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This is a multi-center, randomized, double blind, placebo-controlled phase 2 study to evaluate the efficacy, safety, PK and PD ofLW402 in patients with moderate-to-severe atopic dermatitis.
The study consists of an up-to-4-week screening period, a 12-week double-blind treatment period and a 4-week safety follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LW402 Low Dose | Experimental | LW402 administered orally, BID (low dose) |
|
| LW402 Medium Dose | Experimental | LW402 administered orally, BID (medium dose) |
|
| LW402 High Dose | Experimental | LW402 administered orally, BID (high dose) |
|
| Placebo | Placebo Comparator | LW402 placebo administered orally, BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LW402 | Drug | LW402 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving EASI-50 at week 12 | Proportion of participants achieving EASI-50 (≥50% reduction from baseline in Eczema Area and Severity Index score) at week 12. The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving EASI-75 at week 12 | Proportion of participants achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score) at week 12. | 12 weeks |
| Proportion of participants with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 12 |
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Inclusion Criteria:
Exclusion Criteria:
pregnancy. Other.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | 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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| LW402 placebo | Drug | LW402 placebo tablets |
|
Proportion of participants with Investigator's Global Assessment (IGA) score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16. IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 6-point scale ranging from 0 (clear) to 5 (very severe). |
| 12 weeks |
| Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. | Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. | 16 weeks |
| PD: pSTAT3 and pSTAT5 inhibition rates | 12 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |