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
2 other identifiers
interventional
22
6 countries
16
Brief Summary
The objectives of this trial are safety and efficacy (proof-of-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. 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 (Tumor necrosis factor inhibitor) 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2017
Typical duration for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedStudy Start
First participant enrolled
June 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2020
CompletedResults Posted
Study results publicly available
October 7, 2021
CompletedOctober 16, 2025
October 1, 2025
2.8 years
April 13, 2017
September 15, 2021
October 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Participants With Endoscopic Improvement (MCS mESS ≤1) at Week 12
Proportion of participants with endoscopic improvement (Mayo clinical score (MCS) modified endoscopic sub-score (mESS) ≤1) at Week 12 was reported. The endoscopic improvement (mucosal healing) was defined as the Mayo clinical score (MCS) modified endoscopic sub-score (mESS) ≤ 1 point. The MCS mESS ranged from 0 (normal) to 3 (severe disease). The mESS was assessed by a central reader who was independent from the investigator. The 95% confidence intervals (in the descriptive statistics part) were calculated using the method of Wilson.
At Week 12
Secondary Outcomes (4)
Proportion of Participants With Total Clinical Remission (tCR) Based on Total Mayo Clinical Score at Week 12
At Week 12
Proportion of Participants With Histological Remission at Week 12
At Week 12
Proportion of Participants With Clinical Remission (CR) Based on Mayo Clinical Score at Week 12
At Week 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
From first does of study medication until end of the follow-up period, up to 36 weeks.
Study Arms (2)
Spesolimab
EXPERIMENTAL1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively).
Placebo
PLACEBO COMPARATORMatching placebo was administered via intravenous infusion over 12 weeks of treatment.
Interventions
Eligibility Criteria
You may qualify if:
- years at screening and randomisation
- Diagnosis of ulcerative colitis \>= 5 months prior to screening
- Receiving TNFi treatment with doses (i.e. dose and dosing interval) unchanged for \>= 4 months (Infliximab) or \>= 2 Monaten (Adalimumab or Golimumab) prior to randomisation
- Mild or moderate disease activity, defined as total Mayo Score (MCS) (\<= 10)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Aalborg Sygehus Syd
Aalborg, 9100, Denmark
Sanos Clinic
Herlev, 2730, Denmark
Odense University Hospital
Odense, 5000, Denmark
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Amsterdam UMC, Locatie AMC
Amsterdam, 1105 AZ, Netherlands
Akershus Universitetssykehus HF
Lørenskog, N-1478, Norway
Hospital Puerta de Hierro
Majadahonda, 28222, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Politècnic La Fe
Valencia, 46026, Spain
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
Whiston Hospital
Prescot, L35 5DR, United Kingdom
Related Publications (1)
Lebwohl MG, Thoma C, Haeufel T. Spesolimab use in generalised pustular psoriasis flares - Authors' reply. Lancet. 2024 Aug 31;404(10455):847-848. doi: 10.1016/S0140-6736(24)01557-5. No abstract available.
PMID: 39216969DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2017
First Posted
April 21, 2017
Study Start
June 7, 2017
Primary Completion
March 26, 2020
Study Completion
September 16, 2020
Last Updated
October 16, 2025
Results First Posted
October 7, 2021
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share
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