Kim A Papp, Mark G Lebwohl, Diamant Thaçi, Janusz Jaworski, Bartlomiej Kwiek, Jakub Trefler, Anna Dudek, Jacek C Szepietowski, Nataliya Reznichenko, Joanna Narbutt, Wojciech Baran, Joanna Kolinek, Stefan Daniluk, Katarzyna Bartnicka-Maslowska, Adam Reich, Yuriy Andrashko, Sunghyun Kim, Yunju Bae, Dabee Jeon, Jinsun Jung, Hyunseung Lee, Tina Pyo, Woori Ko
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) to receive subcutaneous CT-P43 or originator ustekinumab (45/90 mg for patients with baseline body weight ≤ 100 kg/> 100 kg) at week 0 and week 4 in Treatment Period I...
November 22, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy