[Translation] A multicenter, randomized, double-blind, placebo-controlled, two-stage Phase II clinical trial to evaluate the safety, efficacy, pharmacokinetic and pharmacodynamic characteristics, and immunogenicity of XKH001 injection in the treatment of adult patients with moderate to severe atopic dermatitis
主要目的:
1、 评估XKH001在中重度AD成人患者中的安全性;
2、评估XKH001在第16周对中重度AD成人患者的疗效。
次要目的:
1、评估XKH001在第16周及其他访视点对中重度AD成人患者临床症状、体征和生活质量的疗效(生活质量仅在本试验第二阶段进行评估);
2、评估XKH001在中重度AD成人患者中的药代动力学(PK)特征;
3、评估XKH001在中重度AD成人患者中的药效动力学(PD)特征;
4、评估XKH001在中重度AD成人患者中的免疫原性;
5、分析XKH001在中重度AD成人患者中的药物暴露与临床疗效的关系(E-R)(仅在本试验第二阶段进行分析)。
探索性目的:
1、探索中重度AD成人患者皮肤组织中的生物标志物与XKH001疗效的关系。
[Translation] Main objectives:
1. To evaluate the safety of XKH001 in adult patients with moderate to severe AD;
2. To evaluate the efficacy of XKH001 in adult patients with moderate to severe AD at week 16.
Secondary objectives:
1. To evaluate the efficacy of XKH001 on clinical symptoms, signs and quality of life in adult patients with moderate to severe AD at week 16 and other visit points (quality of life is only evaluated in the second phase of this trial);
2. To evaluate the pharmacokinetic (PK) characteristics of XKH001 in adult patients with moderate to severe AD;
3. To evaluate the pharmacodynamic (PD) characteristics of XKH001 in adult patients with moderate to severe AD;
4. To evaluate the immunogenicity of XKH001 in adult patients with moderate to severe AD;
5. To analyze the relationship between drug exposure and clinical efficacy (E-R) of XKH001 in adult patients with moderate to severe AD (analyzed only in the second phase of this trial).
Exploratory objectives:
1. To explore the relationship between biomarkers in skin tissue of adult patients with moderate to severe AD and the efficacy of XKH001.