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 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
1 other identifier
interventional
540
1 country
21
Brief 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. The trial consists of two parts, including the Phase II clinical research stage and the Phase III clinical research stage.
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
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2026
CompletedFirst Posted
Study publicly available on registry
February 25, 2026
CompletedStudy Start
First participant enrolled
March 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2028
February 25, 2026
February 1, 2026
2 years
February 13, 2026
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Phase Ⅱ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
At week 12
Phase Ⅲ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
At week 16
Phase Ⅲ:Number of participants achieving a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) (PGA-TS)
At week 16
Secondary Outcomes (12)
PhaseⅡ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
At week 2, 4, 8
PhaseⅡ:Number of participants achieving a Physicians Global Assessment (PGA) score of 0 or 1.
At week 2, 4, 8, 12
PhaseⅡ:Number of participants achieving at least 50%, 90%, or 100% improvement in PASI (PASI 50/90/100)
At week 2, 4, 8, 12
PhaseⅡ:Change and percentage change from baseline in the Psoriasis Area and Severity Index (PASI) score.
At week 2, 4, 8, 12
PhaseⅡ:Change and percentage change in affected Body Surface Area (BSA) from baseline
At week 2, 4, 8, 12
- +7 more secondary outcomes
Other Outcomes (2)
PhaseⅡ:Incidence of adverse events (AEs) changes in routine safety parameters
through study completion, an average of 133 days
Phase Ⅲ:Incidence of adverse events (AEs) changes in routine safety parameters
through study completion, an average of 393 days
Study Arms (3)
CMS-D001 50mg
EXPERIMENTALCMS-D001 100mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The First Affiliated Hospital of Wannan Medical College (Yijishan)
Wuhu, Anhui, China
Southern Medical University Dermatology Hospital
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Affiliated Hospital of Chengde Medical College
Chengde, Hebei, China
Affiliated Hospital of Hebei University of Engineering
Handan, Hebei, China
Shijiazhuang Traditional Chinese Medicine Hospital
Shijiazhuang, Hebei, China
The Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Nanyang Central Hospital
Nanyang, Henan, China
Sanmenxia Central Hospital
Sanmenxia, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Wuxi Second People's Hospital
Wuxi, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Jining First People's Hospital
Jining, Shandong, China
Shandong First Medical University Affiliated Dermatology Hospital
Jinan, Shangdong, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, China
Shanghai Dermatology Hospital
Shanghai, China
Central Study Contacts
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
February 13, 2026
First Posted
February 25, 2026
Study Start
March 3, 2026
Primary Completion (Estimated)
February 29, 2028
Study Completion (Estimated)
July 30, 2028
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share