Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tigermed Consulting Co., Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This Phase 3, double-blind (sponsor-open), multicenter, placebo-controlled study aims to evaluate the efficacy and safety of oral LW402 tablets in patients with moderate to severe atopic dermatitis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LW402 100 mg, PO BID | Experimental |
| |
| LW402 150 mg, PO BID | Experimental |
| |
| LW402 placebo tablets,PO.BID | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LW402 | Drug | LW402 tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving ≥75% improvement in Eczema Area and Severity Index (EASI) from baseline at Week 16 (EASI 75) | Week 16 | |
| Proportion of subjects achieving an Investigator's Global Assessment (IGA) score of 0 or 1 with a ≥2-point reduction from baseline at Week 16 | Week 16 |
Not provided
Not provided
Inclusion Criteria:
Subjects voluntarily provided informed consent and agreed to participate in the study.
Gender: no restrictions; Age: 18 to 75 years inclusive (as of the date of signing the informed consent form).
At screening, subjects met the Hanifin-Rajka diagnostic criteria for atopic dermatitis (AD) (Appendix 4) and had a documented AD history of ≥1 year prior to screening.
At screening and baseline visits, subjects were required to have moderate-to-severe atopic dermatitis (AD) with all three of the following criteria satisfied:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara Chen | Contact | +86-21-63634910 | barbara@lwbiopharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Janzhong Zhang | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
LW402 placebo tablets |
|