NCT07158268Not yet recruitingPhase 2
A Phase 2 Study of HSK47388 Tablets to Evaluate the Efficacy and Safety in Patients With Moderate-to-Severe Plaque Psoriasis
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
Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 28 Aug 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 20 Dec 2026
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Diseases
- Psoriasis
- NCT number
- NCT07158268
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 220
- From 1 Sept 2025 to the primary completion date, 20 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current drug-induced psoriasis
Other illness
- 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;
Other
- Non-plaque psoriasis (e.g., erythrodermic, guttate, or pustular psoriasis)
- Subjects deemed unsuitable for participation due to other factors as determined by the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.