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Recruiting
NCT07298395
Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
Conditions: Atopic Dermatitis (AD)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 60
Sponsor: Enveda Therapeutics
Location: Enveda Investigative Site Birmingham Alabama
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 Criteria
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
Source: ClinicalTrials.gov (NCT07298395). StuddyBuddy aggregates publicly available trial information.