NCT05579899

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 5, 2025

Completed
Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

October 11, 2022

Results QC Date

October 8, 2024

Last Update Submit

February 27, 2025

Conditions

Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8

    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 Outcomes (3)

  • Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8)

    8 weeks

  • Percent Body Surface Area (BSA) Affected by Atopic Dermatitis Over Time, Change From Baseline to Week 8

    8 weeks

  • Pruritus-NRS, Change From Baseline to Week 8

    8 weeks

Study Arms (2)

EVO101 Cream

EXPERIMENTAL

Active Treatment, BID, 8 weeks

Drug: EVO101

Vehicle Cream

PLACEBO COMPARATOR

Vehicle Treatment, BID, 8 weeks

Drug: EVO101

Interventions

EVO101DRUG

Topical Cream

EVO101 CreamVehicle Cream

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Saguaro Dermatology

Phoenix, Arizona, 85008, United States

Location

Clinical Trials Institute of Northwest Arkansas

Fayetteville, Arkansas, 72703, United States

Location

Northwest AR Clinical Trials Center, PLLC

Rogers, Arkansas, 72758, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Metropolis Dermatology

Los Angeles, California, 90017, United States

Location

Dermatology Research Associate

Los Angeles, California, 90045, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Driven Research, LLC

Coral Gables, Florida, 33134, United States

Location

Lenus Research and Medical Group

Miami, Florida, 33172, United States

Location

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46250, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

SkinSpecialists, LLC

Omaha, Nebraska, 69144, United States

Location

JDR Dermatology Research, LLC

Las Vegas, Nevada, 89148, United States

Location

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262, United States

Location

Dermatologists of Southwest Ohio

Mason, Ohio, 45040, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

DermResearch

Austin, Texas, 78759, United States

Location

J&S Studies, Inc

College Station, Texas, 77845, United States

Location

Center for Clinical Studies, Ltd LLC

Houston, Texas, 77004, United States

Location

Pariser Dermatology Specialists

Norfolk, Virginia, 23502, United States

Location

Results Point of Contact

Title
Eugene Bauer, M.D., Chief Medical Officer
Organization
Evommune
eugene.bauer@evommune.com
310-721-3364

Study Officials

  • Eugene Bauer, MD

    Evommune, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Matching vehicle
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 14, 2022

Study Start

September 27, 2022

Primary Completion

July 27, 2023

Study Completion

July 27, 2023

Last Updated

March 5, 2025

Results First Posted

March 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
Following publication
Access Criteria
to be determined

Locations

US(21)