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

March 31, 2026 updated by: Enveda Therapeutics

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Escalation, and Food Effect Study of ENV-294 in Healthy Adult Participants With a Phase 1b Extension in Adults With Moderate-To-Severe Atopic Dermatitis

The goal of this clinical trial is to learn about the safety and tolerability of ENV-294 in adults with moderate to severe atopic dermatitis. It may also learn about the changes ENV-294 may have on the severity of atopic dermatitis symptoms.

The main questions it will answer are:

  • Is ENV-294 safe and well tolerated in adults with moderate to severe atopic dermatitis?
  • Is there an impact on the severity of atopic dermatitis symptoms when participants take ENV-294? Researchers will review the atopic dermatitis present at the beginning of the study against the atopic dermatitis present at the end of the study.

Participants will:

  • Take drug ENV-294 once every day for 28 days
  • Visit the clinic weekly for 4 weeks for checkups and tests
  • Keep a diary of their symptoms and when they took their study drug ENV-294

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fremont, California, United States, 94538
        • Center For Dermatology Clinical Research, Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Skin Sciences, PLLC
    • Texas
      • College Station, Texas, United States, 77845
        • J & S Studies
      • San Antonio, Texas, United States, 78218
        • Texas Dermatology and Laser Specialists
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Dermatology & Skin Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be male or female participants who are 18 to 75 years of age
  • Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to the first study visit
  • Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for used atopic dermatitis
  • Have moderate-to-severe atopic dermatitis, at the first two study visits
  • Use an emollient (except those containing urea) daily for at least 1 week prior to the first study visit and throughout the study

Exclusion Criteria:

  • Have any uncontrolled current or recurrent concomitant illness (eg, hepatitis B surface antigen, hepatitis C virus, or other condition) that could affect the study drug, clinical or laboratory assessments, or could impact participant safety.
  • Are using any medication (prescription or over-the-counter) that may interfere with the study product safety evaluations within 14-days prior to the second study visit.
  • Have the presence of any concomitant skin conditions (eg, psoriasis, seborrheic dermatitis) or have large tattoos that would interfere with clinical assessment, evaluation of AD, or treatment response.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-label with once per day dosing
Drug: ENV-294 Capsule
ENV-294 formulated as 200mg capsules for oral administration will be used for this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the safety and tolerability of ENV-294 when administered to adult participants with moderate-to-severe atopic dermatitis.
Time Frame: From enrollment through treatment and the final study visit at approximately day 42.
Incidence and severity of adverse events, serious adverse events and adverse events leading to the discontinuation of treatment.
From enrollment through treatment and the final study visit at approximately day 42.
Incidence of abnormalities in clinical chemistry parameters as a measure of safety and tolerability of ENV-294.
Time Frame: Baseline through end of study at approximately Day 42.
The number of participants with clinically significant abnormalities in clinical chemistry parameters will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294.
Baseline through end of study at approximately Day 42.
To assess the safety and tolerability of ENV-294 when administered to adult participants with moderate-to-severe atopic dermatitis
Time Frame: From first dose through treatment and the final study visit at approximately day 42.
Incidence of clinically significant changes in physical exam findings after ENV-294 administration.
From first dose through treatment and the final study visit at approximately day 42.
Incidence of clinically significant changes in systolic blood pressure (mmHg) as a measure of safety and tolerability of ENV-294.
Time Frame: From first dose through treatment and the final study visit at approximately day 42.
The number of participants with clinically significant increases or decreases in systolic blood pressure, measured in millimeters of mercury (mmHg), will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis.
From first dose through treatment and the final study visit at approximately day 42.
Incidence of clinically significant changes in heart rate (beats per minute) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Time Frame: Baseline through treatment and the final study visit at approximately day 42.
The number of participants with clinically significant changes in heart rate, measured in beats per minute from 12-lead ECG recordings, will be assessed to evaluate the cardiac safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis.
Baseline through treatment and the final study visit at approximately day 42.
Incidence of abnormalities in hematology parameters as a measure of safety and tolerability of ENV-294.
Time Frame: Baseline through the end of the study at approximately Day 42.
The number of participants with clinically significant abnormalities in hematology parameters (e.g., hemoglobin, hematocrit, red blood cell count, white blood cell count, platelet count) will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294.
Baseline through the end of the study at approximately Day 42.
Incidence of abnormalities in coagulation parameters as a measure of safety and tolerability of ENV-294.
Time Frame: Baseline through the end of the study at approximately Day 42.
The number of participants with clinically significant abnormalities in coagulation parameters (e.g., PT, aPTT, INR) will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294.
Baseline through the end of the study at approximately Day 42.
Incidence of abnormalities in urinalysis parameters as a measure of safety and tolerability of ENV-294.
Time Frame: Baseline through the end of the study at approximately Day 42.
The number of participants with clinically significant abnormalities in urinalysis parameters (e.g., specific gravity, protein, glucose, blood, leukocytes) will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294.
Baseline through the end of the study at approximately Day 42.
Incidence of clinically significant changes in diastolic blood pressure (mmHg) as a measure of safety and tolerability of ENV-294.
Time Frame: Baseline through treatment and the final study visit (approximately Day 42).
The number of participants with clinically significant increases or decreases in diastolic blood pressure, measured in millimeters of mercury (mmHg), will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis.
Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in heart rate as a measure of safety and tolerability of ENV-294.
Time Frame: Baseline through treatment and the final study visit (approximately Day 42).
The number of participants with clinically significant changes in heart rate (beats per minute) will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis.
Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in respiratory rate as a measure of safety and tolerability of ENV-294.
Time Frame: Baseline through treatment and the final study visit (approximately Day 42).
The number of participants with clinically significant changes in respiratory rate (breaths per minute) will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis
Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in body temperature as a measure of safety and tolerability of ENV-294.
Time Frame: Baseline through treatment and the final study visit (approximately Day 42).
The number of participants with clinically significant changes in body temperature (°C) will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis.
Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in RR interval (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Time Frame: Baseline through treatment and the final study visit (approximately Day 42).
The number of participants with clinically significant changes in RR interval, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate the cardiac safety and tolerability of ENV-294.
Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in PR interval (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Time Frame: Baseline through the end of the study at approximately Day 42.
The number of participants with clinically significant changes in PR interval, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate cardiac conduction safety of ENV-294.
Baseline through the end of the study at approximately Day 42.
Incidence of clinically significant changes in QRS duration (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Time Frame: Baseline through treatment and the final study visit (approximately Day 42).
The number of participants with clinically significant changes in QRS duration, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate cardiac conduction safety of ENV-294.
Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in QT interval (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Time Frame: Baseline through treatment and the final study visit (approximately Day 42).
The number of participants with clinically significant changes in QT interval, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate cardiac repolarization safety of ENV-294.
Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in QTc Bazett (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Time Frame: Baseline through treatment and the final study visit (approximately Day 42)
The number of participants with clinically significant changes in QTc Bazett (QT corrected for heart rate using Bazett's formula), measured in milliseconds (ms), will be assessed to evaluate cardiac safety of ENV-294.
Baseline through treatment and the final study visit (approximately Day 42)
Incidence of clinically significant changes in QTc Fridericia (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Time Frame: From enrollment through treatment and the final study visit (approximately Day 42)
The number of participants with clinically significant changes in QTc Fridericia (QT corrected for heart rate using Fridericia's formula), measured in milliseconds (ms), will be assessed to evaluate cardiac safety of ENV-294.
From enrollment through treatment and the final study visit (approximately Day 42)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum observed plasma concentration (Cmax) of ENV-294
Time Frame: Pre and/or post-dose on days 1, 8, 15 and 28, and on day 42.
Maximum observed plasma concentration (Cmax) of ENV-294 will be determined from plasma samples collected at scheduled time points following oral administration to evaluate pharmacokinetic properties.
Pre and/or post-dose on days 1, 8, 15 and 28, and on day 42.
Time to reach maximum plasma concentration (Tmax) of ENV-294
Time Frame: Pre and/or post-dose on days 1, 8, 15 and 28, and on day 42.
Time to reach maximum observed plasma concentration (Tmax) of ENV-294 will be determined from plasma concentrations measured at scheduled post-dose time points.
Pre and/or post-dose on days 1, 8, 15 and 28, and on day 42.
Area under the plasma concentration-time curve from time zero to 24 hours (AUC₀-₂₄h) of ENV-294
Time Frame: Pre and/or post-dose on days 1, 8, 15 and 28, and on day 42.
Area under the plasma concentration-time curve from time zero to 24 hours (AUC₀-₂₄h) will be calculated from measured plasma concentrations of ENV-294 to assess systemic drug exposure after multiple oral doses.
Pre and/or post-dose on days 1, 8, 15 and 28, and on day 42.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enveda Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2025

Primary Completion (Actual)

January 13, 2026

Study Completion (Actual)

January 13, 2026

Study Registration Dates

First Submitted

September 20, 2025

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENV-294-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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