A Phase II Efficacy and Safety Study of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HSK44459 dose level 1, HSK44459 dose level 2, placebo.
- Who it may be relevant to
- Registry conditions: Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis
Overview
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-week treatment Period, then a 4-week safety visit period.
Interventions
- Drug HSK44459 dose level 1
HSK44459 dose level 1 oral administration - Drug HSK44459 dose level 2
HSK44459 dose level 2 orally administration - Drug placebo
placebo oral adminisitration
Primary outcome measures
- Proportion of subjects who have ≥75% reduction in PASI (PASI-75). [Time frame: 16 weeks]
Secondary outcome measures (4)
- Proportion of subjects achieving an IGA score of clear 0 or 1 with ≥2 point reduction from baseline. [Time frame: 2, 4, 8, 12 and 16 weeks]
- Proportion of subjects who have ≥75% reduction in PASI (PASI-75). [Time frame: 2, 4, 8 and 12 weeks]
- Proportion of subjects who have ≥50% reduction in PASI (PASI-50). [Time frame: 2, 4, 8, 12 and 16 weeks]
- Proportion of subjects who have ≥90% reduction in PASI (PASI-90). [Time frame: 2, 4, 8, 12 and 16 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Hangzhou First People's Hospital — Hangzhou
Identifiers
NCT: NCT07150988 · HSK44459-206