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Clinical Trials in China / NCT07465120
Starting soon Phase 2

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

NCT07465120 · tracked via the Priya Life Science China tracker
Sponsor
Dermavon Holdings Limited
Phase
Phase 2
Started
2026-03-20
Last updated
2026-03-11

Condition(s) studied

Moderate to Severe Atopic Dermatitis

Investigational drug(s) / intervention(s)

CMS-D001 50mgCMS-D001 100mgCMS-D001 200mgPlacebo

CMS-D001 50mg: CMS-D001 50mg QD

CMS-D001 100mg: CMS-D001 100mg QD

CMS-D001 200mg: CMS-D001 200mg QD

Placebo: Placebo QD

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
Beijing Huairou Hospital Beijing Beijing Municipality
Beijing Tongren Hospital, Capital Medical University Beijing Beijing Municipality
China-Japan Friendship Hospital Beijing Beijing Municipality
First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
Southern Medical University Dermatology Hospital Guangzhou Guangdong
Peking University Shenzhen Hospital Shenzhen Guangdong
Hainan Provincial Fifth People's Hospital Haikou Hainan
Hebei Medical University Second Hospital Shijiazhuang Hebei
Affiliated Hospital of North China University of Science and Technology Tangshan Hebei
Zhengzhou Central Hospital Zhengzhou Henan
Shiyan People's Hospital Shiyan Hubei
Wuhan No.1 Hospital Wuhan Hubei
Suzhou Municipal Hospital Suzhou Jiangsu
Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu
Affiliated Central Hospital of Shenyang Medical College Shenyang Liaoning
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine Shenyang Liaoning
General Hospital of Ningxia Medical University Yinchuan Ningxia
Shaanxi Provincial People's Hospital Xi'an Shaanxi
Affiliated Hospital of Binzhou Medical University Binzhou Shandong
Qilu Hospital of Shandong University Jinan Shandong
Shanghai Dermatology Hospital Shanghai Shanghai Municipality
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine Shanghai Shanghai Municipality
Sichuan Provincial People's Hospital Chengdu Sichuan
West China Hospital of Sichuan University Chengdu Sichuan
Tianjin Medical University General Hospital Tianjin Tianjin Municipality
Hangzhou No.1 People's Hospital Hangzhou Zhejiang
Hangzhou Third People's Hospital Hangzhou Zhejiang
Zhejiang Provincial People's Hospital Hangzhou Zhejiang

More Dermavon Holdings Limited trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07465120 on ClinicalTrials.gov ↗ ← All trials in China