A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis

HS-10374-201

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.

2023-09-28

2024-07-31

2024-08-31

Recruiting

Early phase I

120

Inclusion Criteria: 1. Male or female subjects between the ages of 18-70 years 2. Diagnosis of plaque psoriasis for at least 6 months 3. Eligible for phototherapy or systemic therapy 4. Plaque covering ≥ 10% of BSA 5. PASI ≥ 12, sPGA ≥3 Exclusion Criteria: 1. Diagnosis of non-plaque psoriasis or drug-induced psoriasis 2. Recent history of infection, history or risk of serious infection 3. Any major illness or evidence of unstable condition of major organ systems including psychiatric disease 4. Any condition possibly affecting the PK process of the study drug 5. Evidence of other skin conditions that would interfere with the evaluation of psoriasis 6. History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis 7. 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 8. Have received the prohibited treatment during the protocol required washout period 9. Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2023-12-06