RPC01-3204: Open Label Extension study of Ozanimod for Crohn’s Disease
Research type
Research Study
Full title
A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease
IRAS ID
_244752
Contact name
Peter Irving
Contact email
Sponsor organisation
Celgene International II Sàrl
Eudract number
2017-004295-55
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Not available, Not available
Duration of Study in the UK
5 years, 0 months, 18 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 1200 participants worldwide will take part in this study. Participants will be assigned to receive active drug. The participants and study doctors will know subjects are receiving active drug. This study will continue until the end of 2022, until marketing authorization is obtained in the subject’s country, or until the sponsor discontinues the development program, whichever comes first. 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/0724
Date of REC Opinion
18 May 2018
REC opinion
Unfavourable Opinion