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
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)
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
Trial sites (21)
Facility
City
Region
Status
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
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.
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