Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis

NCT ID: NCT05579899

Last Updated: 2025-03-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-27

Study Completion Date

2023-07-27

Brief Summary

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

Detailed Description

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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.

Conditions

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Atopic Dermatitis Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Matching vehicle

Study Groups

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EVO101 Cream

Active Treatment, BID, 8 weeks

Group Type EXPERIMENTAL

EVO101

Intervention Type DRUG

Topical Cream

Vehicle Cream

Vehicle Treatment, BID, 8 weeks

Group Type PLACEBO_COMPARATOR

EVO101

Intervention Type DRUG

Topical Cream

Interventions

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EVO101

Topical Cream

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Evommune, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eugene Bauer, MD

Role: STUDY_DIRECTOR

Evommune, Inc.

Locations

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Saguaro Dermatology

Phoenix, Arizona, United States

Site Status

Clinical Trials Institute of Northwest Arkansas

Fayetteville, Arkansas, United States

Site Status

Northwest AR Clinical Trials Center, PLLC

Rogers, Arkansas, United States

Site Status

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Site Status

Metropolis Dermatology

Los Angeles, California, United States

Site Status

Dermatology Research Associate

Los Angeles, California, United States

Site Status

Clinical Science Institute

Santa Monica, California, United States

Site Status

Driven Research, LLC

Coral Gables, Florida, United States

Site Status

Lenus Research and Medical Group

Miami, Florida, United States

Site Status

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States

Site Status

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Site Status

Minnesota Clinical Study Center

New Brighton, Minnesota, United States

Site Status

SkinSpecialists, LLC

Omaha, Nebraska, United States

Site Status

JDR Dermatology Research, LLC

Las Vegas, Nevada, United States

Site Status

Dermatology Consulting Services, PLLC

High Point, North Carolina, United States

Site Status

Dermatologists of Southwest Ohio

Mason, Ohio, United States

Site Status

Oregon Medical Research Center

Portland, Oregon, United States

Site Status

DermResearch

Austin, Texas, United States

Site Status

J&S Studies, Inc

College Station, Texas, United States

Site Status

Center for Clinical Studies, Ltd LLC

Houston, Texas, United States

Site Status

Pariser Dermatology Specialists

Norfolk, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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EVO101-AD001

Identifier Type: -

Identifier Source: org_study_id

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