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
IntroductionGeneralized pustular psoriasis (GPP) is a rare, potentially life-threatening disease characterised by recurrent flares of widespread neutrophilic aseptic skin pustular eruption. Despite the availability of approved biologics for GPP in Japan, Taiwan and Thailand, associated evidence is l...
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| Published in | BMJ open Vol. 11; no. 3; p. e043666 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
British Medical Journal Publishing Group
30.03.2021
BMJ Publishing Group LTD BMJ Publishing Group |
| Series | Protocol |
| Subjects | |
| Online Access | Get full text |
| ISSN | 2044-6055 2044-6055 |
| DOI | 10.1136/bmjopen-2020-043666 |
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| Abstract | IntroductionGeneralized pustular psoriasis (GPP) is a rare, potentially life-threatening disease characterised by recurrent flares of widespread neutrophilic aseptic skin pustular eruption. Despite the availability of approved biologics for GPP in Japan, Taiwan and Thailand, associated evidence is largely based on uncontrolled studies in which acute flares were not directly assessed. Therefore, there is a high unmet need to investigate new rapid-acting effective treatments that resolve symptoms associated with acute GPP flares. A prior Phase I proof-of-concept study showed rapid improvements in skin and pustule clearance with a single intravenous dose of spesolimab, a novel anti-interleukin-36 receptor antibody, in patients presenting with an acute GPP flare. Here, we present the design and rationale of Effisayil 1, a global, Phase II, placebo-controlled study to evaluate the efficacy, safety and tolerability of spesolimab in patients presenting with an acute GPP flare.Methods and analysisAt least 51 patients with an acute GPP flare will be randomised 2:1 to receive a single 900 mg intravenous dose of spesolimab or placebo and followed for up to 28 weeks. The primary endpoint is a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (pustule clearance) at Week 1. The key secondary endpoint is a GPPGA score of 0 or 1 (clear or almost clear) at Week 1. Safety will be assessed over the study duration by the occurrence of treatment-emergent adverse events. Blood and skin biopsies will be collected to assess biomarkers. Superiority of spesolimab over placebo in the proportion of patients achieving the primary and key secondary endpoints will be evaluated.Ethics and disseminationThe study complies with the ethical principles of the Declaration of Helsinki, the International Council for Harmonisation’s Good Clinical Practice and local regulations. Ethics committee approvals have been obtained for each centre from all participating countries and are listed in online supplementary file 1. Primary results will be published in a peer-reviewed journal.Trial registration detailsClinicalTrials.gov identifier: NCT03782792; Pre-results. |
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| AbstractList | IntroductionGeneralized pustular psoriasis (GPP) is a rare, potentially life-threatening disease characterised by recurrent flares of widespread neutrophilic aseptic skin pustular eruption. Despite the availability of approved biologics for GPP in Japan, Taiwan and Thailand, associated evidence is largely based on uncontrolled studies in which acute flares were not directly assessed. Therefore, there is a high unmet need to investigate new rapid-acting effective treatments that resolve symptoms associated with acute GPP flares. A prior Phase I proof-of-concept study showed rapid improvements in skin and pustule clearance with a single intravenous dose of spesolimab, a novel anti-interleukin-36 receptor antibody, in patients presenting with an acute GPP flare. Here, we present the design and rationale of Effisayil 1, a global, Phase II, placebo-controlled study to evaluate the efficacy, safety and tolerability of spesolimab in patients presenting with an acute GPP flare.Methods and analysisAt least 51 patients with an acute GPP flare will be randomised 2:1 to receive a single 900 mg intravenous dose of spesolimab or placebo and followed for up to 28 weeks. The primary endpoint is a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (pustule clearance) at Week 1. The key secondary endpoint is a GPPGA score of 0 or 1 (clear or almost clear) at Week 1. Safety will be assessed over the study duration by the occurrence of treatment-emergent adverse events. Blood and skin biopsies will be collected to assess biomarkers. Superiority of spesolimab over placebo in the proportion of patients achieving the primary and key secondary endpoints will be evaluated.Ethics and disseminationThe study complies with the ethical principles of the Declaration of Helsinki, the International Council for Harmonisation’s Good Clinical Practice and local regulations. Ethics committee approvals have been obtained for each centre from all participating countries and are listed in online supplementary file 1. Primary results will be published in a peer-reviewed journal.Trial registration detailsClinicalTrials.gov identifier: NCT03782792; Pre-results. Generalized pustular psoriasis (GPP) is a rare, potentially life-threatening disease characterised by recurrent flares of widespread neutrophilic aseptic skin pustular eruption. Despite the availability of approved biologics for GPP in Japan, Taiwan and Thailand, associated evidence is largely based on uncontrolled studies in which acute flares were not directly assessed. Therefore, there is a high unmet need to investigate new rapid-acting effective treatments that resolve symptoms associated with acute GPP flares. A prior Phase I proof-of-concept study showed rapid improvements in skin and pustule clearance with a single intravenous dose of spesolimab, a novel anti-interleukin-36 receptor antibody, in patients presenting with an acute GPP flare. Here, we present the design and rationale of Effisayil 1, a global, Phase II, placebo-controlled study to evaluate the efficacy, safety and tolerability of spesolimab in patients presenting with an acute GPP flare.INTRODUCTIONGeneralized pustular psoriasis (GPP) is a rare, potentially life-threatening disease characterised by recurrent flares of widespread neutrophilic aseptic skin pustular eruption. Despite the availability of approved biologics for GPP in Japan, Taiwan and Thailand, associated evidence is largely based on uncontrolled studies in which acute flares were not directly assessed. Therefore, there is a high unmet need to investigate new rapid-acting effective treatments that resolve symptoms associated with acute GPP flares. A prior Phase I proof-of-concept study showed rapid improvements in skin and pustule clearance with a single intravenous dose of spesolimab, a novel anti-interleukin-36 receptor antibody, in patients presenting with an acute GPP flare. Here, we present the design and rationale of Effisayil 1, a global, Phase II, placebo-controlled study to evaluate the efficacy, safety and tolerability of spesolimab in patients presenting with an acute GPP flare.At least 51 patients with an acute GPP flare will be randomised 2:1 to receive a single 900 mg intravenous dose of spesolimab or placebo and followed for up to 28 weeks. The primary endpoint is a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (pustule clearance) at Week 1. The key secondary endpoint is a GPPGA score of 0 or 1 (clear or almost clear) at Week 1. Safety will be assessed over the study duration by the occurrence of treatment-emergent adverse events. Blood and skin biopsies will be collected to assess biomarkers. Superiority of spesolimab over placebo in the proportion of patients achieving the primary and key secondary endpoints will be evaluated.METHODS AND ANALYSISAt least 51 patients with an acute GPP flare will be randomised 2:1 to receive a single 900 mg intravenous dose of spesolimab or placebo and followed for up to 28 weeks. The primary endpoint is a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (pustule clearance) at Week 1. The key secondary endpoint is a GPPGA score of 0 or 1 (clear or almost clear) at Week 1. Safety will be assessed over the study duration by the occurrence of treatment-emergent adverse events. Blood and skin biopsies will be collected to assess biomarkers. Superiority of spesolimab over placebo in the proportion of patients achieving the primary and key secondary endpoints will be evaluated.The study complies with the ethical principles of the Declaration of Helsinki, the International Council for Harmonisation's Good Clinical Practice and local regulations. Ethics committee approvals have been obtained for each centre from all participating countries and are listed in online supplementary file 1. Primary results will be published in a peer-reviewed journal.ETHICS AND DISSEMINATIONThe study complies with the ethical principles of the Declaration of Helsinki, the International Council for Harmonisation's Good Clinical Practice and local regulations. Ethics committee approvals have been obtained for each centre from all participating countries and are listed in online supplementary file 1. Primary results will be published in a peer-reviewed journal.ClinicalTrials.gov identifier: NCT03782792; Pre-results.TRIAL REGISTRATION DETAILSClinicalTrials.gov identifier: NCT03782792; Pre-results. Generalized pustular psoriasis (GPP) is a rare, potentially life-threatening disease characterised by recurrent flares of widespread neutrophilic aseptic skin pustular eruption. Despite the availability of approved biologics for GPP in Japan, Taiwan and Thailand, associated evidence is largely based on uncontrolled studies in which acute flares were not directly assessed. Therefore, there is a high unmet need to investigate new rapid-acting effective treatments that resolve symptoms associated with acute GPP flares. A prior Phase I proof-of-concept study showed rapid improvements in skin and pustule clearance with a single intravenous dose of spesolimab, a novel anti-interleukin-36 receptor antibody, in patients presenting with an acute GPP flare. Here, we present the design and rationale of Effisayil 1, a global, Phase II, placebo-controlled study to evaluate the efficacy, safety and tolerability of spesolimab in patients presenting with an acute GPP flare. At least 51 patients with an acute GPP flare will be randomised 2:1 to receive a single 900 mg intravenous dose of spesolimab or placebo and followed for up to 28 weeks. The primary endpoint is a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (pustule clearance) at Week 1. The key secondary endpoint is a GPPGA score of 0 or 1 (clear or almost clear) at Week 1. Safety will be assessed over the study duration by the occurrence of treatment-emergent adverse events. Blood and skin biopsies will be collected to assess biomarkers. Superiority of spesolimab over placebo in the proportion of patients achieving the primary and key secondary endpoints will be evaluated. The study complies with the ethical principles of the Declaration of Helsinki, the International Council for Harmonisation's Good Clinical Practice and local regulations. Ethics committee approvals have been obtained for each centre from all participating countries and are listed in online supplementary file 1. Primary results will be published in a peer-reviewed journal. ClinicalTrials.gov identifier: NCT03782792; Pre-results. Introduction Generalized pustular psoriasis (GPP) is a rare, potentially life-threatening disease characterised by recurrent flares of widespread neutrophilic aseptic skin pustular eruption. Despite the availability of approved biologics for GPP in Japan, Taiwan and Thailand, associated evidence is largely based on uncontrolled studies in which acute flares were not directly assessed. Therefore, there is a high unmet need to investigate new rapid-acting effective treatments that resolve symptoms associated with acute GPP flares. A prior Phase I proof-of-concept study showed rapid improvements in skin and pustule clearance with a single intravenous dose of spesolimab, a novel anti-interleukin-36 receptor antibody, in patients presenting with an acute GPP flare. Here, we present the design and rationale of Effisayil 1, a global, Phase II, placebo-controlled study to evaluate the efficacy, safety and tolerability of spesolimab in patients presenting with an acute GPP flare.Methods and analysis At least 51 patients with an acute GPP flare will be randomised 2:1 to receive a single 900 mg intravenous dose of spesolimab or placebo and followed for up to 28 weeks. The primary endpoint is a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (pustule clearance) at Week 1. The key secondary endpoint is a GPPGA score of 0 or 1 (clear or almost clear) at Week 1. Safety will be assessed over the study duration by the occurrence of treatment-emergent adverse events. Blood and skin biopsies will be collected to assess biomarkers. Superiority of spesolimab over placebo in the proportion of patients achieving the primary and key secondary endpoints will be evaluated.Ethics and dissemination The study complies with the ethical principles of the Declaration of Helsinki, the International Council for Harmonisation’s Good Clinical Practice and local regulations. Ethics committee approvals have been obtained for each centre from all participating countries and are listed in online supplementary file 1. Primary results will be published in a peer-reviewed journal.Trial registration details ClinicalTrials.gov identifier: NCT03782792; Pre-results. |
| Author | Lebwohl, Mark G Navarini, Alexander A Tetzlaff, Kay Burden, A David Zheng, Min Marrakchi, Slaheddine Xu, Jinhua Thoma, Christian Choon, Siew Eng Rajeswari, Sushmita Turki, Hamida Morita, Akimichi Bachelez, Hervé Tsai, Tsen-Fang Deng, Hongjie |
| AuthorAffiliation | 4 Institute of Infection, Immunity and Inflammation, University of Glasgow , Glasgow , UK 6 Department of Geriatric and Environmental Dermatology, Nagoya City University, Graduate School of Medical Sciences , Nagoya , Japan 1 Jeffrey Cheah School of Medicine and Health Sciences, Clinical School Johor Bahru, Monash University Malaysia , Johor Bahru , Johor , Malaysia 13 Boehringer Ingelheim International GmbH , Biberach , Germany 7 Department of Dermatology, University Hospital Basel , Basel , Switzerland 2 Icahn School of Medicine at Mount Sinai , New York , New York , USA 12 Boehringer Ingelheim International GmbH , Ingelheim , Germany 8 Department of Dermatology, Second Affiliated Hospital, Zhejiang University, School of Medicine , Hangzhou , China 9 Department of Dermatology, Huashan Hospital, Fudan University , Shanghai , China 14 Service de Dermatologie, Assistance Publique-Hôpitaux de Paris Hôpital Saint-Louis , Paris , France 3 Dermatology Department, Hedi Chaker University Hospital , Sfa |
| AuthorAffiliation_xml | – name: 2 Icahn School of Medicine at Mount Sinai , New York , New York , USA – name: 1 Jeffrey Cheah School of Medicine and Health Sciences, Clinical School Johor Bahru, Monash University Malaysia , Johor Bahru , Johor , Malaysia – name: 11 Boehringer Ingelheim (China), Investment Co Ltd , Shanghai , China – name: 9 Department of Dermatology, Huashan Hospital, Fudan University , Shanghai , China – name: 6 Department of Geriatric and Environmental Dermatology, Nagoya City University, Graduate School of Medical Sciences , Nagoya , Japan – name: 14 Service de Dermatologie, Assistance Publique-Hôpitaux de Paris Hôpital Saint-Louis , Paris , France – name: 15 INSERM U1163, Imagine Institute for Genetics of Human Diseases, Université de Paris , Paris , France – name: 13 Boehringer Ingelheim International GmbH , Biberach , Germany – name: 8 Department of Dermatology, Second Affiliated Hospital, Zhejiang University, School of Medicine , Hangzhou , China – name: 5 Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine , Taipei , Taiwan – name: 12 Boehringer Ingelheim International GmbH , Ingelheim , Germany – name: 7 Department of Dermatology, University Hospital Basel , Basel , Switzerland – name: 10 Boehringer Ingelheim Pharmaceuticals , Ridgefield , Connecticut , USA – name: 3 Dermatology Department, Hedi Chaker University Hospital , Sfax , Tunisia – name: 4 Institute of Infection, Immunity and Inflammation, University of Glasgow , Glasgow , UK |
| Author_xml | – sequence: 1 givenname: Siew Eng surname: Choon fullname: Choon, Siew Eng organization: Jeffrey Cheah School of Medicine and Health Sciences, Clinical School Johor Bahru, Monash University Malaysia, Johor Bahru, Johor, Malaysia – sequence: 2 givenname: Mark G surname: Lebwohl fullname: Lebwohl, Mark G organization: Icahn School of Medicine at Mount Sinai, New York, New York, USA – sequence: 3 givenname: Slaheddine surname: Marrakchi fullname: Marrakchi, Slaheddine organization: Dermatology Department, Hedi Chaker University Hospital, Sfax, Tunisia – sequence: 4 givenname: A David surname: Burden fullname: Burden, A David organization: Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK – sequence: 5 givenname: Tsen-Fang surname: Tsai fullname: Tsai, Tsen-Fang organization: Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan – sequence: 6 givenname: Akimichi surname: Morita fullname: Morita, Akimichi organization: Department of Geriatric and Environmental Dermatology, Nagoya City University, Graduate School of Medical Sciences, Nagoya, Japan – sequence: 7 givenname: Alexander A surname: Navarini fullname: Navarini, Alexander A organization: Department of Dermatology, University Hospital Basel, Basel, Switzerland – sequence: 8 givenname: Min surname: Zheng fullname: Zheng, Min organization: Department of Dermatology, Second Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou, China – sequence: 9 givenname: Jinhua surname: Xu fullname: Xu, Jinhua organization: Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China – sequence: 10 givenname: Hamida surname: Turki fullname: Turki, Hamida organization: Dermatology Department, Hedi Chaker University Hospital, Sfax, Tunisia – sequence: 11 givenname: Sushmita surname: Rajeswari fullname: Rajeswari, Sushmita organization: Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut, USA – sequence: 12 givenname: Hongjie surname: Deng fullname: Deng, Hongjie organization: Boehringer Ingelheim (China), Investment Co Ltd, Shanghai, China – sequence: 13 givenname: Kay surname: Tetzlaff fullname: Tetzlaff, Kay organization: Boehringer Ingelheim International GmbH, Ingelheim, Germany – sequence: 14 givenname: Christian surname: Thoma fullname: Thoma, Christian organization: Boehringer Ingelheim International GmbH, Biberach, Germany – sequence: 15 givenname: Hervé surname: Bachelez fullname: Bachelez, Hervé email: herve.bachelez@aphp.fr organization: INSERM U1163, Imagine Institute for Genetics of Human Diseases, Université de Paris, Paris, France |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33785490$$D View this record in MEDLINE/PubMed |
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| DOI | 10.1136/bmjopen-2020-043666 |
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| Keywords | dermatopathology psoriasis clinical trials |
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| Snippet | IntroductionGeneralized pustular psoriasis (GPP) is a rare, potentially life-threatening disease characterised by recurrent flares of widespread neutrophilic... Generalized pustular psoriasis (GPP) is a rare, potentially life-threatening disease characterised by recurrent flares of widespread neutrophilic aseptic skin... Introduction Generalized pustular psoriasis (GPP) is a rare, potentially life-threatening disease characterised by recurrent flares of widespread neutrophilic... |
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| SubjectTerms | clinical trials Cytokines Dermatology dermatopathology Disease Double-blind studies Erythema Inflammation Monoclonal antibodies Mutation Psoriasis TNF inhibitors Tumor necrosis factor-TNF |
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| Title | 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 |
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