NCT06947980招募中2 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年6月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 24
研究概览
简要总结
A Phase 2 study designed to evaluate the efficacy and safety of CM512 in adult patients with moderate-to-severe Atopic Dermatitis (AD).
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
- Triple (Participant, 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
- •Patients with a diagnosis of AD for at least 1 year according to the American Academy of Dermatology's consensus criteria prior to the screening visit meeting all of the following criteria:
- •EASI≥16 at Screening and Baseline visits;
- •Investigator's Global Assessment (IGA) score of≥3 at Screening and Baseline visits;
- •10% Body Surface Area (BSA) of AD involvement at Screening and Baseline visits;
- •Mean of weekly Pruritus Numeric Rating Scale (NRS) severity score≥4 at Baseline;
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
Group 1
Placebo Comparator
干预措施: Placebo Comparator (Drug)
Group 2
Experimental
干预措施: CM512 (Biological)
Group 3
Experimental
干预措施: CM512 (Biological)
Group 4
Experimental
干预措施: CM512 (Biological)
Group 5
Placebo Comparator
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 24
时间窗: Baseline, Week 24
The EASI score is used to measure the severity and extent of AD and measured erythema, edema/papulation, excoriation and lichenification on 4 anatomic regions of the body: head and neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Safety and Efficacy Study of CNTO1275 in Patients With Multiple SclerosisMultiple SclerosisNCT00207727Centocor, Inc.249
进行中（未招募）
2 期
Phase II Study of PG-102(MG12) Compared With Placebo in Obesity and Type 2 DiabetesType 2 Diabetes Mellitus (T2DM)Obesity Type 2 Diabetes MellitusNCT06712615ProGen. Co., Ltd.144
已完成
2 期
A Clinical Study With MT-102 in Subjects With Cancer CachexiaCancer CachexiaNCT01238107Akamis Bio87
已完成
2 期
Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic DermatitisAtopic DermatitisNCT00980629Maruho Co., Ltd.
已完成
2 期
Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic DermatitisAtopic DermatitisNCT05432596Aclaris Therapeutics, Inc.250