This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients.

Phase 1

• Conditions: Active ulcerative colitis; 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: EUCTR2017-000100-20-GB
• Lead Sponsor: Boehringer Ingelheim Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-14
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- 18 – 75 years at screening
- Diagnosis of UC =3 months prior to screening.
- Moderately to severely active UC as confirmed by Mayo Score =6
- Receiving conventional, non-biologic therapy for UC.
- Negative colon cancer screening
-naive or experienced to TNF antagonists (but have not failed that treatment due to primary non-response or loss of response.)

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 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

-Patients who have previously failed treatment with any TNF antagonist due to primary non-response or loss of response.
- Prior use of any other biological treatment in the past ( integrin inhibitors, IL12/23 or IL23 inhibitors, any investigational biological drugs)
- Extensive colonic resection
- Evidence of infection with C. difficile or other intestinal pathogen < 30 days prior to screening
- Active or latent tuberculosis

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: This trials aims to understand the mechanism of action of BI655130 in patients with ulcerative colitis (UC);<br> Secondary Objective: Explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment<br> <br> ;Primary end point(s): 1) The total number of deregulated genes comparing baseline to post-treatment, analysed by gene expression of mucosal biopsies via RNA sequencing (RNAseq);Timepoint(s) of evaluation of this end point: 1) 12 weeks

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1) Drug related AEs <br> 2) Percent change in CRP <br> 3) Percent change in faecal calprotectin <br> 4) Percent change in faecal lactoferrin <br> 5) Clinical remission based on Mayo Score (Mayo Score =2 with all subscores =1)<br> ;<br> Timepoint(s) of evaluation of this end point: 1) 12 weeks<br> 2) 12 weeks<br> 3) 12 weeks<br> 4) 12 weeks<br> 5) 12 weeks<br>