About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CMS-D001 50mg
- CMS-D001 100mg
- Placebo