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
NCT ID: NCT03123120
Last Updated: 2025-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2017-06-07
2020-09-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Spesolimab
1200 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).
Spesolimab
12 weeks treatment
Placebo
Matching placebo was administered via intravenous infusion over 12 weeks of treatment.
Placebo
12 weeks treatment
Interventions
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Spesolimab
12 weeks treatment
Placebo
12 weeks treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* Extensive colonic resection
* Evidence of infection with C. difficile or other intestinal pathogen \<28 days prior to screening
* Active or latent tuberculosis
18 Years
75 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Aalborg Sygehus Syd
Aalborg, , Denmark
Sanos Clinic
Herlev, , Denmark
Odense University Hospital
Odense, , Denmark
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Amsterdam UMC, Locatie AMC
Amsterdam, , Netherlands
Akershus Universitetssykehus HF
Lørenskog, , Norway
Hospital Puerta de Hierro
Majadahonda, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Politècnic La Fe
Valencia, , Spain
St James's University Hospital
Leeds, , United Kingdom
Guy's Hospital
London, , United Kingdom
Whiston Hospital
Prescot, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2016-004572-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1368-0010
Identifier Type: -
Identifier Source: org_study_id
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