A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
NCT ID: NCT04762277
Last Updated: 2025-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2021-04-06
2022-04-21
Brief Summary
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Participants are put into 2 groups by chance. One group takes spesolimab. The other group takes placebo. Every participant has twice the chance of being in the spesolimab group than in the placebo group. Participants get spesolimab or placebo as an infusion into a vein every week for the first 3 weeks. Afterwards, they get spesolimab or placebo as injections under the skin every 2 weeks. Placebo infusions and injections look like spesolimab infusions and injections but do not contain any medicine.
Participants are treated in the study for about 3 months. During this time, they visit the study site about 9 times. After completing this part of the study, participants are offered to join another clinical study in which all participants get spesolimab. Participants who cannot join the other study, stay in this study for about 4 more months. During this time, participants do not take spesolimab nor placebo but they visit the study site 2 times to have their health checked.
At study visits, doctors thoroughly check the skin of participants to count lumps (nodules) and boils (abscesses). The results between the spesolimab group and the placebo group are compared after 3 months of treatment. The doctors also regularly check the general health of the participants.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Spesolimab
Spesolimab - solution for infusion
Solution for infusion
Spesolimab- solution for injection
Solution for injection
Placebo
Placebo matching spesolimab - solution for infusion
Solution for infusion
Placebo matching to spesolimab- solution for injection
Solution for injection
Interventions
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Spesolimab - solution for infusion
Solution for infusion
Placebo matching spesolimab - solution for infusion
Solution for infusion
Spesolimab- solution for injection
Solution for injection
Placebo matching to spesolimab- solution for injection
Solution for injection
Eligibility Criteria
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Inclusion Criteria
* Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedures
* Moderate to severe Hidradenitis suppurativa (HS), based on International Hidradenitis Suppurativa Severity Score System (IHS4) criteria, for at least 1 year prior to the baseline visit, as determined by the investigator through participant interview and/or review of the medical history. (If IHS4 scoring is not available, equivalent scoring based on scoring systems as HS-PGA or Hurley are acceptable based on documented investigator assessment)
* HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, perineal)
* Biologic naive or TNF inhibitor (TNFi)-failure for HS
* Inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS in the last 1 year, as per investigator discretion. This is not applicable for TNFi-failure patients
* Total abscess and inflammatory nodule (AN) count of greater than or equal to 5
Exclusion Criteria
* Use of restricted medications as below:
* Topical corticosteroids over HS lesions within 1 week of Visit 2
* Systemic antibiotics within 4 weeks of visit 2
* Systemic non-biologic immunomodulatory and/or immunosuppressive agents use for HS within 4 weeks (or 5 half lives, whichever is longer) of visit 2
* Biologic agents use within 12 weeks or 5 half-lives, whichever is longer, prior to visit 2
* Opioid analgesics within 2 weeks of visit 2
* Live virus vaccine within 6 weeks of visit 2
* Prior exposure to any immunosuppressive biologic other than TNFi for HS
* Prior exposure to Interleukin 36 Receptor (IL-36R) inhibitors including spesolimab
* Treatment with any investigational device or investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to visit 2
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating
* History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Dermatology Research Associates
Los Angeles, California, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Unity Clinical Research
Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
ULB Hopital Erasme
Brussels, , Belgium
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario, Canada
University Hospital Ostrava
Ostrava, , Czechia
CLI Reims Bezannes
Bezannes, , France
HOP Edouard Herriot
Lyon, , France
HOP Larrey
Toulouse, , France
Katholisches Klinikum Bochum gGmbH
Bochum, , Germany
Städtisches Klinikum Dessau
Dessau, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
Ospedali Riuniti di Ancona
Ancona, , Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Haukeland Universitetssykehus
Bergen, , Norway
Nordlandssykehuset HF, Bodø
Bodø, , Norway
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, , Norway
Non-Public Health Care Facility LABDERM
Ossy, , Poland
Cityclinic Medical and Psychological Clinic Matusiak Partnership
Wroclaw, , Poland
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
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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2020-003672-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1368-0052
Identifier Type: -
Identifier Source: org_study_id
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