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

NCT ID: NCT06926582

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 305 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-09
• Study Completion Date: 2026-12-09

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 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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HS-10374 Dose 1

Group Type: EXPERIMENTAL

HS-10374 6mg tablets

Intervention Type: DRUG

Administered orally QD for 12 weeks

HS-10374-matched placebo tablets

Intervention Type: DRUG

Administered orally QD for 12 weeks

HS-10374 Dose 2

Group Type: EXPERIMENTAL

HS-10374 6mg tablets

Intervention Type: DRUG

Administered orally QD for 12 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

HS-10374-matched placebo tablets

Intervention Type: DRUG

Administered orally QD for 12 weeks

Interventions

HS-10374 6mg tablets

Administered orally QD for 12 weeks

Intervention Type: DRUG

HS-10374-matched placebo tablets

Administered orally QD for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hansoh BioMedical R&D Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuling Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Dermatology Hospital

Locations

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Yuling Shi, MD

Role: CONTACT

shiyuling1973@126.com

(0086)021-61833000

Other Identifiers

HS-10374-205

Identifier Type: -

Identifier Source: org_study_id