Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis
NCT ID: NCT03782792
Last Updated: 2025-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
53 participants
INTERVENTIONAL
2019-01-31
2021-01-05
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
Spesolimab
Solution for infusion
Placebo
Placebo
Solution for infusion
Interventions
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Spesolimab
Solution for infusion
Placebo
Solution for infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\-- Patients with an acute flare of moderate to severe intensity meeting the (ERASPEN) criteria of GPP with a known and documented history of GPP (per ERASPEN criteria) regardless of IL36RN mutation status, with previous evidence of fever, and/or asthenia, and/or myalgia, and/or elevated C-reactive protein, and/or leucocytosis with peripheral blood neutrophilia (above ULN)
* Male or female patients, aged 18 to 75 years at screening.
* Signed and dated written informed consent prior to admission to the study in accordance with ICH GCP and local legislation prior to start of any screening procedures.
* 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. Note: A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is not a method of permanent sterilization. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause
Exclusion Criteria
* Patients with primary erythrodermic psoriasis vulgaris.
* Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques.
* Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP).
* Immediate life-threatening flare of GPP or requiring intensive care treatment, according to the investigator's judgement. Life-threatening complications mainly include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary distress syndrome, or renal failure.
* Severe, progressive, or uncontrolled hepatic disease, defined as \>3- fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or \>2-fold ULN elevation in total bilirubin.
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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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Miami
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
The First Hospital of Dalian Medical University
Dalian, , China
2nd Affiliated Hosp Zhejiang University College of Medical
Hangzhou, , China
Shanghai Skin Disease Hospital
Shanghai, , China
Huashan Hospital, Fudan University
Shanghai, , China
Tianjin Medical University General Hospital
Tianjin, , China
HOP Saint-André
Bordeaux, , France
HOP Saint-Louis
Paris, , France
HOP Robert Debré
Reims, , France
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Bonn AöR
Bonn, , Germany
Universitätsklinikum Essen AöR
Essen, , Germany
Klinikum der Universität München - Campus Innenstadt
München, , Germany
Nagoya City University Hospital
Aichi, Nagoya, , Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, , Japan
Asahikawa Medical University Hospital
Hokkaido, Asahikawa, , Japan
Tohoku University Hospital
Miyagi, Sendai, , Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, Hachioji, , Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, , Japan
Hospital Sultanah Aminah
Johor Bahru, , Malaysia
Hospital Sultan Ismail
Johor Bahru, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
Hospital Selayang
Kuala Selangor, , Malaysia
Hospital Pakar Sultanah Fatimah
Muar town, , Malaysia
Hospital Raja Permaisuri Bainun
Negeri Perak/Ipoh, , Malaysia
Hospital Pulau Pinang
Pulau Pinang, , Malaysia
National University Hospital
Singapore, , Singapore
Severance Hospital
Seoul, , South Korea
University Hospital of Lausanne
Lausanne, , Switzerland
National Taiwan University Hospital
Taipei, , Taiwan
Ramathibodi Hospital
Ratchatewi, Bangkok, , Thailand
Farhat Hached Hospital
Sousse, , Tunisia
La Rabta Hospital
Tunis, , Tunisia
Hedi Chaker Hospital, Department of Dermatology
Tunisia, , Tunisia
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.
Gwillim EC, Nichols AJ. Spesolimab for generalized pustular psoriasis: a review of two key clinical trials supporting initial US regulatory approval. Front Immunol. 2024 Jul 22;15:1359481. doi: 10.3389/fimmu.2024.1359481. eCollection 2024.
Tsai TF, Zheng M, Ding Y, Song Z, Liu Q, Chen Y, Hu H, Xu J. Efficacy and Safety of Spesolimab in Patients with Generalized Pustular Psoriasis: A Subgroup Analysis of Chinese Patients in the Effisayil 1 Trial. Dermatol Ther (Heidelb). 2023 Dec;13(12):3097-3110. doi: 10.1007/s13555-023-01037-4. Epub 2023 Oct 16.
Bachelez H, Choon SE, Marrakchi S, Burden AD, Tsai TF, Morita A, Navarini AA, Zheng M, Xu J, Turki H, Anadkat MJ, Rajeswari S, Hua H, Vulcu SD, Hall D, Tetzlaff K, Thoma C, Lebwohl MG; Effisayil 1 Trial Investigators. Trial of Spesolimab for Generalized Pustular Psoriasis. N Engl J Med. 2021 Dec 23;385(26):2431-2440. doi: 10.1056/NEJMoa2111563.
Choon SE, Lebwohl MG, Marrakchi S, Burden AD, Tsai TF, Morita A, Navarini AA, Zheng M, Xu J, Turki H, Rajeswari S, Deng H, Tetzlaff K, Thoma C, Bachelez H. Study protocol of the global Effisayil 1 Phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. BMJ Open. 2021 Mar 30;11(3):e043666. doi: 10.1136/bmjopen-2020-043666.
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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2017-004231-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1368-0013
Identifier Type: -
Identifier Source: org_study_id
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