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NCT Number: NCT06926582

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

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

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, 200443, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

HS-10374 6mg tablets

Drug

Administered orally QD for 12 weeks

HS-10374-matched placebo tablets

Drug

Administered orally QD for 12 weeks

Primary outcomes

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

    Time frame: Baseline to 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.

Secondary outcomes

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

    Time frame: Baseline to Week 16

  2. Number of participants with clinical laboratory abnormalities

    Time frame: Baseline to Week 16

    Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, C-reactive protein, etc.

  3. Incidence of clinically significant changes in electrocardiogram (ECG)

    Time frame: Baseline to Week 16

    ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.

  4. Number of participants with abnormalities of physical examination

    Time frame: Baseline to Week 16

    Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.

  5. Number of participants with abnormalities of vital signs

    Time frame: Baseline to Week 16

    Vital signs measured include blood pressure, pulse rate, and temperature.

  6. Proportion of patients with sPGA 0/1 at specified time points

    Time frame: Baseline to 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.

  7. Proportion of patients achieving BSA 75 response at specified time points

    Time frame: Baseline to Week 16

    Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved. BSA 75 response is defined as 75% or greater improvement in BSA score from baseline.

  8. Change from baseline in BSA at specified time points

    Time frame: Baseline to Week 16

    Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.

  9. Proportion of patients who achieved BSA ≤ 1% at specified time points

    Time frame: Baseline to Week 16

    Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.

  10. Change from baseline in PASI at specified time points

    Time frame: Baseline to 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.

  11. Proportion of patients who achieved BSA ≤ 3% for patients with baseline BSA > 3% at specified time points

    Time frame: Baseline to Week 16

    Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.

  12. Proportion of patients achieving ss-PGA 0/1 for patients with a baseline ss-PGA score ≥2 at specified time points

    Time frame: Baseline to Week 16

    Scalp specific physician's global assessment (sPGA) of psoriasis is an assessment of the disease severity of scalp psoriasis based on erythema, thickness, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "absence of disease" or "very mild disease" respectively.

  13. Change from baseline in DLQI scores at specified time points

    Time frame: Baseline to Week 16

    The dermatology life quality index (DLQI) is a patient reported outcome measurement. It's a questionnaire consisting of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. Each question is scored on a scale of 0 to 3, and the sum of each scores range from 0 (no impairment of life quality) to 30 (maximum impairment).

Study contacts

Contact information is provided by the study sponsor or research team.

Yuling Shi, MD

CONTACT

[email protected]

(0086)021-61833000

Sponsors and collaborators

Lead sponsor

Hansoh BioMedical R&D Company

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2025
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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