Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis (AD)

In brief

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

Key facts

Study ID

NCT07298395

Run by

Enveda Therapeutics

People needed

60

Starts

2025-12-22

Expected to finish

2026-12-01

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Enveda Investigative Site — Birmingham, Alabama, United States (enrolling)
• Enveda Investigative Site — Hot Springs, Arkansas, United States (enrolling)
• Enveda Investigative Site — Beverly Hills, California, United States (enrolling)
• Enveda Investigative Site — Fremont, California, United States (enrolling)
• Enveda Investigative Site — San Diego, California, United States (enrolling)
• Enveda Investigative Site — San Diego, California, United States (enrolling)
• Enveda Investigative Site — Santa Monica, California, United States (enrolling)
• Enveda Investigative Site — West Hills, California, United States (enrolling)
• Enveda Investigative Site — Fort Lauderdale, Florida, United States (enrolling)
• Enveda Investigative Site — Miami, Florida, United States (enrolling)
• Enveda Investigative Site — Miramar, Florida, United States (enrolling)
• Enveda Investigative Site — Atlanta, Georgia, United States (enrolling)
• Enveda Investigative Site — Chicago, Illinois, United States (enrolling)
• Enveda Investigative Site — Clarksville, Indiana, United States (enrolling)
• Enveda Investigative Site — New Albany, Indiana, United States (enrolling)
• Enveda Investigative Site — West Lafayette, Indiana, United States (enrolling)
• Enveda Investigative Site — Louisville, Kentucky, United States (enrolling)
• Enveda Investigative Site — Louisville, Kentucky, United States (enrolling)
• Enveda Investigative Site — Auburn Hills, Michigan, United States (enrolling)
• Enveda Investigative Site — Bay City, Michigan, United States (enrolling)
• Enveda Investigative Site — Clinton Township, Michigan, United States (enrolling)
• Enveda Investigative Site — Warren, Michigan, United States (enrolling)
• Enveda Investigative Site — Las Vegas, Nevada, United States (enrolling)
• Enveda Investigative Site — New York, New York, United States (enrolling)
• Enveda Investigative Site — Wilmington, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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