GED-0301-CD-004 Ph3 extension study for subjects with Crohn’s Disease
Research type
Research Study
Full title
A PHASE 3, LONG-TERM ACTIVE TREATMENT EXTENSION STUDY OF MONGERSEN (GED-0301) IN SUBJECTS WITH CROHN’S DISEASE
IRAS ID
193858
Contact name
Daniel Gaya
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2015-001963-37
Clinicaltrials.gov Identifier
IND Number, 123278
Duration of Study in the UK
5 years, 3 months, 29 days
Research summary
The purpose of this clinical research study is to test the long-term effects of an investigational (being tested) study medication, named mongersen or GED-0301. This study is designed to find out how well the body tolerates GED-0301 over a long period of time, and if GED-0301 can or cannot improve the symptoms of Crohn’s disease over a period of up to 4 years. The study medication, GED-0301, has not been approved for the treatment of Crohn’s disease and its use in this study is investigational.
A computer program will determine which study treatment the subject had received in the original Phase 3 GED-0301 study and from this will decide which of the 5 study treatment groups, GED-0301 with or without placebo (a sugar pill that contains no study medication but looks exactly like the study medication tablet) they will be assigned to in this GED-0301 extension study. The computer makes this decision based on whether the subject had improvement or no improvement in the original GED-0301 treatment study.
This study is double-blinded (neither the subject or study team will know which treatment the subject is receiving) for the entire 208 weeks for the purpose of preserving the blind of the subject’s treatment allocation in the original Phase 3 GED-0301 study.
The maximum time a subject will be in the study is 216 weeks or 4 years and 2 months for a total of 55 visits.
The study will consist of 3 periods:
- Screening Period – up to 4 weeks (ie, 1 day to 28 days depending on when long-term
active treatment is available for the subject at the study centre)
- Long-term Active Treatment Period – 208 Weeks (Week 0 to Week 208)
- Follow-up Period – 4 weeks (ie, no investigational product [IP] taken)REC name
West of Scotland REC 1
REC reference
16/WS/0005
Date of REC Opinion
15 Mar 2016
REC opinion
Further Information Favourable Opinion