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Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05579899
Recruitment Status : Recruiting
First Posted : October 14, 2022
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
Evommune, Inc.

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Drug: EVO101 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Matching vehicle
Primary Purpose: Treatment
Official Title: A Randomized, Vehicle-controlled, Safety and Efficacy Study of EVO101 in Adult Subjects With Atopic Dermatitis
Actual Study Start Date : September 27, 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




Primary Outcome Measures :
  1. Eczema Area and Severity Index (EASI) [ 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 Outcome Measures :
  1. Investigator Global Assessment (IGA) [ 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)].

  2. Body Surface Area (BSA) [ Time Frame: 8 weeks ]
    BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area.

  3. Pruritus-NRS [ 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".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05579899


Contacts
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Contact: Janice Drew 650-223-7745 janice.drew@evommune.com

Locations
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United States, Arkansas
Northwest AR Clinical Trials Center, PLLC Recruiting
Rogers, Arkansas, United States, 72758
United States, California
Dermatology Research Associate Recruiting
Los Angeles, California, United States, 90045
Clinical Science Institute Recruiting
Santa Monica, California, United States, 90404
United States, Florida
Driven Research, LLC Recruiting
Coral Gables, Florida, United States, 33134
Lenus Research and Medical Group Recruiting
Miami, Florida, United States, 33172
United States, Indiana
The Indiana Clinical Trials Center Recruiting
Plainfield, Indiana, United States, 46168
United States, Minnesota
Minnesota Clinical Study Center Recruiting
New Brighton, Minnesota, United States, 55112
United States, Nebraska
SkinSpecialists, LLC Recruiting
Omaha, Nebraska, United States, 69144
United States, Nevada
JDR Dermatology Research, LLC Recruiting
Las Vegas, Nevada, United States, 89148
United States, North Carolina
Dermatology Consulting Services, PLLC Recruiting
High Point, North Carolina, United States, 27262
United States, Oregon
Oregon Medical Research Center Recruiting
Portland, Oregon, United States, 97223
United States, Texas
DermResearch Recruiting
Austin, Texas, United States, 78759
J&S Studies, Inc Recruiting
College Station, Texas, United States, 77845
Center for Clinical Studies, Ltd LLC Recruiting
Houston, Texas, United States, 77004
United States, Virginia
Pariser Dermatology Specialists Recruiting
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Evommune, Inc.
Investigators
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Study Director: Eugene Bauer, MD Evommune, Inc.
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Responsible Party: Evommune, Inc.
ClinicalTrials.gov Identifier: NCT05579899    
Other Study ID Numbers: EVO101-AD001
First Posted: October 14, 2022    Key Record Dates
Last Update Posted: November 3, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results published, after deidentification (text, tables, figures, and appendices)
Supporting Materials: Study Protocol
Time Frame: Following publication
Access Criteria: to be determined

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases