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This is a Phase 2a efficacy and safety study of EVO301 for the treatment of adults with atopic dermatitis.
This is a Phase 2a efficacy and safety study of intravenous EVO301 in adults with moderate to severe atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous EVO301 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVO301 | Biological | Intravenous EVO301 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Eczema Area and Severity Index (EASI) | EASI assesses the extent and severity of atopic dermatitis. EASI is a composite index with scores ranging from 0 to 72. Higher values indicate more severe or extensive disease. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment (IGA) | The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale [0 (clear) to 4 (severe)]. | 12 weeks |
| Body Surface Area (BSA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornerstone Dermatology | Coorparoo | QLD 4151 | Australia | |||
| Momentum Clinical Research Darlinghurst |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Biological |
Placebo |
|
BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area.
| 12 weeks |
| Pruritus-NRS | The pruritus-NRS is an 11-point scale used by subjects to rate their worst itch severity over the past 24 hours with 0 indicating "no itch" and 10 indicating "worst itch imaginable". | 12 weeks |
| Darlinghurst |
| NSW 2010 |
| Australia |
| Pacific Clinical Research Network (PCRN) Auckland | Auckland | 0622 | New Zealand |
| Optimal Clinical Trials North | Auckland | 0632 | New Zealand |
| Optimal Clinical Trials | Auckland | 1010 | New Zealand |
| Pacific Clinical Research Network (PCRN) Christchurch | Christchurch | 8013 | New Zealand |
| Momentum Clinical Research Dunedin | Dunedin | 9016 | New Zealand |
| Clinical Trials New Zealand Ltd | Hamilton | 3204 | New Zealand |
| Momentum Clinical Research Lower Hutt | Hutt Central | 5010 | New Zealand |
| Pacific Clinical Research Network (PCRN) Tasman | Nelson | 7011 | New Zealand |
| Momentum Clinical Research Kapiti | Paraparaumu | 5032 | New Zealand |
| Momentum Clinical Research Pukekohe | Pukekohe | 2120 | New Zealand |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |