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NCT Number: NCT06672393

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

About this study

This is a 52-week, multi-center, randomized, double-blind, placebo-controlled, Phase 3 study. The study duration includes a 4-week screening period, a 16-week placebo-controlled treatment period, a 36-week study drug treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:1 ratio to receive HS-10374 or placebo QD. At Week 16, subjects receiving placebo will be switched to HS-10374 QD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

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

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

HS-10374-matched placebo tablets

Drug

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

Primary outcomes

  1. Proportion of patients achieving PASI 75 response at Week 16

    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. PASI 75 response is defined as 75% or greater improvement in PASI score from baseline.

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

    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.

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 56

  2. Number of participants with clinical laboratory abnormalities

    Time frame: Baseline to Week 56

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

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

    Time frame: Baseline to Week 56

    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 56

    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 56

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

  6. PASI 75 response rates at specified time points

    Time frame: Baseline to Week 56

    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.

  7. PASI 90 response rates at specified time points

    Time frame: Baseline to Week 56

    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 90 response is defined as 90% or greater improvement in PASI score from baseline.

  8. PASI 100 response rates at specified time points

    Time frame: Baseline to Week 56

    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 100 response is defined as 100% improvement in PASI score from baseline.

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

    Time frame: Baseline to Week 56

    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.

  10. Proportion of patients with sPGA 0 at specified time points

    Time frame: Baseline to Week 56

    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 means "clear".

  11. Proportion of patients achieving PSSD symptom score of 0 at specified time points among patients with a baseline symptom score ≥1

    Time frame: Baseline to Week 56

    Psoriasis symptoms and signs diary (PSSD) is an 11-item patient-reported instrument. It assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 subject-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated from 0 (absent) to 10 (worst imaginable). Two subscores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.

  12. Proportion of patients achieving DLQI 0/1 at specified time points among patients with a baseline DLQI score ≥2

    Time frame: Baseline to Week 56

    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).

  13. Proportion of patients achieving ss-PGA 0/1 at Week 16 among patients with a baseline ss-PGA score ≥3

    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.

  14. Proportion of patients achieving PGA-F 0/1 at Week 16 among patients with a baseline PGA-F score ≥3

    Time frame: Baseline to Week 16

    Physician's global assessment of fingernails (PGA-F) is a scale used to assess a patient's fingernail psoriasis. Ten fingernails on the hand will be globally evaluated separately for nail bed and nail matrix disease on a scale of 0 to 4. The overall global assessment of nails is the worse of the nail bed and nail matrix assessment. A PGA-F score of 0 or 1 means "clear" or "minimal" respectively.

  15. Proportion of patients achieving pp-PGA 0/1 at Week 16 among patients with a baseline pp-PGA score ≥3

    Time frame: Baseline to Week 16

    Palmoplantar PGA (pp-PGA) is a scale performed by investigators to assess a patient's palmoplantar psoriasis lesions on a scale of 0 to 4. A pp-PGA score of 0 or 1 means "clear" or "almost clear" respectively.

Study contacts

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

Jinhua Xu, MD

CONTACT

[email protected]

(+86)13818978539

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 3 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 4, 2024
Registry last updated
Nov 4, 2024

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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