GED-0301-CD-002 PhIII study for subjects with Active Crohn’s Disease
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-controlled, Multicentre study to investigate the efficacy and safety of Mongersen (GED-0301) for the treatment of subjects with Active Crohn's Disease
IRAS ID
193859
Contact name
Daniel Gaya
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2015-001925-18
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND number, 123278
Duration of Study in the UK
1 years, 7 months, 24 days
Research summary
The purpose of this study is to determine whether GED-0301, is a safe, effective and tolerable treatment for patients with active Crohn’s Disease (CD).
GED-0301 is an experimental drug which means it has not been approved by the health authorities for treatment of Crohn’s Disease. GED-0301 and placebo are administered orally by tablet.
The screening period is up to 28 days during which patient eligibility will be determined. After screening the study will be divided into 3 treatment groups and 1 placebo.
Group 1 will receive GED-0301 160 mg once daily for 12 weeks; followed by placebo once daily for 4 weeks; followed by alternating GED-0301 160 mg once daily for 4 weeks and placebo once daily for 4 weeks, until the Week 52 Visit;
Group 2 subjects will receive GED-0301 160 mg once daily for 12 weeks; followed by placebo once daily for 4 weeks; followed by alternating GED-0301 40 mg once daily for 4 weeks and placebo once daily for 4 weeks, until the Week 52 Visit.
Group 3 subjects will receive GED-0301 160 mg once daily for 12 weeks; followed by continuous GED-0301 40 mg once daily, until the Week 52 Visit.
Group 4 will receive Placebo once daily until the Week 52 Visit.The study duration, will be up to 60 weeks (4 weeks in the Screening Period, 52 weeks in the Double-blind Treatment Period, 4 weeks in the Follow-up Period). The total length of the treatment period will be 52 weeks.
If eligible patients can opt to go into the Long-term Active- treatment Study after week 12 up until week 52 The End of Study is defined as the date of the last visit of the last subject to complete the post-treatment follow-up,Overall approximately 1064 patients will be recruited from approximately 512 sites worldwide.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
16/ES/0001
Date of REC Opinion
24 Feb 2016
REC opinion
Further Information Favourable Opinion