Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT07158268
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07158268
Study Brief:
Protocol Section:
NCT07158268