RPC01-3101 True North study
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
IRAS ID
180885
Contact name
Syed Samiul Hoque
Contact email
Sponsor organisation
Celgene International II Sàrl (CIS II)
Eudract number
2015-000319-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 1 days
Research summary
Ulcerative colitis (UC) is a chronic inflammatory disorder of the bowels. People with UC suffer from diarrhea, rectal bleeding, weight loss, abdominal pain, and fever.
The purpose of this study is to see whether RPC1063 (study drug) is safe and effective for the possible treatment of UC. To do this, a comparison will be made between patients who receive study drug and patients who receive placebo (a ‘dummy treatment’ that looks like the study drug but contains no active ingredient).
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.
The study drug 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. The study drug is an investigational drug, which means that not all information is clear on how the drug works in your body and it is not yet approved for use. At the current time, there are not enough results available to be sure whether this drug will help or improve patients' health.Participants will receive 1 or 2 capsules of the study drug or placebo, to be taken by mouth every morning as directed by their study doctor.
Around 1,697 patients, in approximately 250 study centers across North America, Europe, Asia Pacific, South America, and South Africa will be asked to take part in this study, and 900 patients will be eligible to take part in the study.REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/1175
Date of REC Opinion
10 Aug 2015
REC opinion
Further Information Favourable Opinion