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This is a Phase 2 open label study of ATI-2138 in participants with moderate to severe atopic dermatitis.
This open-label, single-arm study of ATI-2138 in moderate to severe AD participants between the ages of 18 and 60 years (inclusive) will investigate the safety, tolerability, pharmacokinetics, efficacy and pharmacodynamics of ATI-2138 administered over 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATI-2138 | Experimental | ATI-2138 oral tablets BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATI-2138 | Drug | ATI-2138 Oral Tablets BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment emergent adverse events (TEAEs) | From baseline up to two weeks after treatment (Day 98) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Eczema Area and Severity Index (EASI) Over Time | Up to Week 12 | |
| Proportions of participants who achieve at least 50%, 75%, and 90% improvement in EASI Over Time | Up to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ajay Aggarwal, MD | Aclaris Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aclaris Investigational Site | Birmingham | Alabama | 35244 | United States | ||
| Aclaris Investigational Site |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017437 | Skin and Connective Tissue Diseases |
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| Proportion of participants achieving Investigator's Global Assessment-Treatment Success Over Time | Up to Week 12 |
| Change in IGA score over time | Up to Week 12 |
| Change from baseline in AD Body Surface Area (BSA) over time | Up to week 12 |
| Change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) over time | Up to Week 12 |
| ATI-2138 trough concentration ng/mL | Day 1 to Week 12 |
| ATI-2138 peak concentration (Cmax) ng/mL | Day 1 to Week 12 |
| Encino |
| California |
| 91436 |
| United States |
| Aclaris Investigational Site | San Diego | California | 92123 | United States |
| Aclaris Investigational Site | Plainfield | Indiana | 46168 | United States |
| Aclaris Investigational Site | Austin | Texas | 78759 | United States |
| Aclaris Investigational Site | San Antonio | Texas | 78213 | United States |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |