跳至主要内容
临床试验/NCT07230483
NCT07230483招募中2 期

An Open-Label, Multicenter Study to Evaluate Long-Term Safety and Efficacy of CM512 in Atopic Dermatitis Patients.

Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2025年12月1日最近更新:
干预措施

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
246
试验地点
1
主要终点
Adverse events

研究概览

简要总结

This is an Open-label ,Multicenter Study to evaluate Long-Term Safety and Efficacy of CM512 in patients with Atopic Dermatitis who have completed treatment in parent CM512 Study.

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
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

入选标准

  • Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
  • Subjects who have completed the week 18 evaluation in the parent study CM512-101102 or the End of Study(EOS) visit in the parent study CM512-100001.

排除标准

  • Not enough washing-out period for previous therapy.
  • Any other condition assessed by the investigator that makes participants unsuitable for participation in this study.

研究组 & 干预措施

Group 1

Experimental

干预措施: CM512 (Biological)

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)

结局指标

主要结局

Adverse events

时间窗: up to 52 weeks

The incidence of adverse events

次要结局

未报告次要终点

研究者

发起方
Keymed Biosciences Co.Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

A Long-term Safety and Efficacy Study Evaluating... | 临床试验