PSORITUS - Secukinumab study in PSOriasis exploring pruRITUS intensity and lesional biomarkers (CAIN457ADE03). Homo sapiens

Exploratory study on the kinetics of psoriasis symptoms, pruritus intensity and lesional biomarkers in patients with moderate to severe plaque-type psoriasis treated with subcutaneous secukinumab (300 mg) during a 16 week open-label run-in phase followed by a 16 week randomized, double-blind, placebo-controlled withdrawal phase. Overall design: Psoriasis patients received 300 mg subcutaneous secukinumab during a 16 week open-label run-in phase followed by 16 week randomized, double-blind, placebo-controlled withdrawal phase

本研究为一项探索性研究，旨在探究接受皮下注射司库奇尤单抗（secukinumab，300 mg）治疗的中重度斑块型银屑病（plaque-type psoriasis）患者的银屑病症状、瘙痒强度及皮损生物标志物（lesional biomarkers）的动力学变化；所有受试者均先经历16周开放标签导入期（open-label run-in phase），随后进入16周随机双盲安慰剂对照停药期（randomized, double-blind, placebo-controlled withdrawal phase）。整体设计：银屑病患者在16周开放标签导入期内接受300 mg皮下注射司库奇尤单抗治疗，随后进入16周随机双盲安慰剂对照停药期。