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

NCT ID: NCT07158268

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-01-17

Brief 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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HSK47388 matching placebo will be administered orally.

Group Type: PLACEBO_COMPARATOR

HSK47388

Intervention Type: DRUG

HSK47388 tablets will be administered orally, once a day

HSK47388 dose 1 will be administered orally.

Group Type: EXPERIMENTAL

HSK47388

Intervention Type: DRUG

HSK47388 tablets will be administered orally, once a day

HSK47388 dose 2 will be administered orally.

Group Type: EXPERIMENTAL

HSK47388

Intervention Type: DRUG

HSK47388 tablets will be administered orally, once a day

HSK47388 dose 3 will be administered orally.

Group Type: EXPERIMENTAL

HSK47388

Intervention Type: DRUG

HSK47388 tablets will be administered orally, once a day

Interventions

HSK47388

HSK47388 tablets will be administered orally, once a day

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HSK47388-201

Identifier Type: -

Identifier Source: org_study_id