Status:
NOT_YET_RECRUITING
A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis
Lead Sponsor:
Hansoh BioMedical R&D Company
Conditions:
Psoriasis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of mild-to-moderate plaque psoriasis.
Detailed Description
This is a 12-week, multi-center, randomized, double-blind, placebo-controlled, Phase II study. The study duration includes a 4-week screening period, a 12-week placebo-controlled treatment period, and...
Eligibility Criteria
Inclusion
- Male or female subjects between the ages of 18-70 years
- Diagnosis of plaque psoriasis for at least 6 months
- sPGA score of 2-3, BSA 2-15%, PASI score 2-15
- Subject must be inadequately controlled with, or intolerant of at least one topical therapy
Exclusion
- 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
Key Trial Info
Start Date :
April 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 9 2026
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT06926582
Start Date
April 9 2025
End Date
December 9 2026
Last Update
April 13 2025
Active Locations (1)
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1
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China, 200443