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Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials.

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Title: Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials.
Authors: Maurer M; Urticaria Center of Reference and Excellence (UCARE), Institute of Allergology, Charité-Universitätsmedizin Berlin, Germany; Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany. Electronic address: marcus.maurer@charite.de., Ensina LF; Federal University of São Paulo, São Paulo, Brazil; CPAlpha Clinical Research Center, Barueri, Brazil., Gimenez-Arnau AM; Department of Dermatology, Hospital del Mar-IMIM, Universitat Pompeu Fabra, Barcelona, Spain., Sussman G; Division of Allergy and Clinical Immunology, University of Toronto, Canada., Hide M; Department of Dermatology, Hiroshima University, Hiroshima, Japan; Department of Dermatology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan., Saini S; Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, MD, USA., Grattan C; St John's Institute of Dermatology, Guy's and St Thomas' Hospitals NHS Foundation Trust, London, UK., Fomina D; Center of Allergy and Immunology, Clinical State Hospital 52, Moscow Ministry of Healthcare, Moscow, Russia; Department of Clinical Allergology and Immunology, I M Sechenov First Moscow State Medical University, Moscow, Russia., Rigopoulos D; A Sygros University Hospital of Venereal and Skin Diseases, Athens, Greece., Berard F; Département d'Allergologie et Immunologie Clinique, CHU Lyon-Sud, Pierre Bénite Cedex, France., Canonica GW; Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center, IRCCS, Rozzano, Milan, Italy; Department of Biomedical Science, Humanitas University-Pieve Emanuele, Milan, Italy., Rockmann H; Department of Dermatology and Allergology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands., Irani C; Internal Medicine and Clinical Immunology, Saint Joseph University, Beirut, Lebanon., Szepietowski JC; Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland., Leflein J; Allergy and Immunology Associates of Ann Arbor, PC Ann Arbor, Michigan, MI, USA., Bernstein JA; University of Cincinnati College of Medicine Division of Rheumatology, Allergy, and Immunology and Bernstein Clinical Research Center, Cincinnati, OH, USA., Peter JG; Division of Allergology and Clinical Immunology, Department of Medicine, University of Cape Town, Cape Town, South Africa; Allergy and Immunology Unit, University of Cape Town Lung Institute, Cape Town, South Africa., Kulthanan K; Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand., Godse K; Department of Dermatology, D Y Patil School of Medicine, Navi Mumbai, Maharashtra, India., Ardusso L; Department of Pulmonology, Allergy and Immunology, School of Medicine, National University of Rosario, Rosario, Santa Fe, Argentina., Ukhanova O; Scientific Medical Center of General Therapy and Pharmacology, Stavropol, Russia., Staubach P; Department of Dermatology, University Medical Center, Mainz, Germany., Sinclair R; Department of Dermatology, St Vincent's Hospital, The Skin and Cancer Foundation of Victoria and The University of Melbourne, Victoria, VIC, Australia., Gogate S; Colorado Allergy and Asthma Centers, Denver, Colorado, CO, USA., Thomsen SF; Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Biomedical Sciences, Copenhagen, Denmark., Tanus T; Kern Allergy Medical Clinic, Bakersfield, CA, USA., Ye YM; Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, South Korea., Burciu A; Novartis Pharma, Basel, Switzerland., Barve A; Novartis Pharmaceuticals, East Hanover, New Jersey, NJ, USA., Modi D; Novartis Pharmaceuticals, East Hanover, New Jersey, NJ, USA., Scosyrev E; Novartis Pharmaceuticals, East Hanover, New Jersey, NJ, USA., Hua E; China Novartis Institutes for Biomedical Research, Shanghai, China., Letzelter K; Novartis Pharma, Basel, Switzerland., Varanasi V; Novartis Healthcare Private, Hyderabad, India., Patekar M; Novartis Pharma, Basel, Switzerland., Severin T; Novartis Pharma, Basel, Switzerland.
Corporate Authors: PEARL-1 and PEARL-2 trial investigators
Source: Lancet (London, England) [Lancet] 2024 Jan 13; Vol. 403 (10422), pp. 147-159. Date of Electronic Publication: 2023 Nov 23.
Publication Type: Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Journal Info: Publisher: Elsevier Country of Publication: England NLM ID: 2985213R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1474-547X (Electronic) Linking ISSN: 01406736 NLM ISO Abbreviation: Lancet Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials.
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  Data: <searchLink fieldCode="AU" term="%22Maurer+M%22">Maurer M</searchLink>; Urticaria Center of Reference and Excellence (UCARE), Institute of Allergology, Charité-Universitätsmedizin Berlin, Germany; Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany. Electronic address: marcus.maurer@charite.de.<br /><searchLink fieldCode="AU" term="%22Ensina+LF%22">Ensina LF</searchLink>; Federal University of São Paulo, São Paulo, Brazil; CPAlpha Clinical Research Center, Barueri, Brazil.<br /><searchLink fieldCode="AU" term="%22Gimenez-Arnau+AM%22">Gimenez-Arnau AM</searchLink>; Department of Dermatology, Hospital del Mar-IMIM, Universitat Pompeu Fabra, Barcelona, Spain.<br /><searchLink fieldCode="AU" term="%22Sussman+G%22">Sussman G</searchLink>; Division of Allergy and Clinical Immunology, University of Toronto, Canada.<br /><searchLink fieldCode="AU" term="%22Hide+M%22">Hide M</searchLink>; Department of Dermatology, Hiroshima University, Hiroshima, Japan; Department of Dermatology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.<br /><searchLink fieldCode="AU" term="%22Saini+S%22">Saini S</searchLink>; Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, MD, USA.<br /><searchLink fieldCode="AU" term="%22Grattan+C%22">Grattan C</searchLink>; St John's Institute of Dermatology, Guy's and St Thomas' Hospitals NHS Foundation Trust, London, UK.<br /><searchLink fieldCode="AU" term="%22Fomina+D%22">Fomina D</searchLink>; Center of Allergy and Immunology, Clinical State Hospital 52, Moscow Ministry of Healthcare, Moscow, Russia; Department of Clinical Allergology and Immunology, I M Sechenov First Moscow State Medical University, Moscow, Russia.<br /><searchLink fieldCode="AU" term="%22Rigopoulos+D%22">Rigopoulos D</searchLink>; A Sygros University Hospital of Venereal and Skin Diseases, Athens, Greece.<br /><searchLink fieldCode="AU" term="%22Berard+F%22">Berard F</searchLink>; Département d'Allergologie et Immunologie Clinique, CHU Lyon-Sud, Pierre Bénite Cedex, France.<br /><searchLink fieldCode="AU" term="%22Canonica+GW%22">Canonica GW</searchLink>; Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center, IRCCS, Rozzano, Milan, Italy; Department of Biomedical Science, Humanitas University-Pieve Emanuele, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Rockmann+H%22">Rockmann H</searchLink>; Department of Dermatology and Allergology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.<br /><searchLink fieldCode="AU" term="%22Irani+C%22">Irani C</searchLink>; Internal Medicine and Clinical Immunology, Saint Joseph University, Beirut, Lebanon.<br /><searchLink fieldCode="AU" term="%22Szepietowski+JC%22">Szepietowski JC</searchLink>; Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland.<br /><searchLink fieldCode="AU" term="%22Leflein+J%22">Leflein J</searchLink>; Allergy and Immunology Associates of Ann Arbor, PC Ann Arbor, Michigan, MI, USA.<br /><searchLink fieldCode="AU" term="%22Bernstein+JA%22">Bernstein JA</searchLink>; University of Cincinnati College of Medicine Division of Rheumatology, Allergy, and Immunology and Bernstein Clinical Research Center, Cincinnati, OH, USA.<br /><searchLink fieldCode="AU" term="%22Peter+JG%22">Peter JG</searchLink>; Division of Allergology and Clinical Immunology, Department of Medicine, University of Cape Town, Cape Town, South Africa; Allergy and Immunology Unit, University of Cape Town Lung Institute, Cape Town, South Africa.<br /><searchLink fieldCode="AU" term="%22Kulthanan+K%22">Kulthanan K</searchLink>; Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.<br /><searchLink fieldCode="AU" term="%22Godse+K%22">Godse K</searchLink>; Department of Dermatology, D Y Patil School of Medicine, Navi Mumbai, Maharashtra, India.<br /><searchLink fieldCode="AU" term="%22Ardusso+L%22">Ardusso L</searchLink>; Department of Pulmonology, Allergy and Immunology, School of Medicine, National University of Rosario, Rosario, Santa Fe, Argentina.<br /><searchLink fieldCode="AU" term="%22Ukhanova+O%22">Ukhanova O</searchLink>; Scientific Medical Center of General Therapy and Pharmacology, Stavropol, Russia.<br /><searchLink fieldCode="AU" term="%22Staubach+P%22">Staubach P</searchLink>; Department of Dermatology, University Medical Center, Mainz, Germany.<br /><searchLink fieldCode="AU" term="%22Sinclair+R%22">Sinclair R</searchLink>; Department of Dermatology, St Vincent's Hospital, The Skin and Cancer Foundation of Victoria and The University of Melbourne, Victoria, VIC, Australia.<br /><searchLink fieldCode="AU" term="%22Gogate+S%22">Gogate S</searchLink>; Colorado Allergy and Asthma Centers, Denver, Colorado, CO, USA.<br /><searchLink fieldCode="AU" term="%22Thomsen+SF%22">Thomsen SF</searchLink>; Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Biomedical Sciences, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Tanus+T%22">Tanus T</searchLink>; Kern Allergy Medical Clinic, Bakersfield, CA, USA.<br /><searchLink fieldCode="AU" term="%22Ye+YM%22">Ye YM</searchLink>; Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, South Korea.<br /><searchLink fieldCode="AU" term="%22Burciu+A%22">Burciu A</searchLink>; Novartis Pharma, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Barve+A%22">Barve A</searchLink>; Novartis Pharmaceuticals, East Hanover, New Jersey, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Modi+D%22">Modi D</searchLink>; Novartis Pharmaceuticals, East Hanover, New Jersey, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Scosyrev+E%22">Scosyrev E</searchLink>; Novartis Pharmaceuticals, East Hanover, New Jersey, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Hua+E%22">Hua E</searchLink>; China Novartis Institutes for Biomedical Research, Shanghai, China.<br /><searchLink fieldCode="AU" term="%22Letzelter+K%22">Letzelter K</searchLink>; Novartis Pharma, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Varanasi+V%22">Varanasi V</searchLink>; Novartis Healthcare Private, Hyderabad, India.<br /><searchLink fieldCode="AU" term="%22Patekar+M%22">Patekar M</searchLink>; Novartis Pharma, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Severin+T%22">Severin T</searchLink>; Novartis Pharma, Basel, Switzerland.
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  Data: <searchLink fieldCode="JN" term="%222985213R%22">Lancet (London, England)</searchLink> [Lancet] 2024 Jan 13; Vol. 403 (10422), pp. 147-159. <i>Date of Electronic Publication: </i>2023 Nov 23.
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  Data: Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
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