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 2

Completed

• Conditions: Colitis, Ulcerative
• Interventions: Drug: Spesolimab

• Registration Number: NCT03100864
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-04
• Study Start: 2017-05-22
• Primary Completion: 2019-08-05
• Study Completion: 2019-10-24
• Results First Submitted: 2020-10-22
• Results First Submitted QC: 2020-10-22
• Status Verified: 2020-11
• Results First Posted: 2020-11-16
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spesolimab	Spesolimab	-

Primary Outcome Measures

Name	Time	Method
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	Measurements done at baseline (day -8 to -6), day 1, day 4, day 15, day 57 and day 85 (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.

Secondary Outcome Measures

Name	Time	Method
Percent Change in C-reactive Protein (CRP) From Baseline to Week 12	Measurements done at baseline (day -8 to -6) and week 12 (day 85).	Percent change in C-reactive protein (CRP) from baseline to Week 12 (day 85).
Percent Change in Faecal Lactoferrin From Baseline to Week 12	Measurements done at baseline (day -8 to -6) and week 12 (day 85).	Percent change in faecal lactoferrin from baseline to week 12 (day 85).
Number of Participants With Clinical Remission (Defined as Mayo Score ≤2 Points, and All Subscores ≤1 Point) at Week 12	Week 12 (day 85) following start of treatment.	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.
Percent Change in Faecal Calprotectin From Baseline to Week 12	Measurements done at baseline (day -8 to -6) and week 12 (day 85).	Percent change in faecal calprotectin from baseline to week 12 (day 85).
Number of Patients With Drug Related Adverse Events (AEs)	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.	Number of patients with drug related adverse events (AEs) during the on-treatment period.

Trial Locations

Locations (4)

Addenbrooke's Hospital; 🇬🇧 Cambridge, United Kingdom

Universitätsklinikum Schleswig-Holstein, Campus Kiel; 🇩🇪 Kiel, Germany

UZ Leuven; 🇧🇪 Leuven, Belgium

Asklepios Kliniken Westklinikum Hamburg; 🇩🇪 Hamburg, Germany