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Completed

NCT Number: NCT03100864

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

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

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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UZ Leuven, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

spesolimab

Drug

12 weeks treatment

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

    Time frame: 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 outcomes

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

    Time frame: 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).

  2. Percent Change in Faecal Calprotectin From Baseline to Week 12

    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 (day 85).

  3. Percent Change in Faecal Lactoferrin From Baseline to Week 12

    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 (day 85).

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

    Time frame: 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.

  5. Number of Patients With Drug Related Adverse Events (AEs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2017
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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