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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

Primary Purpose

Colitis, Ulcerative

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Spesolimab
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZ Leuven
  • Asklepios Kliniken Westklinikum Hamburg
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • Addenbrooke's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spesolimab

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Percent Change in Faecal Calprotectin From Baseline to Week 12
Percent change in faecal calprotectin from baseline to 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).
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.
Number of Patients With Drug Related Adverse Events (AEs)
Number of patients with drug related adverse events (AEs) during the on-treatment period.

Full Information

First Posted
March 31, 2017
Last Updated
November 30, 2020
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT03100864
Brief Title
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
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
August 5, 2019 (Actual)
Study Completion Date
October 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spesolimab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Spesolimab
Intervention Description
12 weeks treatment
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Measurements done at baseline (day -8 to -6), day 1, day 4, day 15, day 57 and day 85 (week 12).
Secondary Outcome Measure Information:
Title
Percent Change in C-reactive Protein (CRP) From Baseline to Week 12
Description
Percent change in C-reactive protein (CRP) from baseline to Week 12 (day 85).
Time Frame
Measurements done at baseline (day -8 to -6) and week 12 (day 85).
Title
Percent Change in Faecal Calprotectin From Baseline to Week 12
Description
Percent change in faecal calprotectin from baseline to week 12 (day 85).
Time Frame
Measurements done at baseline (day -8 to -6) and week 12 (day 85).
Title
Percent Change in Faecal Lactoferrin From Baseline to Week 12
Description
Percent change in faecal lactoferrin from baseline to week 12 (day 85).
Time Frame
Measurements done at baseline (day -8 to -6) and week 12 (day 85).
Title
Number of Participants With Clinical Remission (Defined as Mayo Score ≤2 Points, and All Subscores ≤1 Point) at Week 12
Description
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.
Time Frame
Week 12 (day 85) following start of treatment.
Title
Number of Patients With Drug Related Adverse Events (AEs)
Description
Number of patients with drug related adverse events (AEs) during the on-treatment period.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Asklepios Kliniken Westklinikum Hamburg
City
Hamburg
ZIP/Postal Code
22559
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trials.boehringer-ingelheim.com/
Description
Related Info

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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

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