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

February 24, 2026 updated by: Dermavon Holdings Limited

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

540

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

  • China
      • Beijing, China
        • Beijing Tongren Hospital Affiliated to Capital Medical University
        • Contact:
      • Shanghai, China
        • Shanghai Dermatology Hospital
        • Contact:
    • Anhui
      • Bengbu, Anhui, China
        • The First Affiliated Hospital Of Bengbu Medical College
        • Contact:
      • Wuhu, Anhui, China
        • The First Affiliated Hospital of Wannan Medical College (Yijishan)
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • ZhuJiang Hospital of Southern Medical University
        • Contact:
      • Guangzhou, Guangdong, China
        • Southern Medical University Dermatology Hospital
        • Contact:
    • Hebei
      • Chengde, Hebei, China
        • Affiliated Hospital of Chengde Medical College
        • Contact:
      • Handan, Hebei, China
        • Affiliated Hospital of Hebei University of Engineering
        • Contact:
      • Shijiazhuang, Hebei, China
        • The Fourth Affiliated Hospital of Hebei Medical University
        • Contact:
      • Shijiazhuang, Hebei, China
        • Shijiazhuang Traditional Chinese Medicine Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
    • Henan
      • Nanyang, Henan, China
        • Nanyang Central Hospital
        • Contact:
      • Sanmenxia, Henan, China
        • Sanmenxia Central Hospital
        • Contact:
      • Zhengzhou, Henan, China
        • Henan Provincial People's Hospital
        • Contact:
          • HongWei Liu
          • Phone Number: +86 18637110289
    • Jiangsu
      • Wuxi, Jiangsu, China
    • Jilin
      • Changchun, Jilin, China
        • The First Hospital of Jilin University
        • Contact:
    • Shandong
      • Jining, Shandong, China
        • Jining First People's Hospital
        • Contact:
    • Shangdong
      • Jinan, Shangdong, China
        • Shandong First Medical University Affiliated Dermatology Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Provincial People's Hospital
        • Contact:
      • Hangzhou, Zhejiang, China
        • Hangzhou First People's Hospital
        • Contact:
      • Hangzhou, Zhejiang, China
        • Hangzhou Third People's Hospital
        • Contact:

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
  • 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.

Exclusion Criteria:

  • 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.
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase Ⅱ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Time Frame: At week 12
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
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
At week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PhaseⅡ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Time Frame: At week 2, 4, 8
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
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
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
The PASI scale ranges from 0 (minimum) to 72 (maximum), with higher scores indicating more severe psoriasis (worse outcome).
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
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
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.
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
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
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
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
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
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
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.
At weeks 2, 4, 8, 12, 16 and at each visit in the extension period

Other Outcome Measures

Outcome Measure
Time Frame
PhaseⅡ:Incidence of adverse events (AEs) changes in routine safety parameters
Time Frame: through study completion, an average of 133 days
through study completion, an average of 133 days
Phase Ⅲ:Incidence of adverse events (AEs) changes in routine safety parameters
Time Frame: through study completion, an average of 393 days
through study completion, an average of 393 days

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 3, 2026

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

July 30, 2028

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • D001-02-002

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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