A Randomized, Double Blind, Placebo-controlled, Multiple Dose Escalation, Phase Ib/IIa Study to Evaluate the Safety, Tolerance, PK, PD, Immunogenicity and Preliminary Efficacy of Subcutaneously CM310 in Moderate-severe AD Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 7
- 主要终点
- Safety parameters (e.g., Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing)
研究概览
简要总结
This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of subcutaneously CM310 in moderate-severe AD subjects.
详细描述
The study consists of 3 periods, a up-to-4-week Screening Period, a 4-week randomized Treatment Period and a 8-week Safety Follow-up Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as AD for at least 12 months before Screening, with below requirements: 1)EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 (0-5 points scale) at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.
- •Inadequate response to topical medications.
排除标准
- •Not enough washing-out period for previous therapy.
- •Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- •Organ dysfunction.
- •Pregnancy.
研究组 & 干预措施
CM310 75mg arm
75mg for 3 doses, every 2 weeks, SC
干预措施: CM310 (Drug)
CM310 150mg arm
150mg for 3 doses, every 2 weeks, SC
干预措施: CM310 (Drug)
CM310 300mg arm
300mg for 3 doses, every 2 weeks, SC
干预措施: CM310 (Drug)
CM310 600(1st)+300mg(2nd,3rd) arm
600mg for 1st dose, and then 300 mg for 2nd and 3rd doses, every 2 weeks, SC
干预措施: CM310 (Drug)
placebo arm
placebo for 3 doses, every 2 weeks, SC
干预措施: Placebo (Drug)
结局指标
主要结局
Safety parameters (e.g., Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing)
时间窗: Baseline to Week 12
Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
次要结局
- Preliminary efficacy: Proportion of subjects with IGA 0 or 1(Baseline to Week 12)
- Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to t (AUC0-t)(Baseline to Week 12)
- Pharmacodynamics parameters: Total IgE level(Baseline to Week 12)
- Pharmacodynamics parameters: Serum Thymus and activation regulated chemokine (TARC)(Baseline to Week 12)
- Pharmacodynamics parameters: Blood eosinophil count (EOS)(Baseline to Week 12)
- Preliminary efficacy: Proportion of subjects with EASI-75(Baseline to Week 12)
- Pharmacokinetics parameter: Peak concentration (Cmax)(Baseline to Week 12)
- Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)(Baseline to Week 12)
- Pharmacokinetics parameter: Clearance rate (CL/F)(Baseline to Week 12)
- Immunogenicity: Proportion of subjects with anti-drug antibody (ADA)(Baseline to Week 12)
- Preliminary efficacy: Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points(Baseline to Week 12)
- Preliminary efficacy: Proportion of subjects with improvement (reduction) of pruritus NRS from baseline(Baseline to Week 12)
- Preliminary efficacy: Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points(Baseline to Week 12)
- Preliminary efficacy: Proportion of subjects with EASI-50(Baseline to Week 12)