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

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Drug: Spesolimab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spesolimab<br> | Drug: Spesolimab<br>* 12 weeks treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Measurements done at baseline (day -8 to -6), day 1, day 4, day 15, day 57 and day 85 (week 12). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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. | Week 12 (day 85) following start of treatment. | 
| Number of Patients With Drug Related Adverse Events (AEs) | Number of patients with drug related adverse events (AEs) during the on-treatment period. | Date of start of infusion of first study drug (Day 1) till the date of end of infusion of last study drug (day 57) + 140 days at 11:59 p.m., up to 197 days. |