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Clinical Trials in China / NCT07432854
Starting soon Phase 2/3

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

NCT07432854 · tracked via the Priya Life Science China tracker
Sponsor
Dermavon Holdings Limited
Phase
Phase 2/3
Started
2026-03-03
Last updated
2026-02-25

Condition(s) studied

Moderate to Severe Plaque Psoriasis

Investigational drug(s) / intervention(s)

CMS-D001 50mgCMS-D001 100mgPlacebo

CMS-D001 50mg: CMS-D001 50mg QD

CMS-D001 100mg: CMS-D001 100mg QD

Placebo: Placebo QD

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui
The First Affiliated Hospital of Wannan Medical College (Yijishan) Wuhu Anhui
Southern Medical University Dermatology Hospital Guangzhou Guangdong
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong
Affiliated Hospital of Chengde Medical College Chengde Hebei
Affiliated Hospital of Hebei University of Engineering Handan Hebei
Shijiazhuang Traditional Chinese Medicine Hospital Shijiazhuang Hebei
The Fourth Affiliated Hospital of Hebei Medical University Shijiazhuang Hebei
The Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
Nanyang Central Hospital Nanyang Henan
Sanmenxia Central Hospital Sanmenxia Henan
Henan Provincial People's Hospital Zhengzhou Henan
Wuxi Second People's Hospital Wuxi Jiangsu
The First Hospital of Jilin University Changchun Jilin
Jining First People's Hospital Jining Shandong
Shandong First Medical University Affiliated Dermatology Hospital Jinan Shangdong
Hangzhou First People's Hospital Hangzhou Zhejiang
Hangzhou Third People's Hospital Hangzhou Zhejiang
Zhejiang Provincial People's Hospital Hangzhou Zhejiang
Beijing Tongren Hospital Affiliated to Capital Medical University Beijing China
Shanghai Dermatology Hospital Shanghai China

More Dermavon Holdings Limited trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07432854 on ClinicalTrials.gov ↗ ← All trials in China