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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
Sponsor: Dermavon Holdings Limited
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-03-20
Completion Date
2027-05-31
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
CMS-D001 50mg
CMS-D001 50mg QD
CMS-D001 100mg
CMS-D001 100mg QD
CMS-D001 200mg
CMS-D001 200mg QD
Placebo
Placebo QD
Locations (28)
Beijing Huairou Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Southern Medical University Dermatology Hospital
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Hainan Provincial Fifth People's Hospital
Haikou, Hainan, China
Hebei Medical University Second Hospital
Shijiazhuang, Hebei, China
Affiliated Hospital of North China University of Science and Technology
Tangshan, Hebei, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Shiyan People's Hospital
Shiyan, Hubei, China
Wuhan No.1 Hospital
Wuhan, Hubei, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Affiliated Central Hospital of Shenyang Medical College
Shenyang, Liaoning, China
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Affiliated Hospital of Binzhou Medical University
Binzhou, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Hangzhou No.1 People's Hospital
Hangzhou, Zhejiang, China
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China