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

NCT07158268 | Not Yet Recruiting Phase 2

• 1 other identifier: HSK47388-201
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  16 weeks

Secondary Outcomes (4)

• HSK47388 and placebo Group: Percentage of Participants Achieving an IGA Score of 0 or 1 and >=2 Grade Improvement From Baseline at Weeks 16

  16 weeks

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

  16 weeks

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

  16 weeks

• Number of Participants with Adverse Events (AEs)

  20 weeks

Study Arms (4)

HSK47388 matching placebo will be administered orally.

PLACEBO COMPARATOR

Drug: HSK47388

HSK47388 dose 1 will be administered orally.

EXPERIMENTAL

Drug: HSK47388

HSK47388 dose 2 will be administered orally.

EXPERIMENTAL

Drug: HSK47388

HSK47388 dose 3 will be administered orally.

EXPERIMENTAL

Drug: HSK47388

Interventions

HSK47388 DRUG

HSK47388 tablets will be administered orally, once a day

HSK47388 dose 1 will be administered orally.; HSK47388 dose 2 will be administered orally.; HSK47388 dose 3 will be administered orally.; HSK47388 matching placebo will be administered orally.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): January 17, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08