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A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis | Clinical Trials | Clareo Health

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A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate Clinical Efficacy and Safety of HS-10374 in Adult Patients With Mild-to-moderate Plaque Psoriasis

NCT06926582•Hansoh BioMedical R&D Company

View on ClinicalTrials.gov

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 a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:2:1 ratio to receive HS-10374 Dose 1, HS-10374 Dose 2, or placebo.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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. sPGA score of 2-3, BSA 2-15%, PASI score 2-15
•4. Subject must be inadequately controlled with, or intolerant of at least one topical therapy

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. Prior exposure to TYK2 inhibitors
•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

Locations (1)

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 9, 2025

Primary Completion Date

July 9, 2026

Completion Date

December 9, 2026

Last Updated

April 13, 2025

Enrollment

305

ESTIMATED participants

Conditions

Psoriasis

Interventions

HS-10374 6mg tablets

DRUG

HS-10374-matched placebo tablets

DRUG

Contacts

Yuling Shi, MD

CONTACT

(0086)021-61833000 shiyuling1973@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

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