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.
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.
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.
Parallel
CMS-D001 50mg
DrugCMS-D001 50mg QD
CMS-D001 100mg
DrugCMS-D001 100mg QD
Placebo
DrugPlacebo QD
Phase Ⅱ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Phase Ⅲ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Phase Ⅲ:Number of participants achieving a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) (PGA-TS)
PhaseⅡ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
PhaseⅡ:Number of participants achieving a Physicians Global Assessment (PGA) score of 0 or 1.
PhaseⅡ:Number of participants achieving at least 50%, 90%, or 100% improvement in PASI (PASI 50/90/100)
PhaseⅡ:Change and percentage change from baseline in the Psoriasis Area and Severity Index (PASI) score.
The PASI scale ranges from 0 (minimum) to 72 (maximum), with higher scores indicating more severe psoriasis (worse outcome).
PhaseⅡ:Incidence of adverse events (AEs) changes in routine safety parameters
Phase Ⅲ:Incidence of adverse events (AEs) changes in routine safety parameters
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This trial is not recruiting at the moment. You can still explore other options:
