Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients
NCT ID: NCT03135548
Last Updated: 2025-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2017-05-30
2018-11-14
Brief Summary
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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 (low dose)
Spesolimab (low dose)
12 weeks treatment
Spesolimab (high dose)
Spesolimab (high dose)
12 weeks treatment
Placebo
Placebo
12 weeks treatment
Interventions
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Spesolimab (low dose)
12 weeks treatment
Placebo
12 weeks treatment
Spesolimab (high dose)
12 weeks treatment
Eligibility Criteria
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Inclusion Criteria
* Palmoplantar Pustulosis
Exclusion Criteria
* Active or latent tuberculosis
18 Years
65 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Dr. Irina Turchin PC Inc.
Fredericton, New Brunswick, Canada
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Aarhus University Hospital, Skejby
Aarhus, , Denmark
Gentofte Hospital
Hellerup, , Denmark
Bispebjerg og Frederiksberg Hospital
København NV, , Denmark
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
TFS Trial Form Support GmbH
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Ospedale San Giovanni di Dio
Cagliari, , Italy
Pol. Universitario Tor Vergata
Roma, , Italy
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Sahlgrenska US, Göteborg
Gothenburg, , Sweden
Karolinska Univ. sjukhuset
Stockholm, , Sweden
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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2016-004573-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1368-0015
Identifier Type: -
Identifier Source: org_study_id
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