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

March 8, 2026 updated by: Dermavon Holdings Limited
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Approximately 160 participants with moderate to severe atopic dermatitis are planned to be enrolled and randomly assigned to four groups in a 1:1:1:1 ratio. Stratification will be performed based on participants' baseline IGA scores (3 or 4) at the time of randomization.

Each participant will receive study treatment once daily (QD) for 12 consecutive weeks. The dosage and frequency for each group are as follows:

Trial Group 1: CMS-D001 50 mg, QD; Trial Group 2: CMS-D001 100 mg, QD; Trial Group 3: CMS-D001 200 mg, QD; Control Group: Placebo, QD. The study is divided into three phases: a Screening Period (up to 4 weeks), a Treatment Period (12 weeks), and a Safety Follow-up Period (4 weeks after the last dose).

During the study, all participants must adhere to the study visit schedule to undergo efficacy and safety assessments. They will also be required to complete blood sample collections for Pharmacokinetic (PK) and Pharmacodynamic (PD) evaluations, and information regarding Adverse Events (AEs) and concomitant medications will be collected.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Beijing Tongren Hospital, Capital Medical University
        • Contact:
          • Wei Aihua Beijing Tongren Hospital, Capital Medical University
          • Phone Number: 15810585889
          • Email: weiaihua3000@163.com
      • Beijing, Beijing Municipality, China
        • China-Japan Friendship Hospital
        • Contact:
      • Beijing, Beijing Municipality, China
        • Beijing Huairou Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
        • First Affiliated Hospital of Fujian Medical University
        • Contact:
          • Xiang Niu First Affiliated Hospital of Fujian Medical University
          • Phone Number: 13696834928
          • Email: drnewnew@sina.com
    • Guangdong
      • Guangzhou, Guangdong, China
        • Southern Medical University Dermatology Hospital
        • Contact:
          • Zhu Guannan Southern Medical University Dermatology Hospital
          • Phone Number: 13750837205
          • Email: 18957118053@163.com
      • Shenzhen, Guangdong, China
        • Peking University Shenzhen Hospital
        • Contact:
          • Dou Xia Peking University Shenzhen Hospital
          • Phone Number: 13600156947
          • Email: douxiaderm@163.com
    • Hainan
      • Haikou, Hainan, China
        • Hainan Provincial Fifth People's Hospital
        • Contact:
          • Zeng Huiming Hainan Provincial No.5 People's Hospital
          • Phone Number: 13976598200
          • Email: 13976598200@163.com
    • Hebei
      • Shijiazhuang, Hebei, China
        • Hebei Medical University Second Hospital
        • Contact:
          • Li Yanling Hebei Medical University Second Hospital
          • Phone Number: 15803212590
          • Email: lyldoctor@sina.com
      • Tangshan, Hebei, China
        • Affiliated Hospital of North China University of Science and Technology
        • Contact:
          • Sun Lindan Affiliated Hospital of North China University of Science and T
          • Phone Number: 13856985045
          • Email: ahmusld@163.com
    • Henan
      • Zhengzhou, Henan, China
        • Zhengzhou Central Hospital
        • Contact:
    • Hubei
      • Shiyan, Hubei, China
        • Shiyan People's Hospital
        • Contact:
          • Meng Xiangdong Shiyan People's Hospital
          • Phone Number: 13997837543
          • Email: 1970547910@qq.com
      • Wuhan, Hubei, China
        • Wuhan No.1 Hospital
        • Contact:
          • Shi Yuling Wuhan No.1 Hospital
          • Phone Number: 13971394978
          • Email: chlq35@126.com
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Suzhou Municipal Hospital
        • Contact:
          • Gu Jun Suzhou Municipal Hospital
          • Phone Number: 18930939371
          • Email: guijun79@163.com
      • Zhenjiang, Jiangsu, China
        • Affiliated Hospital of Jiangsu University
        • Contact:
          • Li Yumei Affiliated Hospital of Jiangsu University
          • Phone Number: 13914569541
          • Email: l_yumei@aliyun.com
    • Liaoning
      • Shenyang, Liaoning, China
        • Affiliated Central Hospital of Shenyang Medical College
        • Contact:
          • Li Xiaodong Affiliated Central Hospital of Shenyang Medical
          • Phone Number: 18002478468
          • Email: lilicmu@163.com
      • Shenyang, Liaoning, China
        • Shenyang Hospital of Integrated Traditional Chinese and Western Medicine
        • Contact:
          • Wang Zhen Shenyang Hospital of Integrated Traditional Chinese and Weste
          • Phone Number: 13840565336
          • Email: drwz1991@163.com
    • Ningxia
      • Yinchuan, Ningxia, China
        • General Hospital of Ningxia Medical University
        • Contact:
          • Xinhong Ge General Hospital of Ningxia Medical University
          • Phone Number: 13895011119
          • Email: Gexinhong.0101@163.com
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Shaanxi Provincial People's Hospital
        • Contact:
          • Yang Li Shaanxi Provincial People's Hospital
          • Phone Number: 18681857989
          • Email: 27568300@qq.com
    • Shandong
      • Binzhou, Shandong, China
        • Affiliated Hospital of Binzhou Medical University
        • Contact:
          • Ma Lei Affiliated Hospital of Binzhou Medical University
          • Phone Number: 13905430770
          • Email: doctor_malei@126.com
      • Jinan, Shandong, China
        • Qilu Hospital of Shandong University
        • Contact:
          • Li Ying Qilu Hospital of Shandong University
          • Phone Number: 18560085070
          • Email: 1145241793@qq.com
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Shanghai Dermatology Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
        • Contact:
          • Li Xin Yueyang Hospital of Integrated Traditional Chinese and Wester
          • Phone Number: 18917111603
          • Email: 13661956326@163.com
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital of Sichuan University
        • Contact:
      • Chengdu, Sichuan, China
        • Sichuan Provincial People's Hospital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Tianjin Medical University General Hospital
        • Contact:
          • Wang Huiping Tianjin Medical University General Hospital
          • Phone Number: 13702031042
          • Email: who1109@163.com
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Provincial People's Hospital
        • Contact:
          • Wu Liming Zhejiang Provincial People's Hospital
          • Phone Number: 13505811700
          • Email: 13505811700@163.com
      • Hangzhou, Zhejiang, China
        • Hangzhou Third People's Hospital
        • Contact:
          • Liu Zequan Hangzhou Third People's Hospital
          • Phone Number: 13758207597
          • Email: hzzehuliu@163.com
      • Hangzhou, Zhejiang, China
        • Hangzhou No.1 People's Hospital
        • Contact:
          • Wu Liming Hangzhou No.1 People's Hospital
          • Phone Number: 13750837205
          • Email: 18957118053@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo QD
Experimental: CMS-D001 50mg
Drug: CMS-D001 50mg
CMS-D001 50mg QD
Experimental: CMS-D001 100mg
Drug: CMS-D001 100mg
CMS-D001 100mg QD
Experimental: CMS-D001 200mg
Drug: CMS-D001 200mg
CMS-D001 200mg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants achieving at least 75% improvement in Eczema Area and Severity Index (EASI 75)
Time Frame: At week 12
At week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants achieving at least 75% improvement in EASI (EASI 75)
Time Frame: At weeks 2, 4, 8
At weeks 2, 4, 8
Number of participants achieving at least 50% or 90% improvement in EASI (EASI 50/90)
Time Frame: At weeks 2, 4, 8, 12
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
Time Frame: At weeks 2, 4, 8, 12
At weeks 2, 4, 8, 12
Number of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1
Time Frame: At weeks 2, 4, 8, 12
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
Time Frame: At weeks 2, 4, 8, 12
At weeks 2, 4, 8, 12
Percentage change in EASI score from baseline
Time Frame: At weeks 2, 4, 8, 12
At weeks 2, 4, 8, 12
Percentage change in SCORing Atopic Dermatitis (SCORAD) score from baseline
Time Frame: At weeks 2, 4, 8, 12
At weeks 2, 4, 8, 12
Change in Itch Numeric Rating Scale (Itch NRS) score from baseline
Time Frame: At weeks 2, 4, 8, 12
At weeks 2, 4, 8, 12
Percentage change in affected Body Surface Area (BSA) from baseline
Time Frame: At weeks 2, 4, 8, 12
At weeks 2, 4, 8, 12
Change in Dermatology Life Quality Index (DLQI) score from baseline
Time Frame: At weeks 2, 4, 8, 12
At weeks 2, 4, 8, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dermavon Holdings Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

March 8, 2026

First Submitted That Met QC Criteria

March 8, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 8, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • D001-02-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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