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This study will evaluate the efficacy and safety of different doses of EVO756 in adults with moderate to severe atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | Orally administered EVO756, Dose 1 |
|
| Dose 2 | Experimental | Orally administered EVO756, Dose 2 |
|
| Dose 3 | Experimental | Orally administered EVO756, Dose 3 |
|
| Placebo | Placebo Comparator | Placebo control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVO756 | Drug | Dose 1 |
| |
| EVO756 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in Eczema Area and Severity Index (EASI) from Baseline | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in EASI from Baseline | Weeks 2, 4, and 8 | |
| Mean changes in EASI from Baseline | Week 2, 4, 8, and 12 | |
| Proportion of subjects with EASI-50, EASI-75, and EASI-90 from Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saguaro Dermatology | Phoenix | Arizona | 85008 | United States | ||
| Center for Dermatology Clinical Research |
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| Drug |
Dose 2 |
|
| EVO756 | Drug | Dose 3 |
|
| Placebo control | Drug | Placebo control |
|
| Weeks 2, 4, 8, and 12 |
| Mean and absolute changes in validated Investigator Global Assessment (vIGA) score from Baseline | Weeks 2, 4, 8, and 12 |
| Proportion of subjects achieving a vIGA score of 0,1 with at least a 2-point reduction from Baseline | Weeks 2, 4, 8, and 12 |
| Mean and percentage change from Baseline in the pruritus-NRS score | Weeks 2, 4, 8, and 12 |
| Proportion of subjects achieving a 4-pt reduction in the pruritus-NRS score from Baseline | Week 2, 4, 8, and 12 |
| Mean and percentage changes from Baseline in Body Surface Area (BSA) of affected area | Weeks 2, 4, 8, and 12 |
| Occurrence of treatment emergent adverse events (TEAE) and serious adverse events (SAE) | through Week 14 |
| Fremont |
| California |
| 94538 |
| United States |
| Metropolis Dermatology - Downtown Los Angeles | Los Angeles | California | 90017 | United States |
| Skin and Beauty Center | Pasadena | California | 91105 | United States |
| Skin Care Research, LLC | Boca Raton | Florida | 33486 | United States |
| Driven Research, LLC | Coral Gables | Florida | 33134 | United States |
| Skin Care Research - Hollywood Dermatology | Hollywood | Florida | 33021 | United States |
| TrueBlue Clinical Research | Tampa | Florida | 33609 | United States |
| DS Research | Clarksville | Indiana | 47129 | United States |
| Equity Medical | Bowling Green | Kentucky | 42104 | United States |
| Aesthetic and Dermatology Center | Rockville | Maryland | 20850 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| Revival Research Institute, LLC | Troy | Michigan | 48084 | United States |
| Michigan Dermatology Institute | Waterford | Michigan | 48328 | United States |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64507 | United States |
| Empire Dermatology | East Syracuse | New York | 13057 | United States |
| Equity Medical | New York | New York | 10023 | United States |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | United States |
| Wilmington Dermatology Center | Wilmington | North Carolina | 28405 | United States |
| DOCS Dermatology Clinical Research | Canal Winchester | Ohio | 43110 | United States |
| International Clinical Research - Murfreesboro | Murfreesboro | Tennessee | 37130 | United States |
| Stryde Research | Lewisville | Texas | 75056 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Jordan Valley Dermatology Center | South Jordan | Utah | 84095 | United States |
| Pacific Clinical Research Network (PCRN) - Christchurch | Christchurch Central City | Christchurch | 8013 | New Zealand |
| Optimal Clinical Trials | Auckland | NZL | 1010 | New Zealand |
| Optimal Clinical Trials | Auckland | NZL | 632 | New Zealand |
| Clinical Trials NZ Limited | Hamilton | NZL | 3204 | New Zealand |
| Momentum Clinical Research Lower Hutt | Lower Hutt | NZL | 5010 | New Zealand |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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