A Phase II Efficacy and Safety Study of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis

Sponsor
Haisco Pharmaceutical Group Co., Ltd.
Study ID
NCT07150988
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HSK44459 dose level 1 — DRUG
    HSK44459 dose level 1 oral administration
  • HSK44459 dose level 2 — DRUG
    HSK44459 dose level 2 orally administration
  • placebo — DRUG
    placebo oral adminisitration

Study Details

The purpose of this study is to assess the efficacy and safety of HSK44459 administered orally for moderate to severe plaque psoriasis in adults.

Key Dates

First listed
Sep 2, 2025
Start date
Sep 26, 2025
Status verified
Aug 2025
Primary completion
Nov 6, 2026
Completion
Nov 6, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HSK44459 dose level 1
    HSK44459 dosage 1 oral administration
  • Experimental: HSK44459 dose level 2
    HSK44459 dose level 2 oral administration
  • Placebo Comparator: Placebo control
    placebo oral administration

Primary Outcome Measure

Proportion of subjects who have ≥75% reduction in PASI (PASI-75). [ Time Frame: 16 weeks ]

Central Contacts

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