Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis

Evommune, Inc.119 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

119

Conditions

Atopic Dermatitis Eczema

Interventions

EVO101DRUG

Topical Cream

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males or non-pregnant, non-lactating females, age 18 years or older 2. Chronic atopic dermatitis for at least 1 year 3. IGA score of 2 or 3 4. BSA of AD involvement of 4-12% 5. EASI of 5-20 Exclusion Criteria: 1. Significant AD flare with 4 weeks 2. Use of biologic therapy within 12 weeks 3. Regular use of tanning booth within 4 weeks 4. Skin condition that could interfere with study assessments

Locations (21)

Saguaro Dermatology

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 8 weeks

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.

Time frame: 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".

Time frame: 8 weeks

Data from ClinicalTrials.gov

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