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

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• Psoriasis 1,899

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's planned enrollment of 375 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Lead sponsor

Hansoh BioMedical R&D Company is the lead sponsor of 44 studies on the registry; 41 are open to participants now.

Study arms

• Experimental
  HS-10374

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

  Drug: HS-10374 6mg tablets

• Placebo comparator
  Placebo

  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

• DrugHS-10374 6mg tablets

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

• DrugHS-10374-matched placebo tablets

  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

   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.

   Time frame: Baseline to Week 16

2. 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.

   Time frame: Baseline to Week 16

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

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

   Time frame: Baseline to Week 56

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

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

   Time frame: Baseline to Week 56

4. Number of participants with abnormalities of physical examination

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

   Time frame: Baseline to Week 56

5. Number of participants with abnormalities of vital signs

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

   Time frame: Baseline to Week 56

6. PASI 75 response rates at specified time points

   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.

   Time frame: Baseline to Week 56

7. PASI 90 response rates at specified time points

   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.

   Time frame: Baseline to Week 56

8. PASI 100 response rates at specified time points

   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.

   Time frame: Baseline to Week 56

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

   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.

   Time frame: Baseline to Week 56

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

    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".

    Time frame: Baseline to Week 56

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

    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.

    Time frame: Baseline to Week 56

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

    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).

    Time frame: Baseline to Week 56

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

    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.

    Time frame: Baseline to Week 16

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

    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.

    Time frame: Baseline to Week 16

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

    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.

    Time frame: Baseline to Week 16