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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Enveda Therapeutics • ClinicalTrials.gov ID: NCT07298395

Registry updated: 2026-09-25
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Description

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

Interventions

  • ENV-294 (Drug)
    ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
  • Placebo (Drug)
    Matching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.

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

Conditions

Atopic Dermatitis (AD)

Locations

  • Enveda Investigative Site — Birmingham, Alabama, United States
  • Enveda Investigative Site — Hot Springs, Arkansas, United States
  • Enveda Investigative Site — Beverly Hills, California, United States
  • Enveda Investigative Site — Fremont, California, United States
  • Enveda Investigative Site — San Diego, California, United States
  • Enveda Investigative Site — San Diego, California, United States
  • Enveda Investigative Site — Santa Monica, California, United States
  • Enveda Investigative Site — West Hills, California, United States
  • Enveda Investigative Site — Fort Lauderdale, Florida, United States
  • Enveda Investigative Site — Miami, Florida, United States
  • Enveda Investigative Site — Miramar, Florida, United States
  • Enveda Investigative Site — Atlanta, Georgia, United States
  • Enveda Investigative Site — Chicago, Illinois, United States
  • Enveda Investigative Site — Clarksville, Indiana, United States
  • Enveda Investigative Site — New Albany, Indiana, United States
  • Enveda Investigative Site — West Lafayette, Indiana, United States
  • Enveda Investigative Site — Louisville, Kentucky, United States
  • Enveda Investigative Site — Louisville, Kentucky, United States
  • Enveda Investigative Site — Auburn Hills, Michigan, United States
  • Enveda Investigative Site — Bay City, Michigan, United States
  • Enveda Investigative Site — Clinton Township, Michigan, United States
  • Enveda Investigative Site — Warren, Michigan, United States
  • Enveda Investigative Site — Las Vegas, Nevada, United States
  • Enveda Investigative Site — New York, New York, United States
  • Enveda Investigative Site — Wilmington, North Carolina, United States
  • Enveda Investigative Site — Canton, Ohio, United States
  • Enveda Investigative Site — Mayfield Heights, Ohio, United States
  • Enveda Investigative Site — Camp Hill, Pennsylvania, United States
  • Enveda Investigative Site — Arlington, Texas, United States
  • Enveda Investigative Site — Houston, Texas, United States
  • Enveda Investigative Site — San Antonio, Texas, United States
  • Enveda Investigative Site — Norfolk, Virginia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record