Clinical Trials in China / NCT07150988
Starting soon
Phase 2
A Phase II Efficacy and Safety Study of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis
NCT07150988 · tracked via the Priya Life Science China tracker
Condition(s) studied
Psoriasis
Investigational drug(s) / intervention(s)
HSK44459 dose level 1: HSK44459 dose level 1 oral administration
HSK44459 dose level 2: HSK44459 dose level 2 orally administration
placebo: placebo oral adminisitration
Study 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.
Eligibility
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
- Proportion of subjects who have ≥75% reduction in PASI (PASI-75). — 16 weeks
The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 16.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hangzhou First People's Hospital | Hangzhou | Zhejiang |
More Haisco Pharmaceutical Group Co., Ltd. trials in China
Other trials for the same condition
Trial of HSK44459 Cream for the Management Plaque Psoriasis
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07150988 on ClinicalTrials.gov ↗ ← All trials in China