Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study

Background CT-P43 is a candidate ustekinumab biosimilar in clinical development. Objectives This paper aims to demonstrate equivalent efficacy of CT-P43 to originator ustekinumab in adults with moderate to severe plaque psoriasis. Methods This double-blind, phase III trial randomised patients (1:1)...

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Veröffentlicht in:	BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy biopharmaceuticals, and gene therapy, 2024-01, Vol.38 (1), p.121-131
Hauptverfasser:	Papp, Kim A., Lebwohl, Mark G., Thaçi, Diamant, Jaworski, Janusz, Kwiek, Bartlomiej, Trefler, Jakub, Dudek, Anna, Szepietowski, Jacek C., Reznichenko, Nataliya, Narbutt, Joanna, Baran, Wojciech, Kolinek, Joanna, Daniluk, Stefan, Bartnicka-Maslowska, Katarzyna, Reich, Adam, Andrashko, Yuriy, Kim, Sunghyun, Bae, Yunju, Jeon, Dabee, Jung, Jinsun, Lee, Hyunseung, Pyo, Tina, Ko, Woori
Format:	Artikel
Sprache:	eng
Schlagworte:	Antibodies Biological products Biomedical and Life Sciences Biomedicine Body weight Cancer Research Clinical trials Drug dosages FDA approval Immunogenicity Molecular Medicine Monoclonal antibodies NCT NCT04673786 Original Original Research Article Patients Pharmacokinetics Pharmacotherapy Psoriasis Regulatory approval Safety Statistical power
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