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

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.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Confirmed diagnosis of plaque psoriasis with a disease duration of at least 26 weeks before the first administration of the study intervention
Total Body Surface Area (BSA) involvement ≥ 10% at both screening and baseline visits
Psoriasis Area and Severity Index (PASI) total score ≥ 12 at both screening and baseline visits
Investigator Global Assessment (IGA) for plaque psoriasis total score ≥ 3 (moderate or severe disease) at both screening and baseline visits
Participants deemed appropriate candidates for systemic therapy for plaque psoriasis

Exclusion criteria

Non-plaque psoriasis (e.g., erythrodermic, guttate, or pustular psoriasis)
Current drug-induced psoriasis
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
Known allergy, hypersensitivity, or intolerance to HSK47388。
A history of malignant tumor before screening;
Subjects deemed unsuitable for participation due to other factors as determined by the investigator

Treatment and study plan

HSK47388

Drug

HSK47388 tablets will be administered orally, once a day

Primary outcomes

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

Time frame: 16 weeks

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.

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

Time frame: 16 weeks

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

Time frame: 16 weeks

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

Time frame: 16 weeks

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.
Number of Participants with Adverse Events (AEs)

Time frame: 20 weeks

An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

A Phase 2 Multicenter, Randomized, Double-blind and Two-Stage Study to Evaluate the Efficacy and Safety of HSK47388 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Sep 5, 2025
Registry last updated: Sep 5, 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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