A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 in Adult Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 28
- 主要终点
- Number of participants achieving at least 75% improvement in Eczema Area and Severity Index (EASI 75)
研究概览
简要总结
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial, aiming to evaluate the efficacy, safety, and tolerability of CMS-D001 in participants with moderate to severe atopic dermatitis, as well as to assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of CMS-D001 and its major metabolites (as applicable) in participants with moderate to severe atopic dermatitis, so as to provide a basis for the dosage of the Phase III confirmatory clinical trial.
详细描述
Approximately 160 participants with moderate to severe atopic dermatitis are planned to be enrolled and randomly assigned to four groups in a 1:1:1:1 ratio. Stratification will be performed based on participants' baseline IGA scores (3 or 4) at the time of randomization.
Each participant will receive study treatment once daily (QD) for 12 consecutive weeks. The dosage and frequency for each group are as follows:
Trial Group 1: CMS-D001 50 mg, QD; Trial Group 2: CMS-D001 100 mg, QD; Trial Group 3: CMS-D001 200 mg, QD; Control Group: Placebo, QD. The study is divided into three phases: a Screening Period (up to 4 weeks), a Treatment Period (12 weeks), and a Safety Follow-up Period (4 weeks after the last dose).
During the study, all participants must adhere to the study visit schedule to undergo efficacy and safety assessments. They will also be required to complete blood sample collections for Pharmacokinetic (PK) and Pharmacodynamic (PD) evaluations, and information regarding Adverse Events (AEs) and concomitant medications will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years, willing to sign the ICF
- •Clinical diagnosis of AD (Hanifin & Rajka criteria) for ≥1 year
- •At screening and baseline, EASI score ≥ 16 points, IGA ≥ 3, BSA ≥ 10%, Itch NRS ≥ 4
- •Documented history of inadequate response to topical corticosteroids (TCS) or -topical calcineurin inhibitors (TCI).
- •Subject has applied a topical emollient (moisturizer) daily for at least 7 days prior to the Baseline Visit.
排除标准
- •Other active skin conditions that may interfere with AD assessment.
- •History of a serious bacterial, fungal, or viral infection requiring hospitalization or intravenous antimicrobial therapy within 3 months prior to the first dose.
- •History of a bacterial, fungal, or viral infection requiring oral antimicrobial therapy within 4 weeks prior to the first dose.
- •Active infection or acute illness within 7 days prior to the first dose.
- •Chronic or recurrent infectious diseases at screening or baseline that may increase safety risks.
- •Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
- •History of a major or unstable clinical condition within 6 months prior to the first dose, which would compromise participation.
- •History of malignant tumour within 5 years before screening.
- •Previous or current autoimmune diseases.
- •Positive results of confirmatory test for hepatitis B, hepatitis C, human
- •immunodeficiency virus (HIV) or syphilis.
- •Allergic to any component of the investigational drug.
研究组 & 干预措施
CMS-D001 200mg
干预措施: CMS-D001 200mg (Drug)
Placebo
干预措施: Placebo (Drug)
CMS-D001 50mg
干预措施: CMS-D001 50mg (Drug)
CMS-D001 100mg
干预措施: CMS-D001 100mg (Drug)
结局指标
主要结局
Number of participants achieving at least 75% improvement in Eczema Area and Severity Index (EASI 75)
时间窗: At week 12
次要结局
- Percentage change in SCORing Atopic Dermatitis (SCORAD) score from baseline(At weeks 2, 4, 8, 12)
- Number of participants achieving at least 75% improvement in EASI (EASI 75)(At weeks 2, 4, 8)
- Number of participants achieving at least 50% or 90% improvement in EASI (EASI 50/90)(At weeks 2, 4, 8, 12)
- Number of participants achieving an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline(At weeks 2, 4, 8, 12)
- Number of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1(At weeks 2, 4, 8, 12)
- Number of participants achieving at least a 4-point reduction in Itch Numeric Rating Scale (Itch NRS) score from baseline(At weeks 2, 4, 8, 12)
- Percentage change in EASI score from baseline(At weeks 2, 4, 8, 12)
- Change in Itch Numeric Rating Scale (Itch NRS) score from baseline(At weeks 2, 4, 8, 12)
- Percentage change in affected Body Surface Area (BSA) from baseline(At weeks 2, 4, 8, 12)
- Change in Dermatology Life Quality Index (DLQI) score from baseline(At weeks 2, 4, 8, 12)