NCT07432854Not yet recruitingPhase 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
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
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 540 (estimated)
- First submitted
- 13 Feb 2026
- Start date
- 3 Mar 2026
- Primary completion date
- 29 Feb 2028
- Lead sponsor
- Dermavon Holdings Limited
- Diseases
- Psoriasis
- NCT number
- NCT07432854
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 540
- From 3 Mar 2026 to the primary completion date, 29 Feb 2028
- 21 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Non-plaque psoriasis (ie, guttate, pustular, erythrodermic, or inverse psoriasis) within 3 months prior to baseline.
- 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.
- History of a major or unstable clinical condition within 6 months prior to the first dose, which would compromise participation.
- Previous or current autoimmune diseases.
- Allergic to any component of the investigational drug.
Other illness
- 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.
- 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 malignant tumour within 5 years before screening.
- Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tongren Hospital affiliated to Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital of Bengbu Medical College Coordinator of this site? Confirm its status | Bengbu | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Affiliated Hospital of Chengde Medical College Coordinator of this site? Confirm its status | Chengde | China | Unknown status |
| Southern Medical University Dermatology Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhujiang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Affiliated Hospital of Hebei University of Engineering Coordinator of this site? Confirm its status | Handan | China | Unknown status |
| Hangzhou First People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Hangzhou Third People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Second Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Shandong First Medical University Affiliated Dermatology Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jining First People's Hospital Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| Nanyang Central Hospital Coordinator of this site? Confirm its status | Nanyang | China | Unknown status |
| Sanmenxia Central Hospital Coordinator of this site? Confirm its status | Sanmenxia | China | Unknown status |
| Shanghai Dermatology Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The Fourth Affiliated Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Shijiazhuang Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| The First Affiliated Hospital of Wannan Medical College (Yijishan) Coordinator of this site? Confirm its status | Wuhu | China | Unknown status |
| Wuxi Second People's Hospital Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| Henan Provincial People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.