Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis

Atopic Dermatitis Eczema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05579899
• Other study ID #: EVO101-AD001
• Status: Completed
• Phase: Phase 2
• Start date: September 27, 2022
• Est. completion date: July 27, 2023

Study information

• Verified date: September 2023
• Source: Evommune, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2a safety and efficacy study of EVO101 for the treatment of adults with atopic dermatitis

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 information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 27, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• EVO101
Topical Cream

Locations

Country	Name	City	State
United States	DermResearch	Austin	Texas
United States	J&S Studies, Inc	College Station	Texas
United States	Driven Research, LLC	Coral Gables	Florida
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Clinical Trials Institute of Northwest Arkansas	Fayetteville	Arkansas
United States	Dermatology Consulting Services, PLLC	High Point	North Carolina
United States	Center for Clinical Studies, Ltd LLC	Houston	Texas
United States	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana
United States	JDR Dermatology Research, LLC	Las Vegas	Nevada
United States	Dermatology Research Associate	Los Angeles	California
United States	Metropolis Dermatology	Los Angeles	California
United States	Dermatologists of Southwest Ohio	Mason	Ohio
United States	Lenus Research and Medical Group	Miami	Florida
United States	Minnesota Clinical Study Center	New Brighton	Minnesota
United States	Pariser Dermatology Specialists	Norfolk	Virginia
United States	SkinSpecialists, LLC	Omaha	Nebraska
United States	Saguaro Dermatology	Phoenix	Arizona
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	Oregon Medical Research Center	Portland	Oregon
United States	Northwest AR Clinical Trials Center, PLLC	Rogers	Arkansas
United States	Clinical Science Institute	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Evommune, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eczema Area and Severity Index (EASI)	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
Secondary	Investigator Global Assessment (IGA)	The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale [0 (clear) to 4 (severe)].	8 weeks
Secondary	Body Surface Area (BSA)	BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area.	8 weeks
Secondary	Pruritus-NRS	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