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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Enveda Therapeutics
Study ID
NCT07298395
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Atopic Dermatitis (AD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
Dec 22, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ENV-294 Treatment Arm
    ENV-294 will be administered to those participants randomized to the treatment arm.
  • Placebo Comparator: Placebo Arm
    A placebo will be administered to those participants randomized to the placebo arm.

Primary Outcome Measure

To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD) [ Time Frame: Baseline to Week 12 ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
Enveda Investigative SiteBirminghamAlabama35244-
Enveda Investigative SiteHot SpringsArkansas71913-
Enveda Investigative SiteBeverly HillsCalifornia90212-
Enveda Investigative SiteFremontCalifornia94538-
Enveda Investigative SiteSan DiegoCalifornia92121-
Enveda Investigative SiteSan DiegoCalifornia92123-
Enveda Investigative SiteWest HillsCalifornia91307-
Enveda Investigative SiteAtlantaGeorgia30327-
Enveda Investigative SiteNew AlbanyIndiana47150-
Enveda Investigative SiteWest LafayetteIndiana47906-
Enveda Investigative SiteLouisvilleKentucky40217-
Enveda Investigative SiteAuburn HillsMichigan48326-
Enveda Investigative SiteBay CityMichigan48706-
Enveda Investigative SiteClinton TownshipMichigan48038-
Enveda Investigative SiteWarrenMichigan48088-
Enveda Investigative SiteLas VegasNevada89145-
Enveda Investigative SiteCantonOhio44718-
Enveda Investigative SiteMayfield HeightsOhio44124-
Enveda Investigative SiteCamp HillPennsylvania17011-
Enveda Investigative SiteArlingtonTexas76011-
Enveda Investigative SiteHoustonTexas77004-
Enveda Investigative SiteSan AntonioTexas78218-
Enveda Investigative SiteNorfolkVirginia23502-

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