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

Phase 2RecruitingNCT07298395

Enveda Therapeutics105 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

105

Conditions

Atopic Dermatitis (AD)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (32)

Enveda Investigative Site

Birmingham, Alabama, United States

RECRUITING

Enveda Investigative Site

Hot Springs, Arkansas, United States

RECRUITING

Enveda Investigative Site

Beverly Hills, California, United States

RECRUITING

Enveda Investigative Site

Fremont, California, United States

Outcomes

Primary Outcomes

To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD)

The effectiveness of ENV-294 compared with placebo will be assessed by the percent change in Eczema Area and Severity Index (EASI) score from the start of the study (Baseline) to Week 12 (Day 85). The EASI score measures the extent and severity of atopic dermatitis, with higher scores indicating more severe disease.