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Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis

Sponsor
Evommune, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05579899
Collaborator
(none)
118
Enrollment
15
Locations
2
Arms
7.1
Anticipated Duration (Months)
7.9
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 27, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Eczema Area and Severity Index (EASI) [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) [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) [8 weeks]

    BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area.

  3. Pruritus-NRS [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".

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwest AR Clinical Trials Center, PLLC Rogers Arkansas United States 72758
2 Dermatology Research Associate Los Angeles California United States 90045
3 Clinical Science Institute Santa Monica California United States 90404
4 Driven Research, LLC Coral Gables Florida United States 33134
5 Lenus Research and Medical Group Miami Florida United States 33172
6 The Indiana Clinical Trials Center Plainfield Indiana United States 46168
7 Minnesota Clinical Study Center New Brighton Minnesota United States 55112
8 SkinSpecialists, LLC Omaha Nebraska United States 69144
9 JDR Dermatology Research, LLC Las Vegas Nevada United States 89148
10 Dermatology Consulting Services, PLLC High Point North Carolina United States 27262
11 Oregon Medical Research Center Portland Oregon United States 97223
12 DermResearch Austin Texas United States 78759
13 J&S Studies, Inc College Station Texas United States 77845
14 Center for Clinical Studies, Ltd LLC Houston Texas United States 77004
15 Pariser Dermatology Specialists Norfolk Virginia United States 23502

Sponsors and Collaborators

  • Evommune, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Evommune, Inc.
ClinicalTrials.gov Identifier:
NCT05579899
Other Study ID Numbers:
  • EVO101-AD001
First Posted:
Oct 14, 2022
Last Update Posted:
Nov 3, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Eczema

Study Results

No Results Posted as of Nov 3, 2022