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Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis

Primary Purpose

Atopic Dermatitis Eczema

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EVO101
Sponsored by
Evommune, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis Eczema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Saguaro Dermatology
  • Clinical Trials Institute of Northwest Arkansas
  • Northwest AR Clinical Trials Center, PLLC
  • California Dermatology & Clinical Research Institute
  • Metropolis Dermatology
  • Dermatology Research Associate
  • Clinical Science Institute
  • Driven Research, LLC
  • Lenus Research and Medical Group
  • Dawes Fretzin Clinical Research Group
  • The Indiana Clinical Trials Center
  • Minnesota Clinical Study Center
  • SkinSpecialists, LLC
  • JDR Dermatology Research, LLC
  • Dermatology Consulting Services, PLLC
  • Dermatologists of Southwest Ohio
  • Oregon Medical Research Center
  • DermResearch
  • J&S Studies, Inc
  • Center for Clinical Studies, Ltd LLC
  • Pariser Dermatology Specialists

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EVO101 Cream

Vehicle Cream

Arm Description

Active Treatment, BID, 8 weeks

Vehicle Treatment, BID, 8 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)].
Body Surface Area (BSA)
BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area.
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".

Full Information

First Posted
October 11, 2022
Last Updated
September 5, 2023
Sponsor
Evommune, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05579899
Brief Title
Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis
Official Title
A Randomized, Vehicle-controlled, Safety and Efficacy Study of EVO101 in Adult Subjects With Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 27, 2022 (Actual)
Primary Completion Date
July 27, 2023 (Actual)
Study Completion Date
July 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evommune, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Matching vehicle
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EVO101 Cream
Arm Type
Experimental
Arm Description
Active Treatment, BID, 8 weeks
Arm Title
Vehicle Cream
Arm Type
Placebo Comparator
Arm Description
Vehicle Treatment, BID, 8 weeks
Intervention Type
Drug
Intervention Name(s)
EVO101
Intervention Description
Topical Cream
Primary Outcome Measure Information:
Title
Eczema Area and Severity Index (EASI)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Investigator Global Assessment (IGA)
Description
The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale [0 (clear) to 4 (severe)].
Time Frame
8 weeks
Title
Body Surface Area (BSA)
Description
BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area.
Time Frame
8 weeks
Title
Pruritus-NRS
Description
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".
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Bauer, MD
Organizational Affiliation
Evommune, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Saguaro Dermatology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Clinical Trials Institute of Northwest Arkansas
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Northwest AR Clinical Trials Center, PLLC
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Metropolis Dermatology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Dermatology Research Associate
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Driven Research, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Lenus Research and Medical Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Minnesota Clinical Study Center
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
SkinSpecialists, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
69144
Country
United States
Facility Name
JDR Dermatology Research, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Dermatology Consulting Services, PLLC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Dermatologists of Southwest Ohio
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
DermResearch
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J&S Studies, Inc
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Center for Clinical Studies, Ltd LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Pariser Dermatology Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis

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