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 (23) 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 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
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 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
Locations
United States
Alabama
Enveda Investigative Site
RECRUITING
Birmingham
Arkansas
Enveda Investigative Site
RECRUITING
Hot Springs
California
Enveda Investigative Site
RECRUITING
Beverly Hills
Enveda Investigative Site
RECRUITING
Fremont
Enveda Investigative Site
RECRUITING
San Diego
Enveda Investigative Site
RECRUITING
San Diego
Enveda Investigative Site
RECRUITING
West Hills
Georgia
Enveda Investigative Site
RECRUITING
Atlanta
Indiana
Enveda Investigative Site
RECRUITING
New Albany
Enveda Investigative Site
RECRUITING
West Lafayette
Kentucky
Enveda Investigative Site
RECRUITING
Louisville
Michigan
Enveda Investigative Site
RECRUITING
Auburn Hills
Enveda Investigative Site
RECRUITING
Bay City
Enveda Investigative Site
RECRUITING
Clinton Township
Enveda Investigative Site
RECRUITING
Warren
Nevada
Enveda Investigative Site
RECRUITING
Las Vegas
Ohio
Enveda Investigative Site
RECRUITING
Canton
Enveda Investigative Site
RECRUITING
Mayfield Heights
Pennsylvania
Enveda Investigative Site
RECRUITING
Camp Hill
Texas
Enveda Investigative Site
RECRUITING
Arlington
Enveda Investigative Site
RECRUITING
Houston
Enveda Investigative Site
RECRUITING
San Antonio
Virginia
Enveda Investigative Site
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:60
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 will be administered to those participants randomized to the placebo arm.