Overview
This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis. Additionally, this study is to find the optimal dosing for the future clinical development of HS-10374.
Description
This is a 12-week, multi-center, randomized, double blind, placebo-controlled, Phase 2 study. The study duration includes a 4-week screening period, a 12-week treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned to 1 of 3 treatment arms (HS-10374 Dose 1, HS-10374 Dose 2, and placebo) in an equal ratio.
Eligibility
Inclusion Criteria:
- Male or female subjects between the ages of 18-70 years
- 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
- History of lack of response to any therapeutic agent targeted to IL-12, IL-17 or IL-23 at approved doses after at least 3 months of therapy
- 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