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

NCT03100864 | Completed Phase 2 Results DMC

• 2 other identifiers: 1368-00042017-000100-20
• Study Type: interventional
• Target: 8
• Locations: 3 countries
• Sites: 4

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

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 Faecal Calprotectin 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

  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

  Week 12 (day 85) following start of treatment.

• 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.

Study Arms (1)

Spesolimab

EXPERIMENTAL

Drug: Spesolimab

Interventions

Spesolimab DRUG

12 weeks treatment

Spesolimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (4)

UZ Leuven

Leuven, 3000, Belgium

Location

Asklepios Kliniken Westklinikum Hamburg

Hamburg, 22559, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

spesolimab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 4, 2017
• Study Start: May 22, 2017
• Primary Completion: August 5, 2019
• Study Completion: October 24, 2019
• Last Updated: October 16, 2025
• Results First Posted: November 16, 2020

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); BE (1); DE (2)