Fact CheckerSign in

NCT07336940CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 1 Apr 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
9 (actual)
First submitted
20 Sept 2025
Start date
10 Sept 2025
Primary completion date
13 Jan 2026
Lead sponsor
Enveda Therapeutics
NCT number
NCT07336940

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 9
  • From 10 Sept 2025 to the primary completion date, 13 Jan 2026
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Lab values

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
J&S Studies
Coordinator of this site? Confirm its status
College StationUnited StatesUnknown status
Center For Dermatology Clinical Research, Inc.
Coordinator of this site? Confirm its status
FremontUnited StatesUnknown status
Skin Sciences, PLLC
Coordinator of this site? Confirm its status
LouisvilleUnited StatesUnknown status
Virginia Dermatology & Skin Cancer Center
Coordinator of this site? Confirm its status
NorfolkUnited StatesUnknown status
Texas Dermatology and Laser Specialists
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.