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.

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000100-20-DE

Enrollment

Registered

2017-03-09

Start date

2017-06-06

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

Product Name: BI 655130 Product Code: BI 655130 Pharmaceutical Form: Solution for infusion INN or Proposed INN: BI 655130 Current Sponsor code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY AN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 18 – 65 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 (e.g. integrin inhibitors, IL12/23 or IL23 inhibitors , any other 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

Design outcomes

Primary

Measure	Time frame
Main Objective: This trials aims to understand the mechanism of action of BI655130 in patients with ulcerative colitis (UC);Secondary Objective: Explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment ;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	—

Measure

Time frame

Main Objective: This trials aims to understand the mechanism of action of BI655130 in patients with ulcerative colitis (UC);Secondary Objective: Explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment ;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

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

Countries

Belgium, Germany, United Kingdom

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim GmbH & Co. KG

clintriage.rdg@boehringer-ingelheim.com+18002430127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026