Status:
NOT_YET_RECRUITING
A Phase 2 Study of HSK47388 Tablets to Evaluate the Efficacy and Safety in Patients With Moderate-to-Severe Plaque Psoriasis
Lead Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 17 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT07158268
Start Date
September 1 2025
End Date
January 17 2027
Last Update
September 5 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.