NCT05186922Unknown1 期
A Randomized, Double Blind, Placebo-Controlled, Multiple Dose Escalation, Phase 2 Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Efficacy of CM326 in Patients With Moderate-severe Atopic Dermatitis Subjects
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2022年2月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AE)
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 CM326 in moderate-severe AD subjects.
详细描述
The study consists of 3 periods, a up-to-4-week Screening Period, a 12-week randomized Treatment Period and a 12-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
- •With confirmed Atopic Dermatitis (AD) at least 12 months before the screening
- •Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline
- •Investigator's Global Assessment (IGA) score ≥3 at screening and baseline
- •Body Surface Area (BSA) of involvement of atopic dermatitis ≥10% at screening and baseline
- •The weekly mean score of daily peaks in pruritus NRS at baseline ≥4
- •Provide signed informed consent
排除标准
- •Not enough washing-out period for previous therapy.
- •Presence of other concomitant and poorly controlled serious diseases or recurrent chronic diseases, including but not limited to active infections, cardiovascular and cerebrovascular diseases, pulmonary tuberculosis or other pathogen infections, diabetes mellitus, autoimmune diseases, human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or parasitosis, neoplasm malignant, etc.
- •Patients with severe hepatic or renal impairment, characterized by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 2 times of upper limit of normal (ULN), total bilirubin >1.5 times of upper limit of normal (ULN) or serum creatinine level > upper limit of normal (ULN).
- •Womens who are pregnant or breastfeeding, or who plan to become pregnant during the study.
结局指标
主要结局
Incidence of Adverse Events (AE)
时间窗: Up to week 24
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
次要结局
- Pharmacokinetics (PK) parameter : Elimination half life (T1/2z)(Up to Week 24)
- Body surface area (BSA) of involvement of atopic dermatitis(Up to Week 24)
- Changes from baseline in Dermatology Life Quality Index (DLQI) at each visit(Up to Week 24)
- Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)(Up to Week 24)
- Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)(Up to Week 24)
- Pharmacodynamics (PD): Changes from baseline in eosinophil count after CM326 administration(Up to Week 24)
- Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve (AUC)(Up to Week 24)
- Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration(Up to Week 24)
- Pharmacodynamics (PD): Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration(Up to Week 24)
- Pharmacodynamics (PD): Changes from baseline in serum periostin concentration after CM326 administration(Up to Week 24)
- Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline) at each visit(Up to Week 24)
- Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at each visit(Up to Week 24)
- Pharmacokinetics (PK) parameter : Clearance rate (CL/F)(Up to Week 24)
- Pharmacodynamics (PD): Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration(Up to Week 24)
- Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)(Up to Week 24)
- Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit(Up to Week 24)
- Change from baseline in Eczema Area and Severity Index (EASI) score at each visit(Up to Week 24)
- Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline) at each visit(Up to Week 24)
- Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 and ≥4 points from baseline(Up to Week 24)
- Percent change from baseline in Numerical Rating Scale (NRS)(Up to Week 24)
- Pharmacodynamics (PD): Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration(Up to Week 24)
- Proportion of patients with IGA reduction from baseline of ≥2 points at each visit(Up to Week 24)
研究者
研究点 (1)
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