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)

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 Overview

• Status: Completed
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Drug: Spesolimab

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
• Germany
  • Hamburg, Germany, 22559
    • Asklepios Kliniken Westklinikum Hamburg
  • Kiel, Germany, 24105
    • Universitatsklinikum Schleswig-Holstein, Campus Kiel
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrooke's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spesolimab	Drug: Spesolimab; 12 weeks treatment

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2017
• Primary Completion (Actual): August 5, 2019
• Study Completion (Actual): October 24, 2019

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: October 8, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; spesolimab
• Other Study ID Numbers: 1368-0004; 2017-000100-20 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No