A Study to Confirm Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis

NCT06672393 | Not Yet Recruiting Phase 3

• 1 other identifier: HS-10374-301
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

This study has been designed to confirm the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• Proportion of patients achieving PASI 75 response at Week 16

  Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 response is defined as 75% or greater improvement in PASI score from baseline.

  Baseline to Week 16

• Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 16

  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 16

Secondary Outcomes (15)

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

  Baseline to Week 56

• Number of participants with clinical laboratory abnormalities

  Baseline to Week 56

• Incidence of clinically significant changes in electrocardiogram (ECG)

  Baseline to Week 56

• Number of participants with abnormalities of physical examination

  Baseline to Week 56

• Number of participants with abnormalities of vital signs

  Baseline to Week 56

Study Arms (2)

HS-10374

EXPERIMENTAL

Subjects will receive HS-10374 from Week 0 through Week 52.

Drug: HS-10374 6mg tablets

Placebo

PLACEBO COMPARATOR

Subjects will receive HS-10374 matching placebo from Week 0 through Week 16, and HS-10374 from Week 16 through Week 52.

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

Interventions

HS-10374 6mg tablets DRUG

Specified dose of HS-10374 tablets administered orally QD on specified days

HS-10374; Placebo

HS-10374-matched placebo tablets DRUG

Specified dose of HS-10374-matched placebo tablets administered orally QD on specified days

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female subjects aged 18 years and older
• Diagnosis of plaque psoriasis for at least 6 months
• Eligible for phototherapy or systemic therapy
• Plaque covering ≥ 10% of BSA
• PASI ≥ 12, sPGA ≥3

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)

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jinhua Xu, MD

CONTACT

(+86)13818978539; xjhhsyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: November 4, 2024
• Primary Completion: October 22, 2025
• Study Completion (Estimated): June 29, 2026
• Last Updated: November 4, 2024

Record last verified: 2024-10

Locations

CN (1)