Tests CMS-D001 for moderate to severe atopic dermatitis in adults
Tests CMS-D001 against placebo in adults with moderate to severe atopic dermatitis.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Beijing, Binzhou, Chengdu, Fuzhou, Guangzhou, Haikou, Hangzhou, Jinan, Shanghai, Shenyang, Shenzhen, Shijiazhuang, Shiyan, Suzhou, Tangshan, Tianjin, Wuhan, Xi'an, Yinchuan, Zhengzhou, and Zhenjiang, ChinaSee the 28 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07465120, who can take part
Where in China
- Beijing Huairou HospitalBeijing, ChinaNo longer taking part
- Beijing Tongren Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
- China-Japan Friendship HospitalBeijing, ChinaNo longer taking part
- Affiliated Hospital of Binzhou Medical UniversityBinzhou, ChinaNo longer taking part
- Sichuan Provincial People's HospitalChengdu, ChinaNo longer taking part
- West China Hospital of Sichuan UniversityChengdu, ChinaNo longer taking part
- First Affiliated Hospital of Fujian Medical UniversityFuzhou, ChinaNo longer taking part
- Southern Medical University Dermatology HospitalGuangzhou, ChinaNo longer taking part
- Hainan Provincial Fifth People's HospitalHaikou, ChinaNo longer taking part
- Hangzhou No.1 People's HospitalHangzhou, ChinaNo longer taking part
- Hangzhou Third People's HospitalHangzhou, ChinaNo longer taking part
- Zhejiang Provincial People's HospitalHangzhou, ChinaNo longer taking part
- Qilu Hospital of Shandong UniversityJinan, ChinaNo longer taking part
- Shanghai Dermatology HospitalShanghai, ChinaNo longer taking part
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese MedicineShanghai, ChinaNo longer taking part
- Affiliated Central Hospital of Shenyang Medical CollegeShenyang, ChinaNo longer taking part
- Shenyang Hospital of Integrated Traditional Chinese and Western MedicineShenyang, ChinaNo longer taking part
- Peking University Shenzhen HospitalShenzhen, ChinaNo longer taking part
- Hebei Medical University Second HospitalShijiazhuang, ChinaNo longer taking part
- Shiyan People's HospitalShiyan, ChinaNo longer taking part
- Suzhou Municipal HospitalSuzhou, ChinaNo longer taking part
- Affiliated Hospital of North China University of Science and TechnologyTangshan, ChinaNo longer taking part
- Tianjin Medical University General HospitalTianjin, ChinaNo longer taking part
- Wuhan NO.1 HospitalWuhan, ChinaNo longer taking part
- Shaanxi provincial people's hospitalXi'an, ChinaNo longer taking part
- General Hospital of Ningxia Medical UniversityYinchuan, ChinaNo longer taking part
- Zhengzhou Central HospitalZhengzhou, ChinaNo longer taking part
- Affiliated Hospital of Jiangsu UniversityZhenjiang, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Dermavon Holdings Limited
- Trial code
- NCT07465120
- Record updated
- 11 March 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; History of a major or unstable clinical condition within 6 months prior to the first dose, which would compromise participation; Previous or current autoimmune diseases; Allergic to any component of the investigational drug; Other active skin conditions that may interfere with AD assessment; 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 malignant tumour within 5 years before screening; Positive results of confirmatory test for hepatitis B, hepatitis C, human; immunodeficiency virus (HIV) or syphilis.