A Phase 3 study of Ozanimod as induction therapy for Crohn’s Disease
Research type
Research Study
Full title
Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease
IRAS ID
238635
Contact name
Peter Irving
Contact email
Sponsor organisation
Celgene International II Sàrl
Eudract number
2017-004292-31
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Not available, Not available
Duration of Study in the UK
2 years, 7 months, 1 days
Research summary
This phase III study is being conducted by Celgene International II Sarl. The purpose of this study is to confirm the preliminary results from a previous (phase II) study that suggests that ozanimod, may be safe and effective in treating patients with Crohn’s Disease (CD). CD is a chronic inflammatory disorder of the bowels. People with CD often suffers 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 that stays in the lymph nodes and other places in the body, keeping them away from sites of inflammation.
Approximately 600 participants worldwide will be taking part in this study. Participants will be randomly assigned to receive an active drug or placebo (dummy-pills with no active ingredient). There will be a 2 in 3 chance to receive active drug and 1 in 3 chance to receive a placebo. The participants and study doctors will not know which treatment has been assigned.
The total time in the study is up to 23 weeks, including a screening period, and a treatment period. Once treatment ends, participants may be invited to participate in a further study or will be asked to return for a Safety Follow-Up visit. Upon completion of induction study the participants can participate in a maintenance study or an open label extension study or can return for the safety Follow-up visit.
This study will include a number of examinations, tests and procedures. Samples will also be tested for biomarkers (proteins that tells how the drug is working in the body) and participants may choose to take part in the additional genetic testing.
Participants may allow the Sponsor to keep the samples for up to 20 years for future research.REC name
London - City & East Research Ethics Committee
REC reference
18/LO/0722
Date of REC Opinion
13 Jul 2018
REC opinion
Further Information Favourable Opinion