enrollment

Age Group

Adult

Disease

Gastrointestinal & Digestive System Diseases

Inflammatory Bowel Disease

Ulcerative Colitis