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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Moderate to Severe Atopic Dermatitis

In brief

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 facts

Study ID

NCT07465120

Run by

Dermavon Holdings Limited

People needed

160

Starts

2026-03-20

Expected to finish

2027-05-31

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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