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

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

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

NCT07158268•Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

September 1, 2025

Primary Completion Date

December 20, 2026

Completion Date

January 17, 2027

Last Updated

September 5, 2025

Enrollment

220

ESTIMATED participants

Conditions

Plaque Psoriasis

Interventions

HSK47388

DRUG

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Plaque Psoriasis

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RECRUITINGPHASE2

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

NCT07449702

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis