[Translation] A Phase IIb, randomized, double-blind, parallel study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of subcutaneous (SC) injection of GSK1070806 in adult subjects with moderate to severe atopic dermatitis (AtD) group, placebo-controlled, dose-finding study.
主要目的:评价GSK1070806 200 MG与安慰剂相比在中度至重度ATD成人中的疗效。
次要目的:通过表征中度至重度ATD成人的纵向剂量-反应关系,评价剂量范围内GSK1070806与安慰剂相比的疗效; 进一步评价GSK1070806 200 MG和整个剂量范围与安慰剂相比在中度至重度ATD成人中的影响; 进一步评价GSK1070806 200 MG和整个剂量范围与安慰剂相比在中度至重度ATD成人中的疗效; 在中度至重度ATD成人中评估GSK1070806 200 MG和整个剂量范围与安慰剂相比对通过一系列患者报告结局PRO测量的健康相关生活质量(HR-QOL)、抑郁和焦虑、疲劳、睡眠、WPAI和疼痛的影响; 评估GSK1070806 200 MG在中度至重度ATD成人中的安全性和剂量范围内的安全性。
[Translation] Primary objective: To evaluate the efficacy of GSK1070806 200 MG compared with placebo in adults with moderate to severe ATD.
Secondary objectives: To evaluate the efficacy of GSK1070806 compared with placebo across the dose range by characterizing the longitudinal dose-response relationship in adults with moderate to severe ATD; to further evaluate the efficacy of GSK1070806 200 MG compared with placebo across the dose range in moderate to severe ATD. Effects in adults with severe ATD; To further evaluate the efficacy of GSK1070806 200 MG and the entire dose range versus placebo in adults with moderate to severe ATD; To further evaluate the efficacy of GSK1070806 200 MG and the entire dose range versus placebo in adults with moderate to severe ATD To evaluate the effect of GSK1070806 200 MG on health-related quality of life (HR-QOL), depression and anxiety, fatigue, sleep, WPAI, and pain as measured by a range of patient-reported outcomes PROs; Safety and safety within dose range.