1368.4 Exploratory trial of BI655130 in patients with active UC
Research type
Research Study
Full title
Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC)
IRAS ID
222329
Contact name
Arthur Kaser
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd
Eudract number
2017-000100-20
Clinicaltrials.gov Identifier
33596, NIHR Number
Duration of Study in the UK
1 years, 1 months, 22 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 is an open label, single arm, phase II exploratory trial with the primary objective of understanding the mechanism of action of BI655130 in patients with UC.
The trial includes a screening period, a 12-week treatment period and a safety follow-up period of 16 weeks. Safety monitoring wil be done for 20 weeks after the last dose of BI 655130, which is administered at Week 8.
Patients should be on stable doses of conventional treatment for their disease.
Administration of 1200mg BI 655130 intravenously will take place every four weeks (Day 1, Week 4 and Week 8).
During treatment phase, sequential sigmoidoscopies will be conducted to collect biopsies for evaluation of endpoint variables. Also, blood and stool samples will be collected at various visits, and data will be correlated with the results from biopsies. Patients will also be required to keep a stool diary.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
17/EE/0220
Date of REC Opinion
17 Jul 2017
REC opinion
Further Information Favourable Opinion