Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis
- Registration Number
- NCT05579899
- Lead Sponsor
- Evommune, Inc.
- Brief Summary
This is a Phase 2a safety and efficacy study of EVO101 for the treatment of adults with atopic dermatitis
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
- Males or non-pregnant, non-lactating females, age 18 years or older
- Chronic atopic dermatitis for at least 1 year
- IGA score of 2 or 3
- BSA of AD involvement of 4-12%
- EASI of 5-20
- Significant AD flare with 4 weeks
- Use of biologic therapy within 12 weeks
- Regular use of tanning booth within 4 weeks
- Skin condition that could interfere with study assessments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EVO101 Cream EVO101 Active Treatment, BID, 8 weeks Vehicle Cream EVO101 Vehicle Treatment, BID, 8 weeks
- Primary Outcome Measures
Name Time Method Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8 8 weeks 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.
- Secondary Outcome Measures
Name Time Method Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8) 8 weeks 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.
Percent Body Surface Area (BSA) Affected by Atopic Dermatitis Over Time, Change From Baseline to Week 8 8 weeks 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.
Pruritus-NRS, Change From Baseline to Week 8 8 weeks 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".
Trial Locations
- Locations (21)
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States
DermResearch
🇺🇸Austin, Texas, United States
Dermatology Consulting Services, PLLC
🇺🇸High Point, North Carolina, United States
Pariser Dermatology Specialists
🇺🇸Norfolk, Virginia, United States
Dermatologists of Southwest Ohio
🇺🇸Mason, Ohio, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
J&S Studies, Inc
🇺🇸College Station, Texas, United States
Oregon Medical Research Center
🇺🇸Portland, Oregon, United States
Dermatology Research Associate
🇺🇸Los Angeles, California, United States
Minnesota Clinical Study Center
🇺🇸New Brighton, Minnesota, United States
Lenus Research and Medical Group
🇺🇸Miami, Florida, United States
Dawes Fretzin Clinical Research Group
🇺🇸Indianapolis, Indiana, United States
Center for Clinical Studies, Ltd LLC
🇺🇸Houston, Texas, United States
JDR Dermatology Research, LLC
🇺🇸Las Vegas, Nevada, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Metropolis Dermatology
🇺🇸Los Angeles, California, United States
Driven Research, LLC
🇺🇸Coral Gables, Florida, United States
Clinical Trials Institute of Northwest Arkansas
🇺🇸Fayetteville, Arkansas, United States
SkinSpecialists, LLC
🇺🇸Omaha, Nebraska, United States
Saguaro Dermatology
🇺🇸Phoenix, Arizona, United States
Northwest AR Clinical Trials Center, PLLC
🇺🇸Rogers, Arkansas, United States