Moderate to Severe Atopic DermatitisPhase 2NCT07465120
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
A Phase 2 study testing CMS-D001 50mg, CMS-D001 100mg and CMS-D001 200mg in people with Moderate to Severe Atopic Dermatitis, run by Dermavon Holdings Limited at 28 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Atopic Dermatitis
- What is being tested?
- CMS-D001 50mg, CMS-D001 100mg and CMS-D001 200mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 28 sitesChina
- Study dates
- 20 Mar 2026to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
China28 sites
Beijing Huairou Hospital
Beijing, Beijing Municipality
Zhang Haihong Beijing Huairou Hospital, 13811261579, m13811261579@163.com
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality
Wei Aihua Beijing Tongren Hospital, Capital Medical University, 15810585889, weiaihua3000@163.com
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Cui Yong China-Japan Friendship Hospital, 15701625913, wuhucuiyong@vip.163.com
Affiliated Hospital of Binzhou Medical University
Binzhou, Shandong
Ma Lei Affiliated Hospital of Binzhou Medical University, 13905430770, doctor_malei@126.com
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Zhang Lixia Sichuan Provincial People's Hospital, 17708130396, zhanglixia_17561@163.com
West China Hospital of Sichuan University
Chengdu, Sichuan
Li Wei West China Hospital of Sichuan University, 18980601695, liweihx_hxyy@scu.edu.cn
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Xiang Niu First Affiliated Hospital of Fujian Medical University, 13696834928, drnewnew@sina.com
Southern Medical University Dermatology Hospital
Guangzhou, Guangdong
Zhu Guannan Southern Medical University Dermatology Hospital, 13750837205, 18957118053@163.com
Hainan Provincial Fifth People's Hospital
Haikou, Hainan
Zeng Huiming Hainan Provincial No.5 People's Hospital, 13976598200, 13976598200@163.com
Hangzhou No.1 People's Hospital
Hangzhou, Zhejiang
Wu Liming Hangzhou No.1 People's Hospital, 13750837205, 18957118053@163.com
Hangzhou Third People's Hospital
Hangzhou, Zhejiang
Liu Zequan Hangzhou Third People's Hospital, 13758207597, hzzehuliu@163.com
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Wu Liming Zhejiang Provincial People's Hospital, 13505811700, 13505811700@163.com
Qilu Hospital of Shandong University
Jinan, Shandong
Li Ying Qilu Hospital of Shandong University, 18560085070, 1145241793@qq.com
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality
Shi Yuling Shanghai Dermatology Hospital, 13816213884, shiyuling1973@tongji.edu.cn
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality
Li Xin Yueyang Hospital of Integrated Traditional Chinese and Wester, 18917111603, 13661956326@163.com
Affiliated Central Hospital of Shenyang Medical College
Shenyang, Liaoning
Li Xiaodong Affiliated Central Hospital of Shenyang Medical, 18002478468, lilicmu@163.com
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine
Shenyang, Liaoning
Wang Zhen Shenyang Hospital of Integrated Traditional Chinese and Weste, 13840565336, drwz1991@163.com
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Dou Xia Peking University Shenzhen Hospital, 13600156947, douxiaderm@163.com
Hebei Medical University Second Hospital
Shijiazhuang, Hebei
Li Yanling Hebei Medical University Second Hospital, 15803212590, lyldoctor@sina.com
Shiyan People's Hospital
Shiyan, Hubei
Meng Xiangdong Shiyan People's Hospital, 13997837543, 1970547910@qq.com
Suzhou Municipal Hospital
Suzhou, Jiangsu
Gu Jun Suzhou Municipal Hospital, 18930939371, guijun79@163.com
Affiliated Hospital of North China University of Science and Technology
Tangshan, Hebei
Sun Lindan Affiliated Hospital of North China University of Science and T, 13856985045, ahmusld@163.com
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Wang Huiping Tianjin Medical University General Hospital, 13702031042, who1109@163.com
Wuhan No.1 Hospital
Wuhan, Hubei
Shi Yuling Wuhan No.1 Hospital, 13971394978, chlq35@126.com
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi
Yang Li Shaanxi Provincial People's Hospital, 18681857989, 27568300@qq.com
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Xinhong Ge General Hospital of Ningxia Medical University, 13895011119, Gexinhong.0101@163.com
Zhengzhou Central Hospital
Zhengzhou, Henan
Chen Zixue, 13938459676, zxwygcp0371@163.com
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu
Li Yumei Affiliated Hospital of Jiangsu University, 13914569541, l_yumei@aliyun.com
About this study
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 the 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.
- Conditions
- Moderate to Severe Atopic Dermatitis
- Being tested
- CMS-D001 50mg, CMS-D001 100mg, CMS-D001 200mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMS-D001 50mgDrug
CMS-D001 50mg QD
CMS-D001 100mgDrug
CMS-D001 100mg QD
CMS-D001 200mgDrug
CMS-D001 200mg QD
PlaceboDrug
Placebo QD
| Study group | Role | What they receive |
|---|---|---|
| CMS-D001 50mg | Experimental | Not described Receives: Drug: CMS-D001 50mg |
| CMS-D001 100mg | Experimental | Not described Receives: Drug: CMS-D001 100mg |
| CMS-D001 200mg | Experimental | Not described Receives: Drug: CMS-D001 200mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants achieving at least 75% improvement in Eczema Area and Severity Index (EASI 75)
Measured: At week 12
Secondary outcomes (10)
Number of participants achieving at least 75% improvement in EASI (EASI 75)
Measured: At weeks 2, 4, 8
Number of participants achieving at least 50% or 90% improvement in EASI (EASI 50/90)
Measured: 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
Measured: At weeks 2, 4, 8, 12
Number of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1
Measured: 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
Measured: At weeks 2, 4, 8, 12
Percentage change in EASI score from baseline
Measured: At weeks 2, 4, 8, 12
Percentage change in SCORing Atopic Dermatitis (SCORAD) score from baseline
Measured: At weeks 2, 4, 8, 12
Change in Itch Numeric Rating Scale (Itch NRS) score from baseline
Measured: At weeks 2, 4, 8, 12
Percentage change in affected Body Surface Area (BSA) from baseline
Measured: At weeks 2, 4, 8, 12
Change in Dermatology Life Quality Index (DLQI) score from baseline
Measured: At weeks 2, 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dermavon Holdings Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465120
- Sponsor's protocol ID
- D001-02-001
- Status last verified
- Feb 2026
- First submitted
- 8 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07465120
- Acronym / sponsor ID
- D001-02-001
- Conditions
- Moderate to Severe Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Dermavon Holdings LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CMS-D001 50mg | Experimental | Drug: CMS-D001 50mg |
| CMS-D001 100mg | Experimental | Drug: CMS-D001 100mg |
| CMS-D001 200mg | Experimental | Drug: CMS-D001 200mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMS-D001 50mgCMS-D001 50mg QD | Drug | CMS-D001 50mg |
| CMS-D001 100mgCMS-D001 100mg QD | Drug | CMS-D001 100mg |
| CMS-D001 200mgCMS-D001 200mg QD | Drug | CMS-D001 200mg |
| PlaceboPlacebo QD | Drug | Placebo |
Primary outcome
Number of participants achieving at least 75% improvement in Eczema Area and Severity Index (EASI 75)
Time frame: At week 12
10 secondary outcomes
Number of participants achieving at least 75% improvement in EASI (EASI 75)
Time frame: 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
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
Number of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1
Time frame: 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
Percentage change in EASI score from baseline
Time frame: At weeks 2, 4, 8, 12
Percentage change in SCORing Atopic Dermatitis (SCORAD) score from baseline
Time frame: 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
Percentage change in affected Body Surface Area (BSA) from baseline
Time frame: At weeks 2, 4, 8, 12
Change in Dermatology Life Quality Index (DLQI) score from baseline
Time frame: At weeks 2, 4, 8, 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CMS-D001 50mg, CMS-D001 100mg and CMS-D001 200mg in people with Moderate to Severe Atopic Dermatitis, run by Dermavon Holdings Limited at 28 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants achieving at least 75% improvement in Eczema Area and Severity Index (EASI 75) (time frame: At week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.