A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab
NCT ID: NCT06241573
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
39 participants
INTERVENTIONAL
2024-05-08
2025-04-11
Brief Summary
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The purpose of this study is to find out how well people tolerate spesolimab and whether it helps people with HS in the long-term. For about 1.5 years, participants get spesolimab injections under the skin every 2 weeks.
Participants are in the study for about 2 years. During this time, participants have 41 visits. 24 visits are done at the study site. 17 visits can be done by video call at the participant's home. At study visits, doctors check the severity of the participant's HS and collect information on any health problems of the participants.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Patients treated in Part I of parent trial 1368-0098 (NCT05819398)
Spesolimab
Spesolimab
Patients treated in Part II of parent trial 1368-0098 (NCT05819398)
Spesolimab
Spesolimab
Patients treated in parent trial 1368-0100
Spesolimab
Spesolimab
Interventions
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Spesolimab
Spesolimab
Eligibility Criteria
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Inclusion Criteria
2. Participants must be within the defined Residual Effect Period corresponding to 16 weeks since last spesolimab administration.
3. Participants who have completed treatment in the parent hidradenitis suppurativa (HS) spesolimab trial (1368-0098 (NCT05819398) or 1368-0100) without premature discontinuation and are willing and able to continue treatment in this trial.
4. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
Exclusion Criteria
2. Use of any drug considered by the investigator likely to interfere with the safe conduct of the trial since the last visit of the parent trials.
3. Use of immunomodulatory biologics or investigational agents since the last visit of the parent trials.
4. Participants who require / intend to use certain restricted medications such as immunomodulatory biologics or other investigational drugs/devices during the course of the trial.
5. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis. The corresponding laboratory tests will be performed at Visit 1. A participant can be re-screened if the participant was treated and is cured from the acute infection.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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First OC Dermatology
Fountain Valley, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Integrative Skin Science and Research-Sacramento-69402
Sacramento, California, United States
Clinical Trials Research Institute
Thousand Oaks, California, United States
STAT Research
CABA, , Argentina
Hospital Italiano de Buenos Aires
CABA, , Argentina
Hospital Alemán
Capital Federal, , Argentina
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Medical Center "Kordis"
Pleven, , Bulgaria
ASMC-IPSMC-skin and Veneral Diseases
Sofia, , Bulgaria
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, Canada
Guelph Dermatology Research
Guelph, Ontario, Canada
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario, Canada
HOP Privé Antony
Antony, , France
HOP Edouard Herriot
Lyon, , France
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
Hautmedizin Saar
Merzig, , Germany
Kurume University Hospital
Fukuoka, Kurume, , Japan
Ogaki Municipal Hospital
Gifu, Ogaki, , Japan
The University of Tokyo Hospital
Tokyo, Bunkyo-ku, , Japan
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, , Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, , Japan
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, , Lithuania
Vilnius University Hospital, Santariskiu
Vilnius, , Lithuania
Hospital Pulau Pinang-Pulau Pinang-21953
Georgetown Pulau Pinang, , Malaysia
Hospital Sultan Ismail
Johor Bahru, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
Sunway Medical Centre
Selangor Darul Ehsan, , Malaysia
Non-Public Health Care Facility LABDERM
Ossy, , Poland
Provita Clinic
Warsaw, , Poland
Royalderm
Warsaw, , Poland
National University Hospital-Singapore-42005
Singapore, , Singapore
Seoul National University Hospital
Seoul, , South Korea
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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Related Links
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Related Info
Other Identifiers
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2023-508377-82-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1300-2310
Identifier Type: REGISTRY
Identifier Source: secondary_id
1368-0130
Identifier Type: -
Identifier Source: org_study_id
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