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

NCT06926582 | Not Yet Recruiting Phase 2

• 1 other identifier: HS-10374-205
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 12

  Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively.

  Baseline to Week 12

Secondary Outcomes (13)

• Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation

  Baseline to Week 16

• Number of participants with clinical laboratory abnormalities

  Baseline to Week 16

• Incidence of clinically significant changes in electrocardiogram (ECG)

  Baseline to Week 16

• Number of participants with abnormalities of physical examination

  Baseline to Week 16

• Number of participants with abnormalities of vital signs

  Baseline to Week 16

Study Arms (3)

HS-10374 Dose 1

EXPERIMENTAL

Drug: HS-10374 6mg tablets; Drug: HS-10374-matched placebo tablets

HS-10374 Dose 2

EXPERIMENTAL

Drug: HS-10374 6mg tablets

Placebo

PLACEBO COMPARATOR

Drug: HS-10374-matched placebo tablets

Interventions

HS-10374 6mg tablets DRUG

Administered orally QD for 12 weeks

HS-10374 Dose 1; HS-10374 Dose 2

HS-10374-matched placebo tablets DRUG

Administered orally QD for 12 weeks

HS-10374 Dose 1; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, 200443, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yuling Shi, MD

  Shanghai Dermatology Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuling Shi, MD

CONTACT

(0086)021-61833000; shiyuling1973@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 13, 2025
• Study Start: April 9, 2025
• Primary Completion (Estimated): July 9, 2026
• Study Completion (Estimated): December 9, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

CN (1)