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HSK47388 for Moderate to Severe Plaque Psoriasis

Study Aim

This study aims to evaluate the effectiveness and safety of the drug HSK47388 in adults with moderate to severe plaque psoriasis.

What is being tested

HSK47388

Drug

Who is being recruted

Over 18 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: September 2025

See protocol details

Summary

Principal SponsorHaisco Pharmaceutical Group Co., Ltd.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on evaluating the effectiveness and safety of a new treatment called HSK47388 for individuals suffering from moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches, and this research aims to find out if HSK47388 can help reduce these symptoms. This study is crucial because finding effective treatments can significantly improve the quality of life for people dealing with this chronic skin condition. Participants in this study receive either the HSK47388 treatment or a placebo, which is a substance with no active medication, to compare the results. The treatment is given in multiple doses, though the method of administration isn't specified. The study carefully monitors the results to determine how well the treatment works and to ensure it is safe for participants. By comparing the outcomes between the group receiving the actual treatment and the placebo group, researchers aim to gather clear evidence about the benefits and risks of HSK47388.

Official TitleA 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

Principal SponsorHaisco Pharmaceutical Group Co., Ltd.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

220 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate

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

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6 exclusion criteria prevent from participating

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。

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

Recruiting soonNo study centers