Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
Recruiting · NCT07298395 · Interventional (participants receive a specific treatment) · Lead sponsor: Enveda Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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
Where it is running
32 locations listed across 16 US states.
- Enveda Investigative Site - Birmingham, Alabama, United States
- Enveda Investigative Site - Hot Springs, Arkansas, United States
- Enveda Investigative Site - Beverly Hills, California, United States
- Enveda Investigative Site - Fremont, California, United States
- Enveda Investigative Site - San Diego, California, United States
- Enveda Investigative Site - San Diego, California, United States
- Enveda Investigative Site - Santa Monica, California, United States
- Enveda Investigative Site - West Hills, California, United States
- Enveda Investigative Site - Fort Lauderdale, Florida, United States
- Enveda Investigative Site - Miami, Florida, United States
- Enveda Investigative Site - Miramar, Florida, United States
- Enveda Investigative Site - Atlanta, Georgia, United States
- Enveda Investigative Site - Chicago, Illinois, United States
- Enveda Investigative Site - Clarksville, Indiana, United States
- Enveda Investigative Site - New Albany, Indiana, United States
- Enveda Investigative Site - West Lafayette, Indiana, United States
- Enveda Investigative Site - Louisville, Kentucky, United States
- Enveda Investigative Site - Louisville, Kentucky, United States
- Enveda Investigative Site - Auburn Hills, Michigan, United States
- Enveda Investigative Site - Bay City, Michigan, United States
- Enveda Investigative Site - Clinton Township, Michigan, United States
- Enveda Investigative Site - Warren, Michigan, United States
- Enveda Investigative Site - Las Vegas, Nevada, United States
- Enveda Investigative Site - New York, New York, United States
- Enveda Investigative Site - Wilmington, North Carolina, United States
- Enveda Investigative Site - Canton, Ohio, United States
- Enveda Investigative Site - Mayfield Heights, Ohio, United States
- Enveda Investigative Site - Camp Hill, Pennsylvania, United States
- Enveda Investigative Site - Arlington, Texas, United States
- Enveda Investigative Site - Houston, Texas, United States
- Enveda Investigative Site - San Antonio, Texas, United States
- Enveda Investigative Site - Norfolk, Virginia, United States