[Translation] A Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of UB-221 as add-on therapy in patients with chronic spontaneous urticaria (CSU)
主要目的:评估 CSU 患者中各种 UB-221SC 剂量与安慰剂相比的疗效。次要目的:评估 CSU 患者中不同剂量队列的疗效;评估研究药物首次给药后至完全缓解(UAS7=0)、UAS7≤6和首次复发时间方面的疗效;评估UB-221 SC 对于首次给药后至首次使用补救药物时间、补救药物使用天数和每周使用补救药物的片剂数量方面的疗效;评估 CSU 患者中不同剂量队列的安全性和耐受性;CSU 患者中 UB-221 SC 的药代动力学(PK);CSU 患者中不同剂量队列的药效学(PD);CSU 患者中不同剂量队列的免疫原性;评估 CSU 患者不同剂量组的皮肤病生活质量指数(DLQI)。探索性目的:探索 UB-221 SC 在 CSU 患者中的作用机制。
[Translation] Primary Objective: To evaluate the efficacy of various UB-221SC doses compared to placebo in CSU patients. Secondary Objectives: To evaluate the efficacy of different dose cohorts in CSU patients; To evaluate the efficacy of the study drug in terms of time to complete remission (UAS7=0), UAS7≤6, and first relapse after the first dose; To evaluate the efficacy of UB-221 SC in terms of time to first rescue medication use after the first dose, number of rescue medication use days, and number of rescue medication tablets per week; To evaluate the safety and tolerability of different dose cohorts in CSU patients; Pharmacokinetics (PK) of UB-221 SC in CSU patients; Pharmacodynamics (PD) of different dose cohorts in CSU patients; Immunogenicity of different dose cohorts in CSU patients; To evaluate the Dermatology Life Quality Index (DLQI) of different dose groups in CSU patients. Exploratory Objectives: To explore the mechanism of action of UB-221 SC in CSU patients.