NCT06723405
Completed
Phase 2
A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study of EVO301 in Adults With Atopic Dermatitis
Overview
- Phase
- Phase 2
- Intervention
- EVO301
- Conditions
- Atopic Dermatitis (AD)
- Sponsor
- Evommune, Inc.
- Enrollment
- 71
- Locations
- 12
- Primary Endpoint
- Eczema Area and Severity Index (EASI)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
This is a Phase 2a efficacy and safety study of EVO301 for the treatment of adults with atopic dermatitis.
Detailed Description
This is a Phase 2a efficacy and safety study of intravenous EVO301 in adults with moderate to severe atopic dermatitis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males or non-pregnant, non-lactating females, age 18 years or older
- •Chronic atopic dermatitis for at least 6 months
- •BSA of AD involvement of at least 10%
- •EASI score of at least 16.
Exclusion Criteria
- •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
Arms & Interventions
Intravenous EVO301
Intervention: EVO301
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Eczema Area and Severity Index (EASI)
Time Frame: 12 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 Outcomes
- Investigator Global Assessment (IGA)(12 weeks)
- Body Surface Area (BSA)(12 weeks)
- Pruritus-NRS(12 weeks)
Study Sites (12)
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