Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis

Phase 2

Completed

• Conditions: Atopic Dermatitis Eczema
• Interventions: Drug: EVO101

• 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.

Study Timeline

• Study Start: 2022-09-27
• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-14
• Primary Completion: 2023-07-27
• Study Completion: 2023-07-27
• Results First Submitted: 2024-10-08
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Results First Posted: 2025-03-05
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

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)

Saguaro Dermatology; 🇺🇸 Phoenix, Arizona, United States

Clinical Trials Institute of Northwest Arkansas; 🇺🇸 Fayetteville, Arkansas, United States

Northwest AR Clinical Trials Center, PLLC; 🇺🇸 Rogers, Arkansas, United States

California Dermatology & Clinical Research Institute; 🇺🇸 Encinitas, California, United States

Metropolis Dermatology; 🇺🇸 Los Angeles, California, United States

Dermatology Research Associate; 🇺🇸 Los Angeles, California, United States

Clinical Science Institute; 🇺🇸 Santa Monica, California, United States

Driven Research, LLC; 🇺🇸 Coral Gables, Florida, United States

Lenus Research and Medical Group; 🇺🇸 Miami, Florida, United States

Dawes Fretzin Clinical Research Group; 🇺🇸 Indianapolis, Indiana, United States

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