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This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of CM326 in moderate-severe atopic dermatitis subjects.
The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Group A: CM326, subcutaneous (SC) |
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| Group B | Experimental | Group A: CM326, subcutaneous (SC) |
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| Group C | Placebo Comparator | Group C: placebo, subcutaneous (SC) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM326 | Biological | CM326 injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at visit 16 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD | at week 16 |
| Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and reduction from baseline of ≥2 points at Visit 16 | IGA is a 5-point scale ranging from 0 (clear) to 4 (very severe) | at week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Jia | Contact | +862888610620 | qianjia@keymedbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's hospital | Recruiting | Beijing | China |
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| Placebo |
| Other |
Placebo |
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