A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ENV 294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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 Researchers will review the atopic dermatitis present at the beginning of the study against the atopic dermatitis present at the end of the study. 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 ENV-294 * Return to the clinic for the final study visit at approximately week 16
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Have chronic atopic dermatitis that was diagnosed at least 12 months prior to the first study visit
• Have had either: (1) a poor response or intolerance to topical treatments for atopic dermatitis (such as corticosteroids) within the past 6 months, as determined by the study doctor, or (2) a poor response to treatments administered by mouth within the past 12 months.
• Use a bland moisturizer at least daily
Locations
United States
Alabama
Cahaba & Skin Health Center
RECRUITING
Birmingham
Arkansas
Burke Pharmaceutical Research
RECRUITING
Hot Springs
California
Center for Dermatology Clinical Research
RECRUITING
Fremont
Dermatology Cosmetic Laser Associates of La Jolla
RECRUITING
San Diego
TCR Medical Corporation
RECRUITING
San Diego
Indiana
Southern Indiana Clinical Trials
RECRUITING
New Albany
Options Research Group
RECRUITING
West Lafayette
Kentucky
Skin Sciences
RECRUITING
Louisville
Michigan
Oakland Hills Dermatology
RECRUITING
Auburn Hills
Michigan Center for Skin Care Research
RECRUITING
Clinton Township
Nevada
JDR Dermatology Research
RECRUITING
Las Vegas
Ohio
Apex Clinical Research Center
RECRUITING
Canton
Pennsylvania
Best Skin Research
RECRUITING
Camp Hill
Texas
Arlington Research Center
RECRUITING
Arlington
Center for Clinical Studies
RECRUITING
Houston
Texas Dermatology and Laser Specialists
RECRUITING
San Antonio
Virginia
Virginia Dermatology & Skin Cancer Center
RECRUITING
Norfolk
Contact Information
Primary
Clinical Operations
env-294.clinicaltrials@enveda.com
Time Frame
Start Date:2025-12-22
Estimated Completion Date:2026-12
Participants
Target number of participants:64
Treatments
Experimental: ENV-294 Treatment Arm
ENV-294 will be administered to those participants randomized to the treatment arm.
Placebo_comparator: Placebo Arm
A placebo (matching the appearance of the experimental drug) will be administered to those participants who are randomized to the placebo arm.