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

Haisco Pharmaceutical Group

Status and phase: Not yet enrolling; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: HSK47388

Study type: Interventional

Funder types: Industry

Identifiers

NCT07158268

HSK47388-201

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 4 patient groups, including a placebo group

HSK47388 matching placebo will be administered orally.

Placebo Comparator group

Treatment:

Drug: HSK47388

HSK47388 dose 1 will be administered orally.

Experimental group

Treatment:

Drug: HSK47388

HSK47388 dose 2 will be administered orally.

Experimental group

Treatment:

Drug: HSK47388

HSK47388 dose 3 will be administered orally.

Experimental group

Treatment:

Drug: HSK47388