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
1 other identifier
interventional
160
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2026
Shorter than P25 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2026
CompletedFirst Posted
Study publicly available on registry
March 11, 2026
CompletedStudy Start
First participant enrolled
March 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
March 11, 2026
February 1, 2026
11 months
March 8, 2026
March 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants achieving at least 75% improvement in Eczema Area and Severity Index (EASI 75)
At week 12
Secondary Outcomes (10)
Number of participants achieving at least 75% improvement in EASI (EASI 75)
At weeks 2, 4, 8
Number of participants achieving at least 50% or 90% improvement in EASI (EASI 50/90)
At weeks 2, 4, 8, 12
Number of participants achieving an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline
At weeks 2, 4, 8, 12
Number of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1
At weeks 2, 4, 8, 12
Number of participants achieving at least a 4-point reduction in Itch Numeric Rating Scale (Itch NRS) score from baseline
At weeks 2, 4, 8, 12
- +5 more secondary outcomes
Study Arms (4)
CMS-D001 50mg
EXPERIMENTALCMS-D001 100mg
EXPERIMENTALCMS-D001 200mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2026
First Posted
March 11, 2026
Study Start
March 20, 2026
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
March 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share