HS-10374 6mg tablets: Specified dose of HS-10374 tablets administered orally QD on specified days
HS-10374-matched placebo tablets: Specified dose of HS-10374-matched placebo tablets administered orally QD on specified days
Study summary
This study has been designed to confirm the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Male or female subjects aged 18 years and older
* Diagnosis of plaque psoriasis for at least 6 months
* Eligible for phototherapy or systemic therapy
* Plaque covering ≥ 10% of BSA
* PASI ≥ 12, sPGA ≥3
Exclusion Criteria:
* Diagnosis of non-plaque psoriasis or drug-induced psoriasis
* Recent history of infection, history or risk of serious infection
* Any major illness or evidence of unstable condition of major organ systems including psychiatric disease
* Any condition possibly affecting the PK process of the study drug
* Evidence of other skin conditions that would interfere with the evaluation of psoriasis
* History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis
* Prior exposure to TYK2 inhibitors
* Have received the prohibited treatment during the protocol required washout period
* Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period
Primary outcome measure(s)
Proportion of patients achieving PASI 75 response at Week 16 — Baseline to Week 16 Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 response is defined as 75% or greater improvement in PASI score from baseline.
Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 16 — Baseline to Week 16 Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively.
Trial sites (1)
Facility
City
Region
Status
Huashan Hospital affiliated to Fudan University
Shanghai
Shanghai Municipality
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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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