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HSK47388 in moderate to severe plaque psoriasis
NCT07158268Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Sep 2025
- Primary completion
- Dec 2026
- Modality
- Small Molecules
- Drugs
- HSK47388
- Conditions
- plaque psoriasis
01
Overview
Phase 2, randomised, double-blind trial of HSK47388 in plaque psoriasis (4 arms), sponsored by Haisco Pharmaceutical Group Co., Ltd. Primary endpoint: Percentage of Participants Achieving PASI 75 Response at 16 weeks. Planned start Sep 2025; status: not yet recruiting.
02
Design
4 arms- Study design
- RandomizedDouble-blind
HSK47388 Dose 1
HSK47388 oral tablets, Dose 1, once daily.
HSK47388 Dose 2
HSK47388 oral tablets, Dose 2, once daily.
HSK47388 Dose 3
HSK47388 oral tablets, Dose 3, once daily.
Placebo
Matching placebo oral tablets, once daily.
03
Who it enrols
Adults with moderate-to-severe plaque psoriasis (BSA >= 10%, PASI >= 12, IGA >= 3) for at least 26 weeks. Excludes non-plaque forms and significant organ disease.
04
Endpoints
Primary
Percentage of Participants Achieving PASI 75 Response
Secondary
Percentage of Participants Achieving an IGA Score of 0 or 1 and >=2 Grade Improvement
Change From Baseline in Body Surface Area (BSA)
Change From Baseline in Total DLQI Score
Number of Participants with Adverse Events
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