A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy.

Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004572-21-DK

Enrollment

Registered

2017-03-09

Start date

2017-06-07

Completion date

Unknown

Last updated

2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

Product Name: BI 655130 Product Code: BI 655130 Pharmaceutical Form: Solution for infusion INN or Proposed INN: BI 655130 Current Sponsor code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY AN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 18 – 75 years at screening and randomisation - Diagnosis of ulcerative colitis = 5 months prior to screening - ReceivingTNFi treatment with doses unchanged for =4 months (infliximab) or = 2 months (adalimumab and golimumab) prior to randomisation - Mild or moderate disease activity, defined as total Mayo Score (MCS) (=10) - Further criteria apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - Prior use of more than two different TNF inhibitors or vedolizumab - Extensive colonic resection - Evidence of infection with C. difficile or other intestinal pathogen <28 days prior to screening - Active or latent tuberculosis - Further criteria apply

Design outcomes

Primary

Measure	Time frame
Main Objective: This trial aims to prove the concept of induction of mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite pre-existing TNFi treatment.;Secondary Objective: This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to achieve the similar exposures as the highest exposures tested and found safe and tolerable in preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing TNFi treatment. Secondary and further objectives include assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help understand BI 655130`s mode of action.;Primary end point(s): 1) Mucosal healing (MCS mESS =1) ;Timepoint(s) of evaluation of this end point: 1) 12 weeks	—

Measure

Time frame

Main Objective: This trial aims to prove the concept of induction of mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite pre-existing TNFi treatment.;Secondary Objective: This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to achieve the similar exposures as the highest exposures tested and found safe and tolerable in preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing TNFi treatment. Secondary and further objectives include assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help understand BI 655130`s mode of action.;Primary end point(s): 1) Mucosal healing (MCS mESS =1) ;Timepoint(s) of evaluation of this end point: 1) 12 weeks

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Secondary

Measure	Time frame
Secondary end point(s): 1) Treatment emerging adverse events 2) Histological remission (Robarts (RHI) score =6) 3) Clinical remission based on Mayo score (total MCS =2 points, and all subscores =1 point) 4) Modified clinical remission based on Mayo score (total modified MCS =2 and: RBS=0, Stool Frequency Score (SFS) =0 or 1 and drop =1 from baseline, AND mESS =1) ;Timepoint(s) of evaluation of this end point: 1) 28 weeks, throughout treatment and follow-up period of study 2) 12 weeks 3) 12 weeks 4) 12 weeks	—

Measure

Time frame

Secondary end point(s): 1) Treatment emerging adverse events 2) Histological remission (Robarts (RHI) score =6) 3) Clinical remission based on Mayo score (total MCS =2 points, and all subscores =1 point) 4) Modified clinical remission based on Mayo score (total modified MCS =2 and: RBS=0, Stool Frequency Score (SFS) =0 or 1 and drop =1 from baseline, AND mESS =1) ;Timepoint(s) of evaluation of this end point: 1) 28 weeks, throughout treatment and follow-up period of study 2) 12 weeks 3) 12 weeks 4) 12 weeks

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Countries

Denmark, Germany, Netherlands, Norway, Spain, United Kingdom

Contacts

Public ContactClinical Trial Application Officer

Boehringer Ingelheim Danmark A/S

RAhuman.dk@boehringer-ingelheim.com+4539158888

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026