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RPC01-3101: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

Clinical Trial Details

This clinical trial is for men and women between 18 to 75 years of age who are infected with moderate to severe ulcerative colitis and have had a colonoscopy (an examination of the bowel with a thin, flexible telescope) or sigmoidoscopy (like colonoscopy, but using a shorter telescope) during the last two years or agree to have it done at the beginning of the study 
    
Celgene, the sponsor of this study, and your study doctor (the study site) are studying the experimental drug called RPC1063 (Ozanimod). The purpose of this study is to help determine if RPC1063 (Ozanimod) is safe, effective and tolerable in treating ulcerative colitis. It will also measure how the study drug, RPC1063(Ozanimod) is absorbed, distributed, broken down and eliminated by the body. This process is known as pharmacokinetics (PK). 
    
This study is double-blinded, which means that neither you nor your study doctor or the study staff will know which study drug you are receiving. However, the study drug you receive will be made known in the case of an emergency. 
    
If you decide to participate, you will be randomized, like the flipping of a coin, to receive one of two study interventions/study drugs: RPC1063 (Ozanimod) or a placebo. RPC1063 (Ozanimod) will be given to you in a capsule form and should be taken by mouth every morning. A placebo is a capsule that looks like the study drug but contains no active drug. The placebo is made up of 92% glycerin (a simple sugar) and 8% saline (salt water), with food coloring to match the color of RPC1063, that is put into a capsule. 
    
The study consists of three parts: the Screening period (1 - 35 days), the Induction Period (10 weeks) and the Maintenance Period (42 weeks). Overall you will receive study drug for a maximum period of 52 weeks. 

Key Eligibility: 
  • Men and women age 18 to 75 years old
  • Moderate to Severe Ulcerative Colitis
  • Have had a colonoscopy or sigmoidoscopy during the last two years or agree to have it done at the beginning of the study
  • Detailed eligibility reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

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

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1508016458

Sponsor:

RPC01-3101

Status

Open to Enrollment

Sponsor