Phase III, Fixed-dose, combination RHB-104, Moderately Active Crohn's
Research type
Research Study
Full title
A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately Active Crohn’s Disease
IRAS ID
172216
Contact name
Stuart Bloom
Contact email
Sponsor organisation
RedHill Biopharma Ltd
Eudract number
2014-004108-31
Duration of Study in the UK
2 years, 11 months, 26 days
Research summary
This study is a phase III study for those living with Moderately Active Crohn’s Disease (CD). The study involves a study drug, RHB-104, which is a combination of 3 antibiotics that are all approved for the treatment of various bacterial infections, with activity against specific mycobacteria- a potential cause of CD. Study drug will be compared to a placebo treatment (tablet that contains no medication) to find out which is better for treating active CD. The study is a randomized, double-blind study, meaning neither patient nor study staff will know who has the study drug and who has the placebo. It will involve 360 participants across 100 research sites in 12 countries.
The study will last for 60 weeks and participants will be expected to undertake 13 visits to the research site within this period.
Screening will be undertaken before the first dose of the study drug is given and various blood tests, physiology tests and questionnaires will be asked of the participant throughout the length of the trial; to include but not exclusive to ECG, vital signs, physical examinations and the collection of CD information in the form of a diary.
Participants will be asked to self-administer the study drug at home and be given full guidance on what to take and when.Eligible patients must be over 18, have diagnosed active moderate CD involving the ileum and/or colon that is treated with a marketed therapy, willing to provide written informed consent (IC) and prepared to take certain contraception methods.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0197
Date of REC Opinion
8 Jun 2015
REC opinion
Further Information Favourable Opinion