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This is a dose escalation study to test the safety, tolerability and preliminary efficacy of ASN002 in people with moderate to severe atopic dermatitis (AD).
This study is a dose escalation study to determine a safe and tolerable dose of ASN002 for people with moderate to severe atopic dermatitis. This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and skin biopsies. Subjects will also be assessed for improvement in their atopic dermatitis. There will be a screening period (up to 30 days) and a treatment period for 4 weeks with a 14 day follow up with an end-of-study visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASN002 40 mg | Experimental | 40 mg ASN002 |
|
| ASN002 80 mg | Experimental | 80 mg ASN002 |
|
| ASN002 20 mg | Experimental | 20 mg ASN002 |
|
| ASN002 120 mg | Experimental | 120 mg ASN002 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASN002 | Drug | Daily dose of ASN002 for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximum tolerated dose of ASN002 | Analyze the number and type of adverse events reported. | 43 days |
| Measure | Description | Time Frame |
|---|---|---|
| Calculate the area under the plasma concentration versus time curve | A plot of the concentrations of ASN002 in blood plasma over time. | 16 Days |
| Calculate the Pharmacokinetic maximum concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pharmacodynamics biomarkers in serum | Measurement of inflammatory markers including immune markers and CRP | 28 days |
| Change from baseline in pharmacodynamics biomarkers in skin |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Zammit, Ph.D. | Asana BioSciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States | ||
| Dermatology Research Associates |
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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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| ID | Term |
|---|---|
| C000707471 | gusacitinib |
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Double blind study
| Placebo Oral Tablet | Drug | Placebo for ASN002 for 28 days |
|
Maximum concentration of ASN002 achieved after dosing.
| 16 Days |
| Calculate the Pharmacokinetic Half-life | The time required for ASN002 concentration to decrease by 50% | 16 Days |
| Change from baseline in the Investigator Global Assessment | determine overall severity of atopic dermatitis | 28 days |
| Change from baseline in the subject-reported puritis (itch) score | Rating of puritis based degree, duration, direction, disability, and distribution | 28 days |
| Change from baseline in EASI score | Measurement of area and severity of atopic dermatitis | 28 days |
Epidermal thickness and barrier markers from skin biopsies
| 28 |
| Los Angeles |
| California |
| 30045 |
| United States |
| TCR Medical Corporation | San Diego | California | 92123 | United States |
| Olympian Clinical Research | Tampa | Florida | 33609 | United States |
| Forward Clinical Trials, Inc. | Tampa | Florida | 33624 | United States |
| Dermatology Specialists Research | Louisville | Kentucky | 40241 | United States |
| Center for Clinical Studies, Ltd., LLP | Houston | Texas | 77004 | United States |
| Progressive Clinical Research, P.A. | San Antonio | Texas | 78229 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| Innovaderm Research | Montreal | Canada |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |