A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy.

Phase 1

• Conditions: Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy; MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-004572-21-DE
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-24
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- 18 – 75 years at screening and randomisation
- Diagnosis of ulcerative colitis =5 months prior to screening
- ReceivingTNFi treatment with doses unchanged for =4 months
(infliximab) or =2 months (adalimumab and golimumab) prior to
randomisation
- Mild or moderate disease activity, defined as total Mayo Score (MCS) (=10)
- Further criteria apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Prior use of more than two different TNF inhibitors or vedolizumab
- Extensive colonic resection
- Evidence of infection with C. difficile or other intestinal pathogen <28 days prior to screening
- Active or latent tuberculosis
- Further criteria apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objectives of this trial are safety and efficacy (proof-of-concept) of induction of mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite pre-existing TNFi treatment.;Primary end point(s): 1) Mucosal healing (MCS mESS =1) ;Timepoint(s) of evaluation of this end point: 1) 12 weeks;Secondary Objective: This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to achieve the similar exposures as the highest exposures tested and found safe and tolerable in preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing TNFi treatment. Secondary and further objectives include assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help understand BI 655130`s mode of action.

Secondary Outcome Measures

Name	Time	Method
<br> Timepoint(s) of evaluation of this end point: 1) 28 weeks, throughout treatment and follow-up period of study<br> 2) 12 weeks<br> 3) 12 weeks<br> 4) 12 weeks<br> ;<br> Secondary end point(s): 1) Treatment emerging adverse events<br> 2) Histological remission (Robarts (RHI) score =6)<br> 3) Clinical remission based on Mayo score (total MCS =2 points, and all<br> subscores =1 point)<br> 4) Modified clinical remission based on Mayo score (total modified MCS =<br> 2 and: RBS=0, Stool Frequency Score (SFS) =0 or 1 and drop =1 from<br> baseline, AND mESS =1)<br>