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The purpose of this study is to assess the efficacy and safety of HSK44459 in adults with Atopic Dermatitis
This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of HSK44459 in adult participants with Atopic Dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK44459-Dose level 1 | Experimental | Participants will receive HSK44459 for 12 weeks |
|
| HSK44459-Dose level 2 | Experimental | Participants will receive HSK44459 for 12 weeks |
|
| Placebo | Placebo Comparator | Participants will receive Placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK44459 | Drug | HSK44459 will be administered orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to week 12 in EASI | Evaluate the clinical efficacy of 2 dose levels of HSK44459, compared to placebo, in adult participants with atopic dermatitis (AD) using EASI. A total EASI score range from 0 to 72 points will be recorded for each assessment, with higher scores reflecting worse severity of AD | From Day 1 (first dose) to Day 85 (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with EASI-75 at week 12 | Proportion of patients with EASI-75 (≥75% improvement from baseline) at week 12 | From Day 1 (first dose) to Day 85 (week 12) |
| Proportion of patients with both IGA 0 to 1and a reduction from baseline of ≥2 points at week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Dermatology Hospital of Shandong First Medical University | Jinan | Shandong | 250022 | China |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Placebo | Drug | Placebo will be administered orally twice daily |
|
The IGA determines severity of AD and clinical response to treatment on a 5-point scale 0 = Clear
|
| From Day 1 (first dose) to Day 85 (week 12) |
| Proportion of patients with reduction of pruritus WI-NRS ≥3 or WI-NRS ≥4 from baseline to week 12 | The WI-NRS ranges from 0 = "no itch" to 10 ="worst imaginable itch" for the worst intensity itch in the preceding 24-hour period. | From Day 1 (first dose) to Day 85 (week 12) |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |