GED-0301-CD-003 - ACTIVE CROHN’S DISEASE
Research type
Research Study
Full title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF MONGERSEN (GED-0301) FOR THE TREATMENT OF ADULT AND ADOLESCENT SUBJECTS WITH ACTIVE CROHN’S DISEASE
IRAS ID
220006
Contact name
Jeffrey Butterworth
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2015-001924-40
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1190-4462, Universal Trial Number (UTN)
Duration of Study in the UK
1 years, 4 months, 30 days
Research summary
The purpose of this clinical research study is to test the effects of an investigational study medication, GED-0301, in order to find out if GED-0301 can or cannot improve the symptoms of Crohn’s disease. The study will test GED-0301, given in 2 tablet strengths to adult and adolescent subjects (aged 12 to 17 years, inclusive), compared to placebo. The placebo is a “sugar pill” that contains no active study medication (or GED-0301), but looks exactly like the active study medication tablet. This study will test how well the body tolerates GED-0301 and the effect that GED-0301 has on the symptoms of Crohn’s disease. This is a phase 3 study, which means that the investigational study medication has been tested for safety and is now being tested in a larger number of patients.
Subjects will participate for a maximum of 20 weeks in this study: up to 4 weeks in the Screening Period; 12 weeks in the Double-blind Treatment Period; and 4 weeks in the Follow-up Period.About 798 subjects worldwide will take part in this study.
All subjects who complete the study will have the option to enter a long-term active-treatment study under protocol GED-0301-CD-004 at the Week 12 Visit.
This study is being organised by Celgene Corporation.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0172
Date of REC Opinion
17 May 2017
REC opinion
Further Information Favourable Opinion