Psoriasis
Conditions
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-week treatment Period, then a 4-week safety visit period.
Interventions
DRUGHSK44459 dose level 1
HSK44459 dose level 1 oral administration
DRUGHSK44459 dose level 2
HSK44459 dose level 2 orally administration
DRUGplacebo
placebo oral adminisitration
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving an IGA score of clear 0 or 1 with ≥2 point reduction from baseline. | 2, 4, 8, 12 and 16 weeks | Proportion of subjects achieving an IGA score of clear 0 or 1 with ≥2 point reduction at week 2, 4, 8, 12 and 16 from baseline. |
| Proportion of subjects who have ≥75% reduction in PASI (PASI-75). | 2, 4, 8 and 12 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 2, 4, 8 and 12. |
| Proportion of subjects who have ≥50% reduction in PASI (PASI-50). | 2, 4, 8, 12 and 16 weeks | The proportion of subjects who have a reduction of 50% or more from baseline in the psoriasis area-and-severity index score (PASI-50 at week 2, 4, 8, 12 and 16. |
| Proportion of subjects who have ≥90% reduction in PASI (PASI-90). | 2, 4, 8, 12 and 16 weeks | The proportion of subjects who have a reduction of 90% or more from baseline in the psoriasis area-and-severity index score (PASI-90) at week 2, 4, 8, 12 and 16. |
Countries
China
Contacts
Primary ContactYong Cao
Outcome results
None listed