1368-0005 BI 655130 in patients with active ulcerative colitis
Research type
Research Study
Full title
A Phase II/III Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy.
IRAS ID
240085
Contact name
Peter Irving
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2017-004230-28
Duration of Study in the UK
2 years, 7 months, 11 days
Research summary
This study is a Phase II/III Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy. The main purpose of this study is to investigate how BI 655130 works in patients with active ulcerative colitis (UC). For this goal, the safety and tolerability of 12 weeks of BI 655130 treatment will be measured. In addition, pharmacokinetics and biomarkers will be studied in blood, stool and colon biopsies during treatment.
It is estimated that approximately 39 people will participate in this study in the UK and approximately 160 participants worldwide. Each patients participation in the study will last approximately 29 weeks and require approximately 8 visits to the study clinic.
This study is in two distinct parts but with identical study populations, study endpoints and visit schedules.
Part 1: involves three active dose groups and a placebo group; Part 2: involves two active dose groups and a placebo group. Part 2 will begin recruiting following a short break after Part 1 is completed during which the part 2 dose regimens will be confirmed.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/0381
Date of REC Opinion
13 Apr 2018
REC opinion
Further Information Favourable Opinion