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The purpose of this study is to assess the efficacy and safety of HSK44459 administered orally for moderate to severe plaque psoriasis in adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK44459 dose level 1 | Experimental | HSK44459 dosage 1 oral administration |
|
| HSK44459 dose level 2 | Experimental | HSK44459 dose level 2 oral administration |
|
| Placebo control | Placebo Comparator | placebo oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK44459 dose level 1 | Drug | HSK44459 dose level 1 oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who have ≥75% reduction in PASI (PASI-75). | 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. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving an IGA score of clear 0 or 1 with ≥2 point reduction from baseline. | 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. | 2, 4, 8, 12 and 16 weeks |
| Proportion of subjects who have ≥75% reduction in PASI (PASI-75). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Cao | Contact | 028-67258779 | caoyong@haisco.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| HSK44459 dose level 2 |
| Drug |
HSK44459 dose level 2 orally administration |
|
| placebo | Drug | placebo oral adminisitration |
|
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. |
| 2, 4, 8 and 12 weeks |
| Proportion of subjects who have ≥50% reduction in PASI (PASI-50). | 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. | 2, 4, 8, 12 and 16 weeks |
| Proportion of subjects who have ≥90% reduction in PASI (PASI-90). | 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. | 2, 4, 8, 12 and 16 weeks |