A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
NCT ID: NCT04493424
Last Updated: 2025-10-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
108 participants
INTERVENTIONAL
2020-09-04
2023-05-15
Brief Summary
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The purpose of this study is to find out how safe spesolimab is and whether it helps people with palmoplantar pustulosis in the long-term. Participants are in this study for up to 5 years. During this time they visit the study site every month to get spesolimab injections under the skin.
At study visits, doctors check the severity of participants' palmoplantar pustulosis 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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group
Up to 260 weeks
Spesolimab
Spesolimab
Interventions
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Spesolimab
Spesolimab
Eligibility Criteria
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Inclusion Criteria
* Male or female patients who have completed the treatment period in one of the parent trials without premature discontinuation
* Patients who have obtained an individual health benefit, per investigator judgement (e.g. PPP PGA of 0 (clear) or 1 (almost clear) or other clinical improvement), from treatment in the parent trial
* Women of childbearing potential 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
* Patients who experienced study treatment-limiting adverse events during the parent trial
* Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof
* Patients with congestive heart disease, as assessed by the investigator
* Patient with a transplanted organ (with exception of a corneal transplant \> 12 weeks prior to screening in parent trial) or who have ever received stem cell therapy (e.g., Prochymal)
* Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease (e.g. splenomegaly)
* Any documented active or suspected malignancy or history of malignancy at screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
* Patients who have developed active or severe infective disease and opportunistic infections/infective diseases
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
University of Missouri Health System
Columbia, Missouri, United States
The Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Menter Dermatology Research Institute
Dallas, Texas, United States
University of Utah Health
Murray, Utah, United States
Paratus Clinical Research Woden
Phillip, Australian Capital Territory, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Skin Health Institute Inc
Carlton, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Brussels - UNIV Saint-Luc
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Dr. Irina Turchin PC Inc.
Fredericton, New Brunswick, Canada
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, Canada
The Guenther Dermatology Research Centre
London, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
CCBR Czech a.s.
Pardubice, , Czechia
Univ. Hospital Kralovske Vinohrady
Prague, , Czechia
Sanatorium Prof. Arenebergera
Prague, , Czechia
HOP l'Archet
Nice, , France
HOP Saint-Louis
Paris, , France
HOP Larrey
Toulouse, , France
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
University of Pecs
Pécs, , Hungary
Markusovszky University Teaching Hospital
Szombathely, , Hungary
Fujita Health University Hospital
Aichi, Toyoake, , Japan
Tokyo Dental College Ichikawa General Hospital
Chiba, Ichikawa, , Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, , Japan
Gifu University Hospital
Gifu, Gifu, , Japan
Asahikawa Medical University Hospital
Hokkaido, Asahikawa, , Japan
Takagi Dermatological Clinic
Hokkaido, Obihiro, , Japan
Takamatsu Red Cross Hospital
Kagawa, Takamatsu, , Japan
Sagamihara National Hospital
Kanagawa, Sagamihara, , Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, , Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, , Japan
Tohoku University Hospital
Miyagi, Sendai, , Japan
Shinshu University Hospital
Nagano, Matsumoto, , Japan
Okayama University Hospital
Okayama, Okayama, , Japan
University of the Ryukyus Hospital
Okinawa, Nakagami-gun, , Japan
Nakatsu Dermatology Clinic
Osaka, Osaka, , Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, , Japan
Osaka University Hospital
Osaka, Suita, , Japan
Shiga University of Medical Science Hospital
Shiga, Otsu, , Japan
Jichi Medical University Hospital
Tochigi, Shimotsuke, , Japan
Teikyo University Hospital
Tokyo, Itabashi-ku, , Japan
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, , Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, , Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, , Japan
Barbara Rewerska Diamond Clinic, Krakow
Krakow, , Poland
Dermoklinika medical center, Lodz
Lodz, , Poland
Independent Public Clin.Hosp.no1 Lublin
Lublin, , Poland
Municipal Hospital Complex in Olsztyn
Olsztyn, , Poland
Dermmedica Sp. z o.o., Wroclaw
Wroclaw, , Poland
SBHI Chelyabinsk Reg.Clin.Derma.Dispen.
Chelyabinsk, , Russia
LLC "Medical Center Azbuka Zdorovia"
Kazan', , Russia
Dermatovenereological Dispensary #10, St. Petersburg
Saint Petersburg, , Russia
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Seoul National University Hospital
Seoul, , South Korea
National Taiwan University Hospital
Taipei, , Taiwan
Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Guy's Hospital
London, , United Kingdom
Countries
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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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2020-000189-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1368-0024
Identifier Type: -
Identifier Source: org_study_id
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