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

Boehringer Ingelheim8 enrolled

Overview

The primary objective of this trial is to understand the mechanism of action of BI655130 in patients with UC Secondary objectives are to explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colitis, Ulcerative

Interventions

SpesolimabDRUG

12 weeks treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 * Further inclusion criteria apply Exclusion Criteria: * Prior use of any biological treatment in the past (e.g.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 * Further exclusion criteria apply

Locations (4)

UZ Leuven

Leuven, Belgium

Asklepios Kliniken Westklinikum Hamburg

Hamburg, Germany

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, Germany

Addenbrooke's Hospital

Cambridge, United Kingdom

Outcomes

Primary Outcomes

The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12

The total number of deregulated genes comparing baseline to post treatment, analysed by gene expression of mucosal biopsies via RNA sequencing, per time point up to Week 12. A total of 60,675 genes were evaluated, 40,586 genes were included in the differential expression analyses. Based on the raw read count values the DESeq2 method, one of the standard methods to analyse RNAseq data, was used for the gene expression analysis and to identify deregulated genes. A gene was considered deregulated with a FDR (false discovery rate) adjusted p-value \< 0.01 and a fold change ≤ -1.3 or ≥ 1.3.

Time frame: Measurements done at baseline (day -8 to -6), day 1, day 4, day 15, day 57 and day 85 (week 12).

Secondary Outcomes

Percent Change in C-reactive Protein (CRP) From Baseline to Week 12

Percent change in C-reactive protein (CRP) from baseline to Week 12 (day 85).

Time frame: Measurements done at baseline (day -8 to -6) and week 12 (day 85).

Percent Change in Faecal Calprotectin From Baseline to Week 12

Percent change in faecal calprotectin from baseline to week 12 (day 85).

Time frame: Measurements done at baseline (day -8 to -6) and week 12 (day 85).

Percent Change in Faecal Lactoferrin From Baseline to Week 12

Percent change in faecal lactoferrin from baseline to week 12 (day 85).

Time frame: Measurements done at baseline (day -8 to -6) and week 12 (day 85).

Number of Participants With Clinical Remission (Defined as Mayo Score ≤2 Points, and All Subscores ≤1 Point) at Week 12

Number of participants with clinical remission (defined as Mayo score ≤2 points, and all subscores ≤1 point) at Week 12. The Mayo score is a composite disease activity score consisting of 4 items or subscores: stool frequency (relative to normal), rectal bleeding, physician's global assessment (PGA), and endoscopic appearance. The overall range of the Mayo score was 0 to 12 (higher scores being worse) and each subscore had a range of 0 to 3.

Data from ClinicalTrials.gov

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