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Recruiting Phase 2 NCT07298395

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

Phase 2 – studying effectiveness and dosage
Conditions: Atopic Dermatitis (AD)

Sponsor: Enveda Therapeutics

trial.available_in: БГ
Overview
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 participate
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
Interventions
ENV-294
DRUG
Placebo
DRUG
Locations 17
United States (17)
Enveda Investigative Site
Arlington , Texas
Enveda Investigative Site
Auburn Hills , Michigan
Enveda Investigative Site
Birmingham , Alabama
Enveda Investigative Site
Camp Hill , Pennsylvania
Enveda Investigative Site
Canton , Ohio
Enveda Investigative Site
Clinton Township , Michigan
Enveda Investigative Site
Fremont , California
Enveda Investigative Site
Hot Springs , Arkansas
Enveda Investigative Site
Houston , Texas
Enveda Investigative Site
Las Vegas , Nevada
Enveda Investigative Site
Louisville , Kentucky
Enveda Investigative Site
New Albany , Indiana
Enveda Investigative Site
Norfolk , Virginia
Enveda Investigative Site
San Antonio , Texas
Enveda Investigative Site
San Diego , California
Enveda Investigative Site
San Diego , California
Enveda Investigative Site
West Lafayette , Indiana
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
22.12.2025
Completion date
01.12.2026
Registry ID
NCT07298395
Source
clinicaltrials.gov
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