A Phase 2 Study of HSK47388 Tablets to Evaluate the Efficacy and Safety in Patients With Moderate-to-Severe Plaque Psoriasis

Phase 2Not Yet RecruitingNCT07158268

Haisco Pharmaceutical Group Co., Ltd.220 enrolled

Overview

The primary objective of this study is to evaluate the efficacy of multiple-dose HSK47388 versus placebo in participants with moderate-to-severe plaque psoriasis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

220

Conditions

Plaque Psoriasis

Interventions

HSK47388DRUG

HSK47388 tablets will be administered orally, once a day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Confirmed diagnosis of plaque psoriasis with a disease duration of at least 26 weeks before the first administration of the study intervention 2. Total Body Surface Area (BSA) involvement ≥ 10% at both screening and baseline visits 3. Psoriasis Area and Severity Index (PASI) total score ≥ 12 at both screening and baseline visits 4. Investigator Global Assessment (IGA) for plaque psoriasis total score ≥ 3 (moderate or severe disease) at both screening and baseline visits 5. Participants deemed appropriate candidates for systemic therapy for plaque psoriasis Exclusion Criteria: 1. Non-plaque psoriasis (e.g., erythrodermic, guttate, or pustular psoriasis) 2. Current drug-induced psoriasis 3. Current diagnosis, signs, or symptoms of severe, progressive, or uncontrolled disease involving the renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic systems 4. Known allergy, hypersensitivity, or intolerance to HSK47388。 5. A history of malignant tumor before screening; 6. Subjects deemed unsuitable for participation due to other factors as determined by the investigator

Outcomes

Primary Outcomes

HSK47388 and Placebo Group: Percentage of Participants Achieving PASI 75 Response From Baseline to week 16

Percentage of participants achieving PASI 75 response (\>=75% improvement in PASI from baseline) at Week 16 will be reported. The PASI is a system for assessing/grading psoriatic lesion severity and treatment response. It divides the body into 4 regions (head, trunk, upper extremities, lower extremities), with each region separately scored for erythema, induration, scaling (0-4 scale each) and involvement extent (0-6 scale). PASI yields a 0-72 numeric score, where higher scores mean more severe disease.

Time frame: 16 weeks

Secondary Outcomes

HSK47388 and placebo Group: Percentage of Participants Achieving an IGA Score of 0 or 1 and >=2 Grade Improvement From Baseline at Weeks 16

The percentage of participants with IGA 0/1 and ≥2-grade improvement from baseline at Weeks 16 will be reported. IGA is investigators' assessment of participants' psoriasis at a specific time point, grading overall lesions by induration, erythema, scaling, and categorizing psoriasis as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Time frame: 16 weeks

Change From Baseline in Body Surface Area (BSA) at Week 16

Change from baseline in BSA at Week 16 will be reported. BSA is a common measure of skin disease extent, defined as the percentage of total body surface area affected by the target condition (i.e., plaque psoriasis).

Time frame: 16 weeks

HSK47388 and Placebo Group: Change From Baseline in Total DLQI Score at Week 16

Change from baseline in total DLQI score at Week 16 will be reported. The DLQI is a dermatology-specific HRQoL instrument designed to assess a disease's impact on participants' HRQoL. It is a 10-item questionnaire evaluating HRQoL over the past week; in addition to overall HRQoL, it assesses 6 quality-of-life domains: symptoms/feelings, daily activities, leisure, work/school performance, personal relationships, and treatment. Total scores range from 0 to 30, with higher scores indicating greater HRQoL impact.

Data from ClinicalTrials.gov

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