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

Starting soon · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Moderate to Severe Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT07432854

Run by

Dermavon Holdings Limited

People needed

540

Starts

2026-03-03

Expected to finish

2028-07-30

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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