A Phase 2 Study of HSK47388 Tablets to Evaluate the Efficacy and Safety in Patients With Moderate-to-Severe Plaque Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HSK47388.
- Who it may be relevant to
- Registry conditions: Plaque Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2 Multicenter, Randomized, Double-blind and Two-Stage Study to Evaluate the Efficacy and Safety of HSK47388 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Overview
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.
Interventions
- Drug HSK47388
HSK47388 tablets will be administered orally, once a day
Primary outcome measures
- HSK47388 and Placebo Group: Percentage of Participants Achieving PASI 75 Response From Baseline to week 16 [Time frame: 16 weeks]
Secondary outcome measures (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 [Time frame: 16 weeks]
- Change From Baseline in Body Surface Area (BSA) at Week 16 [Time frame: 16 weeks]
- HSK47388 and Placebo Group: Change From Baseline in Total DLQI Score at Week 16 [Time frame: 16 weeks]
- Number of Participants with Adverse Events (AEs) [Time frame: 20 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07158268 · HSK47388-201