Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis

February 27, 2025 updated by: Evommune, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Saguaro Dermatology
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Clinical Trials Institute of Northwest Arkansas
      • Rogers, Arkansas, United States, 72758
        • Northwest AR Clinical Trials Center, PLLC
    • California
      • Encinitas, California, United States, 92024
        • California Dermatology & Clinical Research Institute
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associate
      • Los Angeles, California, United States, 90017
        • Metropolis Dermatology
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Driven Research, LLC
      • Miami, Florida, United States, 33172
        • Lenus Research and Medical Group
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Minnesota Clinical Study Center
    • Nebraska
      • Omaha, Nebraska, United States, 69144
        • SkinSpecialists, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • JDR Dermatology Research, LLC
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Dermatology Consulting Services, PLLC
    • Ohio
      • Mason, Ohio, United States, 45040
        • Dermatologists of Southwest Ohio
    • Oregon
      • Portland, Oregon, United States, 97223
        • Oregon Medical Research Center
    • Texas
      • Austin, Texas, United States, 78759
        • DermResearch
      • College Station, Texas, United States, 77845
        • J&S Studies, Inc
      • Houston, Texas, United States, 77004
        • Center for Clinical Studies, Ltd LLC
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Pariser Dermatology Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EVO101 Cream
Active Treatment, BID, 8 weeks
Drug: EVO101
Topical Cream
Placebo Comparator: Vehicle Cream
Vehicle Treatment, BID, 8 weeks
Drug: EVO101
Topical Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evommune, Inc.

Investigators

  • Study Director: Eugene Bauer, MD, Evommune, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2022

Primary Completion (Actual)

July 27, 2023

Study Completion (Actual)

July 27, 2023

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVO101-AD001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results published, after deidentification (text, tables, figures, and appendices)

IPD Sharing Time Frame

Following publication

IPD Sharing Access Criteria

to be determined

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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