NCT04893707已完成2 期
An Open, Multicenter,Open-label Extension Study to Evaluate the Safety and Efficacy of CM310 in Patients With Atopic Dermatitis
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2021年6月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Number of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This is an open, multicenter, extension study evaluating the safety and efficacy of CM310 for long-term treatment in patients with atopic dermatitis The primary objective is to assess the long-term safety of CM310 administered in patients with atopic dermatitis (AD).
详细描述
The secondary objective of the study is to assess the immunogenicity of CM310 in patients with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in a prior clinical trial of CM310 for AD(CM310AD001 and CM310AD002) and met one of the following:
- •Participation in CM310AD001:received study treatment and adequately completed the assessments and completed the EOS(D85±7) visit.
- •Participation in CM310AD002 and met one of the following：i: Received study treatment and adequately completed the assessments and completed the EOS(V12) visit. ii:Treatment termination due to other reasons other than poor compliance or AE related to CM310 , completed the EOS visit .
- •Provide signed informed consent
排除标准
- •Patients who, during their participation in a previous CM310 clinical trial, developed a SAE/AE deemed related to dupilumab*, which in the opinion of the investigator or of the medical monitor could not suitable to continue the treatment with CM
- •Not enough washing-out period for previous therapy.
研究组 & 干预措施
CM310
Experimental
adults and teenagers (12 ~ 18 years) with weight ≥60 kg : 600mg for 1st dose, and then 300 mg, every 2 weeks and up to 1 year, SC.
teenagers (12 ~ 18 years) with weight ≥30 kg and <60kg : 400mg for 1st dose, and then 200 mg, every 2 weeks and up to 1 year, SC.
干预措施: CM310 (Biological)
结局指标
主要结局
Number of Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 2 Years
The primary endpoint in the study is the incidence and rate (events per patient-year) of TEAEs
次要结局
- Changes from baseline to prespecified time points through the end of the study: Dermatology Life Quality Index (DLQI)(Up to 2 Years)
- Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline of the parent study) at each visit(Up to 2 Years)
- Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and decline ≥2 points from baseline at each visit(Up to 2 Years)
- Number of Serious Adverse Events (SAEs) and Adverse Event of special interest(AESI)(Up to 2 Years)
- Change from baseline in EASI score at each visit(Up to 2 Years)
- Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥4 points from baseline(Up to 2 Years)
- Body Surface Area (BSA)(Up to 2 Years)
- Time to first relapse (eg, IGA >2) after remission or to not achieving remission(Up to 2 Years)
- Time to first EASI-50/75/90(Up to 2 Years)
- Proportion of patients requiring rescue treatment: Overall/Systemic treatment/Immunosuppressor/Systemic treatment(Up to 2 Years)
- immunogenicity(Up to 2 Years)
- Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline of the parent study) at each visit(Up to 2 Years)
- Time to first remission (achieving IGA = 0 or 1)(Up to 2 Years)
- Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 points from baseline(Up to 2 Years)
- Pharmacokinetics parameters(Up to 2 Years)
- Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline of the parent study) at each visit(Up to 2 Years)
- Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit(Up to 2 Years)
- Proportion of patients with IGA reduction from baseline of ≥2 points at each visit(Up to 2 Years)
- Percent change from baseline in NRS(Up to 2 Years)
- Number of days on topical medication (per patient-year)(Up to 2 Years)
研究者
研究点 (1)
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