Moderate to Severe Plaque PsoriasisPhase 2/3NCT07432854
A Clinical Study Evaluating the Efficacy and Safety of CMS-D001 Tablets in the Treatment of Adult Patients With Moderate to Severe Plaque-type Psoriasis
A Phase 2/3 study testing CMS-D001 50mg and CMS-D001 100mg in people with Moderate to Severe Plaque Psoriasis, run by Dermavon Holdings Limited at 21 sites in China.
Trial summary
This study adopted a multicenter, randomized, double-blind, placebo-controlled phase II/III operation seamless adaptive design, aiming to evaluate the efficacy, safety and tolerability of CMS-D001 tablets in the treatment of patients with moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- CMS-D001 50mg and CMS-D001 100mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 21 sitesChina
- Study dates
- 3 Mar 2026to 30 Jul 2028
- Phase
- Phase 2/3
- 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
- Diagnosed with plaque psoriasis for at least 6 months prior to screening.
- At screening and baseline, PASI score ≥ 12 points, BSA ≥ 10%, sPGA ≥ 3
- Be eligible for phototherapy or systemic therapy.
Who cannot join
- Non-plaque psoriasis (ie, guttate, pustular, erythrodermic, or inverse psoriasis) within 3 months prior to baseline.
- Other skin diseases at screening or baseline Drug-induced psoriasis.
- History of severe herpes zoster or severe herpes simplex or current herpes simplex/zoster infection.
- 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, in the investigator's judgment, may increase safety risks.
Show all 12Show fewer
- 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.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
China21 sites
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing
AiHua Wei, +86 15810585889, weiaihua3000@163.com
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
CongJun Jiang, +86 15155281266, congjun.jiang@bbmc.edu.cn
The First Hospital of Jilin University
Changchun, Jilin
ShanShan Li, +86 13756661632, shansalee@163.com
Affiliated Hospital of Chengde Medical College
Chengde, Hebei
XinSuo Duan, +86 15633142680 ext. 15633142680@16, 15633142680@163.com
Southern Medical University Dermatology Hospital
Guangzhou, Guangdong
Bin Yang, +86 13922207231, yangbin101@hotmail.com
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
XiangBin Mi, +86 18620152349, mitaiyang@163.com
Affiliated Hospital of Hebei University of Engineering
Handan, Hebei
GuoYing Miao, +86 18031028050, guoyingmiao@163.com
Hangzhou First People's Hospital
Hangzhou, Zhejiang
LiMing Wu, +86 13750837205, 18957118053@163.com
Hangzhou Third People's Hospital
Hangzhou, Zhejiang
YunYun Shan, +86 13858080025, shanyunyun7@163.com
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
XiaoHua, Tao, +86 13505811700, 13505811700@163.com
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
BingXue Bai, +86 15114517408, bxuebdd@163.com
Shandong First Medical University Affiliated Dermatology Hospital
Jinan, Shangdong
FuRen Zhang, +86 136 0892 1718, zhangfuren@hotmail.com
Jining First People's Hospital
Jining, Shandong
DongMei Shi, + 15069760108, shidongmei28@163.com
Nanyang Central Hospital
Nanyang, Henan
KunPeng Bian, +86 15936139975, bkp2008@163.com
Sanmenxia Central Hospital
Sanmenxia, Henan
Danhong Jiao, +86 13525892448, jiaodanhong@126.com
Shanghai Dermatology Hospital
Shanghai
YuLing Shi, +86 18917683882, shiyuling1016@163.com
Shijiazhuang Traditional Chinese Medicine Hospital
Shijiazhuang, Hebei
Linge Li, +86 13323043660, zyypfk2008@126.com
The Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei
Zhang Yan, +86 18531117076, 1120582978@qq.com
The First Affiliated Hospital of Wannan Medical College (Yijishan)
Wuhu, Anhui
Chao Ci, +86 13956218911, cichao8911@126.com
Wuxi Second People's Hospital
Wuxi, Jiangsu
Hui Sun, +86 15961820697, sunhui19760302@163.com
Henan Provincial People's Hospital
Zhengzhou, Henan
HongWei Liu, +86 18637110289
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 Tablets in Adult Patients With Moderate to Severe Plaque Psoriasis
This study adopted a multicenter, randomized, double-blind, placebo-controlled phase II/III operation seamless adaptive design, aiming to evaluate the efficacy, safety and tolerability of CMS-D001 tablets in the treatment of patients with moderate to severe plaque psoriasis. The trial consists of two parts, including the Phase II clinical research stage and the Phase III clinical research stage.
Read the detailed description
In the Phase II clinical research stage, a multi-center, randomized, double-blind, placebo-controlled design will be adopted, with a planned enrollment of 120 participants. After providing written informed consent and completing all screening evaluations, eligible participants will be randomly assigned in a 1:1:1 ratio to Trial Group 1, Trial Group 2, and the placebo group, with 40 participants in each group.All randomly assigned participants will undergo a 12-week double-blind treatment and continue to be followed up until the 16th week. The study is divided into three phases: the screening period (up to 4 weeks), the treatment period (12 weeks, approximately 85 ± 3 days), and the follow-up period (2 weeks after the last dose).
In the Phase III clinical research stage, a multi-center, randomized, double-blind, placebo-controlled design will be adopted. It is planned to continue enrolling participants in the Phase III study after the completion of the Phase II clinical trial enrollment, based on the Phase II dose groups (or the recommended dose groups determined based on the Phase II study results) and the placebo group. A total of 420 participants are planned to be enrolled. After providing written informed consent and completing all screening evaluations, eligible participants will be randomly assigned in a 2:2:1 ratio to the CMS-D001 tablet 50 mg QD, 100 mg QD, and placebo control groups. Each treatment group will have a maximum of 168 participants (excluding those who switch from the placebo group), and the placebo group will have a maximum of 84 participants.The research was divided into 4 phases, namely the screening phase (up to 4 weeks), the base phase (16 weeks), the expansion phase (36 weeks), and the follow-up phase (4 weeks after the last administration).
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- CMS-D001 50mg, CMS-D001 100mg, 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
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 |
| 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.
Phase Ⅱ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Measured: At week 12
Phase Ⅲ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Measured: At week 16
Phase Ⅲ:Number of participants achieving a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) (PGA-TS)
Measured: At week 16
Secondary outcomes (12)
PhaseⅡ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Measured: At week 2, 4, 8
PhaseⅡ:Number of participants achieving a Physicians Global Assessment (PGA) score of 0 or 1.
Measured: At week 2, 4, 8, 12
PhaseⅡ:Number of participants achieving at least 50%, 90%, or 100% improvement in PASI (PASI 50/90/100)
Measured: At week 2, 4, 8, 12
PhaseⅡ:Change and percentage change from baseline in the Psoriasis Area and Severity Index (PASI) score.
The PASI scale ranges from 0 (minimum) to 72 (maximum), with higher scores indicating more severe psoriasis (worse outcome).
Measured: At week 2, 4, 8, 12
PhaseⅡ:Change and percentage change in affected Body Surface Area (BSA) from baseline
Measured: At week 2, 4, 8, 12
PhaseⅡ:Change in Dermatology Life Quality Index (DLQI) score from baseline
The total score of the Dermatology Life Quality Index (DLQI) questionnaire ranges from 0 (minimum) to 30 (maximum), with higher scores indicating more severe impairment of quality of life.
Measured: At week 2, 4, 8, 12
Phase Ⅲ:Number of participants achieving at least 75% improvement in PASI (PASI 75)
Measured: At weeks 2, 4, 8, 12 and at each visit in the extension period
Phase Ⅲ:Number of participants achieving at least 90% or 100% improvement in PASI (PASI 90/100)
Measured: At weeks 2, 4, 8, 12, 16 and at each visit in the extension period
Phase Ⅲ:Number of participants achieving a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear)
Measured: At weeks 2, 4, 8, 12 and at each visit in the extension period
Phase Ⅲ:Change and percentage change in PASI score from baseline
Measured: At weeks 2, 4, 8, 12, 16 and at each visit in the extension period
Phase Ⅲ:Change and percentage change in affected Body Surface Area (BSA) from baseline
Measured: At weeks 2, 4, 8, 12, 16 and at each visit in the extension period
Phase Ⅲ:Change in Dermatology Life Quality Index (DLQI) score from baseline
The total score of the Dermatology Life Quality Index (DLQI) questionnaire ranges from 0 (minimum) to 30 (maximum), with higher scores indicating more severe impairment of quality of life.
Measured: At weeks 2, 4, 8, 12, 16 and at each visit in the extension period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start3 Mar 2026 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion30 Jul 2028 (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 Plaque PsoriasisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 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
- NCT07432854
- Sponsor's protocol ID
- D001-02-002
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- 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 25 Feb 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/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 Tablets in Adult Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07432854
- Acronym / sponsor ID
- D001-02-002
- Conditions
- Moderate to Severe Plaque Psoriasis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Dermavon Holdings LimitedIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2026 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 25 Feb 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 adopted a multicenter, randomized, double-blind, placebo-controlled phase II/III operation seamless adaptive design, aiming to evaluate the efficacy, safety and tolerability of CMS-D001 tablets in the treatment of patients with moderate to severe plaque psoriasis. The trial consists of two parts, including the Phase II clinical research stage and the Phase III clinical research stage.
Detailed description
In the Phase II clinical research stage, a multi-center, randomized, double-blind, placebo-controlled design will be adopted, with a planned enrollment of 120 participants. After providing written informed consent and completing all screening evaluations, eligible participants will be randomly assigned in a 1:1:1 ratio to Trial Group 1, Trial Group 2, and the placebo group, with 40 participants in each group.All randomly assigned participants will undergo a 12-week double-blind treatment and continue to be followed up until the 16th week. The study is divided into three phases: the screening period (up to 4 weeks), the treatment period (12 weeks, approximately 85 ± 3 days), and the follow-up period (2 weeks after the last dose).
In the Phase III clinical research stage, a multi-center, randomized, double-blind, placebo-controlled design will be adopted. It is planned to continue enrolling participants in the Phase III study after the completion of the Phase II clinical trial enrollment, based on the Phase II dose groups (or the recommended dose groups determined based on the Phase II study results) and the placebo group. A total of 420 participants are planned to be enrolled. After providing written informed consent and completing all screening evaluations, eligible participants will be randomly assigned in a 2:2:1 ratio to the CMS-D001 tablet 50 mg QD, 100 mg QD, and placebo control groups. Each treatment group will have a maximum of 168 participants (excluding those who switch from the placebo group), and the placebo group will have a maximum of 84 participants.The research was divided into 4 phases, namely the screening phase (up to 4 weeks), the base phase (16 weeks), the expansion phase (36 weeks), and the follow-up phase (4 weeks after the last administration).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CMS-D001 50mg | Experimental | Drug: CMS-D001 50mg |
| CMS-D001 100mg | Experimental | Drug: CMS-D001 100mg |
| 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 (4 listed)
- Aged 18-75 years, willing to sign the ICF
- Diagnosed with plaque psoriasis for at least 6 months prior to screening.
- At screening and baseline, PASI score ≥ 12 points, BSA ≥ 10%, sPGA ≥ 3
- Be eligible for phototherapy or systemic therapy.
Key exclusion criteria (12 listed)
- Non-plaque psoriasis (ie, guttate, pustular, erythrodermic, or inverse psoriasis) within 3 months prior to baseline.
- Other skin diseases at screening or baseline Drug-induced psoriasis.
- History of severe herpes zoster or severe herpes simplex or current herpes simplex/zoster infection.
- 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.
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 |
| PlaceboPlacebo QD | Drug | Placebo |
Primary outcome
Phase Ⅱ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Time frame: At week 12
Phase Ⅲ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Time frame: At week 16
Phase Ⅲ:Number of participants achieving a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) (PGA-TS)
Time frame: At week 16
12 secondary outcomes
PhaseⅡ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Time frame: At week 2, 4, 8
PhaseⅡ:Number of participants achieving a Physicians Global Assessment (PGA) score of 0 or 1.
Time frame: At week 2, 4, 8, 12
PhaseⅡ:Number of participants achieving at least 50%, 90%, or 100% improvement in PASI (PASI 50/90/100)
Time frame: At week 2, 4, 8, 12
PhaseⅡ:Change and percentage change from baseline in the Psoriasis Area and Severity Index (PASI) score.
Time frame: At week 2, 4, 8, 12
PhaseⅡ:Change and percentage change in affected Body Surface Area (BSA) from baseline
Time frame: At week 2, 4, 8, 12
PhaseⅡ:Change in Dermatology Life Quality Index (DLQI) score from baseline
Time frame: At week 2, 4, 8, 12
Phase Ⅲ:Number of participants achieving at least 75% improvement in PASI (PASI 75)
Time frame: At weeks 2, 4, 8, 12 and at each visit in the extension period
Phase Ⅲ:Number of participants achieving at least 90% or 100% improvement in PASI (PASI 90/100)
Time frame: At weeks 2, 4, 8, 12, 16 and at each visit in the extension period
Phase Ⅲ:Number of participants achieving a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear)
Time frame: At weeks 2, 4, 8, 12 and at each visit in the extension period
Phase Ⅲ:Change and percentage change in PASI score from baseline
Time frame: At weeks 2, 4, 8, 12, 16 and at each visit in the extension period
Phase Ⅲ:Change and percentage change in affected Body Surface Area (BSA) from baseline
Time frame: At weeks 2, 4, 8, 12, 16 and at each visit in the extension period
Phase Ⅲ:Change in Dermatology Life Quality Index (DLQI) score from baseline
Time frame: At weeks 2, 4, 8, 12, 16 and at each visit in the extension period
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 25 Feb 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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CMS-D001 50mg and CMS-D001 100mg in people with Moderate to Severe Plaque Psoriasis, run by Dermavon Holdings Limited at 21 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 4 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 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact FuRen Zhang (+86 13608921718, zhangfuren@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ⅱ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) (time frame: At week 12). The study lists 3 primary outcomes in all. 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 25 Feb 2026.