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Purpose

The goal of this clinical trial is to learn about the safety and effectiveness of ENV-294 in adults with moderate to severe atopic dermatitis. The main questions it will answer are: - Is there an impact on the severity and area of atopic dermatitis when participants take ENV-294 - What medical problems do participants have when taking ENV-294 Participants will: - Take drug ENV-294 or a placebo once every day for 12 weeks - Visit the clinic every 2 to 4 weeks for checkups and tests - Keep a diary of their symptoms and when they took their study drug - Return to the clinic for the final study visit at approximately week 16

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have chronic atopic dermatitis that was diagnosed at least 12 months prior to the first study visit - Have moderate-to-severe AD at screening and baseline as defined by the following criteria: - A vIGA score of 3 (moderate) or 4 (severe) - EASI score of ≥16 - BSA ≥10% - PP-NRS score of ≥4 - Have had either a poor response or intolerance to topical treatments for atopic dermatitis (such as corticosteroids) within the past 6 months - Use a bland moisturizer at least daily

Exclusion Criteria

  • Current or recurrent medical conditions that could affect the study drug or study assessments - Any illness that could impact participant safety or active infections - Ongoing skin condition or large tattoos that would interfere with clinical assessment - Clinically significant skin infection requiring treatment - Clinically significant abnormal laboratory assessments at screening

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ENV-294 Treatment Arm 		ENV-294 will be administered to those participants randomized to the treatment arm.
  • Drug: ENV-294
    ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
Placebo Comparator
Placebo Arm 		A placebo will be administered to those participants randomized to the placebo arm.
  • Drug: Placebo
    Matching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.

Recruiting Locations

Enveda Investigative Site
Birmingham, Alabama 35244

Enveda Investigative Site
Hot Springs, Arkansas 71913

Enveda Investigative Site
Fremont, California 94538

Enveda Investigative Site
San Diego, California 92121

Enveda Investigative Site
San Diego, California 92123

Enveda Investigative Site
New Albany, Indiana 47150

Enveda Investigative Site
West Lafayette, Indiana 47906

Enveda Investigative Site
Louisville, Kentucky 40217

Enveda Investigative Site
Auburn Hills, Michigan 48326

Enveda Investigative Site
Clinton Township, Michigan 48038

Enveda Investigative Site
Las Vegas, Nevada 89145

Enveda Investigative Site
Canton, Ohio 44718

Enveda Investigative Site
Camp Hill, Pennsylvania 17011

Enveda Investigative Site
Arlington, Texas 76011

Enveda Investigative Site
Houston, Texas 77004

Enveda Investigative Site
San Antonio, Texas 78218

Enveda Investigative Site
Norfolk, Virginia 23502

More Details

Status
Recruiting
Sponsor
Enveda Therapeutics

Study Contact

Clinical Operations
env-294.clinicaltrials@enveda.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.