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NCT Number: NCT07298395

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

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

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Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Enveda Investigative Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline to Week 12

    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.

Secondary outcomes

  1. Incidence and Severity of Adverse Events

    Time frame: Baseline to Week 12

    Number and seriousness of adverse events (AEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study drug.

  2. EASI-75 Response

    Time frame: Baseline to Week 12

    Percentage of participants with at least 75% reduction from Baseline in Eczema Area and Severity Index (EASI) score.

  3. vIGA Response

    Time frame: Baseline to Week 12

    Proportion of participants who achieve a ≥2-point reduction from Baseline in validated Global Investigator Assessment (vIGA) score and a score of 0 or 1.

  4. Patient-Reported Outcomes

    Time frame: Baseline to Week 12

    Change and percent change in Peak Pruritus Numerical Rating Scale (PP-NRS).

  5. Patient-Reported Outcomes

    Time frame: Baseline to Week 12

    Change and percent change in Patient Oriented Eczema Measure (POEM).

  6. Pharmacokinetics of ENV-294

    Time frame: Baseline to Week 12

    Observed concentration values of ENV-294 at the times blood samples are collected.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Operations

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Enveda Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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