A Randomized, Vehicle-controlled, Safety and Efficacy Study of EVO101 in Adult Subjects With Atopic Dermatitis

Evommune, Inc.21 sites in 1 country119 target enrollmentSeptember 27, 2022

ConditionsAtopic Dermatitis Eczema

InterventionsEVO101

DrugsEVO101

Overview

Phase: Phase 2
Intervention: EVO101
Conditions: Atopic Dermatitis Eczema
Sponsor: Evommune, Inc.
Enrollment: 119
Locations: 21
Primary Endpoint: Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 27, 2022

End Date

July 27, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Evommune, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

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

EVO101 Cream

Active Treatment, BID, 8 weeks

Intervention: EVO101

Vehicle Cream

Vehicle Treatment, BID, 8 weeks

Intervention: EVO101

Outcomes

Primary Outcomes

Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8

Time Frame: 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 Outcomes

Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8)(8 weeks)
Percent Body Surface Area (BSA) Affected by Atopic Dermatitis Over Time, Change From Baseline to Week 8(8 weeks)
Pruritus-NRS, Change From Baseline to Week 8(8 weeks)