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This is a Phase 2a safety and efficacy study of EVO101 for the treatment of adults with atopic dermatitis
This is a Phase 2a safety and efficacy study of EVO101 Topical Cream, 0.1%, applied twice daily for 8 weeks in adults with mild-to moderate atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVO101 Cream | Experimental | Active Treatment, BID, 8 weeks |
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| Vehicle Cream | Placebo Comparator | Vehicle Treatment, BID, 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVO101 | Drug | Topical Cream |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8 | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8) | The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale [0 (clear) to 4 (severe)]. The outcome measures is reported as the number of participants achieving a reduction of 2 or greater on the IGA from baseline to Week 8. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Bauer, MD | Evommune, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saguaro Dermatology | Phoenix | Arizona | 85008 | United States | ||
| Clinical Trials Institute of Northwest Arkansas |
Individual participant data that underlie the results published, after deidentification (text, tables, figures, and appendices)
Following publication
to be determined
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| ID | Title | Description |
|---|---|---|
| FG000 | EVO101 Cream | Active Treatment, BID, 8 weeks EVO101: Topical Cream |
| FG001 | Vehicle Cream | Vehicle Treatment, BID, 8 weeks EVO101: Topical Cream |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2023 | Nov 20, 2024 |
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Matching vehicle
| Percent Body Surface Area (BSA) Affected by Atopic Dermatitis Over Time, Change From Baseline to Week 8 | BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area. The outcome measure describes the mean change from baseline in percent of the body surface area affected by AD. | 8 weeks |
| Pruritus-NRS, Change From Baseline to Week 8 | 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". | 8 weeks |
| Fayetteville |
| Arkansas |
| 72703 |
| United States |
| Northwest AR Clinical Trials Center, PLLC | Rogers | Arkansas | 72758 | United States |
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | United States |
| Metropolis Dermatology | Los Angeles | California | 90017 | United States |
| Dermatology Research Associate | Los Angeles | California | 90045 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| Driven Research, LLC | Coral Gables | Florida | 33134 | United States |
| Lenus Research and Medical Group | Miami | Florida | 33172 | United States |
| Dawes Fretzin Clinical Research Group | Indianapolis | Indiana | 46250 | United States |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| Minnesota Clinical Study Center | New Brighton | Minnesota | 55112 | United States |
| SkinSpecialists, LLC | Omaha | Nebraska | 69144 | United States |
| JDR Dermatology Research, LLC | Las Vegas | Nevada | 89148 | United States |
| Dermatology Consulting Services, PLLC | High Point | North Carolina | 27262 | United States |
| Dermatologists of Southwest Ohio | Mason | Ohio | 45040 | United States |
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States |
| DermResearch | Austin | Texas | 78759 | United States |
| J&S Studies, Inc | College Station | Texas | 77845 | United States |
| Center for Clinical Studies, Ltd LLC | Houston | Texas | 77004 | United States |
| Pariser Dermatology Specialists | Norfolk | Virginia | 23502 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | EVO101 Cream | Active Treatment, BID, 8 weeks EVO101: Topical Cream |
| BG001 | Vehicle Cream | Vehicle Treatment, BID, 8 weeks EVO101: Topical Cream |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8 | 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. | All participants assigned to EVO101 or Vehicle treatment. | Posted | Mean | Standard Deviation | Percent change from baseline | 8 weeks |
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| Secondary | Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8) | The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale [0 (clear) to 4 (severe)]. The outcome measures is reported as the number of participants achieving a reduction of 2 or greater on the IGA from baseline to Week 8. | Participants assigned to EVO101 or Vehicle with available data at Week 8 | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | Percent Body Surface Area (BSA) Affected by Atopic Dermatitis Over Time, Change From Baseline to Week 8 | BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area. The outcome measure describes the mean change from baseline in percent of the body surface area affected by AD. | Participants assigned to EVO101 or Vehicle with available data at Week 8 | Posted | Mean | Standard Deviation | percentage of total body surface area | 8 weeks |
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| Secondary | Pruritus-NRS, Change From Baseline to Week 8 | 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". | Participants assigned to EVO101 or Vehicle with available data at Week 8 | Posted | Mean | Standard Deviation | Change in units on a scale | 8 weeks |
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12 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EVO101 Cream | Active Treatment, BID, 8 weeks EVO101: Topical Cream | 0 | 60 | 0 | 60 | 19 | 60 |
| EG001 | Vehicle Cream | Vehicle Treatment, BID, 8 weeks EVO101: Topical Cream | 0 | 58 | 0 | 58 | 30 | 58 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Application site erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Application site oedema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Application site pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Application site dryness | Surgical and medical procedures | Systematic Assessment |
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| Application site exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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Upon written approval by Evommune, the PI may publicly disclose site results for only (1) non-commercial and (2) internal scientific research and educational purposes
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eugene Bauer, M.D., Chief Medical Officer | Evommune | 310-721-3364 | eugene.bauer@evommune.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2023 | Nov 20, 2024 | SAP_002.pdf |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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