Status:
NOT_YET_RECRUITING
A Phase II Efficacy and Safety Study of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis
Lead Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy and safety of HSK44459 administered orally for moderate to severe plaque psoriasis in adults.
Detailed Description
Patients with moderate to severe plaque psoriasis will be randomized into 3 cohorts (dose level 1, dose level 2 and placebo). Approximately 150 subjects will be enrolled. This study includes an 16-wee...
Eligibility Criteria
Inclusion
- Fully understand and voluntarily participate this trial, and sign the informed consent form;
- Age≥18 years, regardless of gender;
- Plaque psoriasis;
- A candidate for systemic therapy;
- Agree to use a highly effective method(s) of from the signing of the informed consent form to 3 months post-treatment.
Exclusion
- Can not discontinue the prohibited medications specified in the protocol before the first dose and throughout the entire study period;
- Laboratory abnormalities with clinical significance;
- Forms of psoriasis other than chronic plaque-type;
- Presence of other dermatological or autoimmune diseases;
- Presence of active infection requiring systemic therapy;
- Has undergone or plans to undergo major surgery;
- History of cardiovascular or cerebrovascular diseases;
- History of suicide attempts or major psychiatric disorders;
- History of malignant tumors;
- History of gastrointestinal surgery or diseases that may have impact on the study;
- History of drug abuse, illicit drug use, or alcohol abuse;
- History of severe drug allergies;
- Pregnant or lactating women;
- Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
Key Trial Info
Start Date :
September 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 6 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07150988
Start Date
September 26 2025
End Date
November 6 2026
Last Update
September 2 2025
Active Locations (1)
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1
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China