RPC01-3203:study of Ozanimod as Maintenance therapy for Crohns Disease
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease
IRAS ID
244615
Contact name
Peter Irving
Contact email
Sponsor organisation
Celgene International II Sàrl
Eudract number
2017-004294-14
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Not available, Not available
Duration of Study in the UK
2 years, 11 months, 17 days
Research summary
This is a phase III study being conducted by Celgene International II Sarl. The purpose of this study is to confirm preliminary results from a previous phase II study that suggests that ozanimod may be safe and effective in treating Crohn’s disease (CD) patients. CD is a chronic inflammatory disorder of the bowels. People with CD often suffer from diarrhoea, abdominal pain, rectal bleeding, weight loss, and fever. Ozanimod is a chemical compound that is thought to act on the immune system by making certain types of white blood cells stay in the lymph nodes thereby keeping them out of circulation and away from sites of inflammation. Approximately 485 participants worldwide will take part in this study. Participants will be randomly assigned to receive active drug or placebo (dummy-pills with no active ingredient). There will be a 1 in 2 chance to receive active drug or placebo. The participants and study doctors will not know which treatment has been assigned. The total time of the study is up to 40 weeks, and an additional 6 week safety follow-up period in the event patients don’t continue into the Open Label Extension (OLE) study. Patients who complete, or experience relapse due to CD at any time during, the Maintenance study will be eligible to enter the OLE study. This study will include a number of examinations, tests, and procedures. The study requires the testing of some biomarkers. Participants also have the option to allow the sponsor to keep their samples for up to 20 years for future research.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/0723
Date of REC Opinion
13 Jul 2018
REC opinion
Further Information Favourable Opinion