1368.10: BI655130 add-on in patients with UC during TNFi therapy
Research type
Research Study
Full title
Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy
IRAS ID
222332
Contact name
Peter Irving
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2016-004572-21
Clinicaltrials.gov Identifier
33588, NIHR CRN
Duration of Study in the UK
1 years, 0 months, 15 days
Research summary
The investigational drug, BI 655130 belongs to a class of drugs known as humanized monoclonal antibodies specific to the IL36 receptor, which is involved in the inflammation process observed in ulcerative colitis (UC) and works by stopping the effect of a protein called IL-36 involved in the development of UC.
This trial compares the effects of BI 655130 with a placebo as add-on therapy to a TNF inhibitor that the patients are already receiving. This is a double- blind study in which patients will be randomised to receive either BI 655130 or a placebo. Eligible patients will be randomised to receive treatment in a 2:1 ratio (BI655130 : placebo).
There are 11 planned study visits, divided into screening (two visits), treatment (five visits) and follow up(four visits), phases over a period of 36 weeks. The duration of the treatment phase will be 12 weeks with drug application at week 0, 4 and 8. The patients will then be followed up for 24 weeks. Each visit will take approximately 2-8 hours to complete depending on what has to be done. Visits that require study drug administration will last approximately 6 hours. Visits that require colonoscopy or sigmoidoscopy will last approximately 6-8 hours.
Patients will be required to provide stool samples, often collected at home and keep a daily diary on a study provided smartphone to record their bowel movements and rectal bleeding. Patients will also record the medications that they take for UC everyday. Blood samples will be taken at every visit. Patients will have colonoscopies or sigmoidoscopies with biopsies taken at three visits and will answer questionnaires regarding their wellbeing and disease during several study visits.
Approximately five (5) people will participate in this trial in The United Kingdom and approximately 30 participants worldwide.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0573
Date of REC Opinion
7 Jun 2017
REC opinion
Further Information Favourable Opinion