[Translation] A multicenter, randomized, double-blind, parallel, positive-controlled phase III clinical trial evaluating the equivalence of GS101 injection versus dupilumab injection (Dapoxetine®) for the treatment of moderate to severe atopic dermatitis.
主要研究目的:
1) 验证GS101注射液与度普利尤单抗注射液(达必妥®)治疗中度至重度特应性皮炎患者疗效的相似性。
次要研究目的:
1) 基于次要疗效终点,评价GS101注射液与度普利尤单抗注射液(达必妥®)对中度至重度特应性皮炎患者的疗效。
2) 评价GS101注射液与度普利尤单抗注射液(达必妥®)对中度至重度特应性皮炎患者的安全性、耐受性;
3) 评价GS101注射液与度普利尤单抗注射液(达必妥®)在中度至重度特应性皮炎患者的免疫原性;
4) 评价GS101注射液与度普利尤单抗注射液(达必妥®)在中度至重度特应性皮炎患者中的群体药代动力学(PopPK)特征。
[Translation] Primary Study Objectives:
1) To verify the similarity of efficacy between GS101 injection and dupilumab injection (Dapixto®) in treating patients with moderate to severe atopic dermatitis.
Secondary Study Objectives:
1) To evaluate the efficacy of GS101 injection and dupilumab injection (Dapixto®) in patients with moderate to severe atopic dermatitis based on secondary efficacy endpoints.
2) To evaluate the safety and tolerability of GS101 injection and dupilumab injection (Dapixto®) in patients with moderate to severe atopic dermatitis.
3) To evaluate the immunogenicity of GS101 injection and dupilumab injection (Dapixto®) in patients with moderate to severe atopic dermatitis.
4) To evaluate the population pharmacokinetic (PopPK) characteristics of GS101 injection and dupilumab injection (Dapixto®) in patients with moderate to severe atopic dermatitis.