Testing ENV-294 for Adults With Moderate-to-Severe Atopic Dermatitis
Tests different doses of ENV-294 against placebo in adults with atopic dermatitis.
Plain-language title generated from the registry record
Registry title: A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
Key facts
- Where
- Boca Raton, Dallas, Encinitas, Indianapolis, Los Angeles, Northridge, Plainfield, San Antonio, and Sugar Land, United StatesSee the 9 sites
- Phase
- Phase 2
Where in United States
- Boca RatonBoca Raton, United StatesTaking people
- DallasDallas, United StatesTaking people
- EncinitasEncinitas, United StatesTaking people
- IndianapolisIndianapolis, United StatesTaking people
- Los AngelesLos Angeles, United StatesTaking people
- NorthridgeNorthridge, United StatesTaking people
- PlainfieldPlainfield, United StatesTaking people
- San AntonioSan Antonio, United StatesTaking people
- Sugar LandSugar Land, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Enveda Therapeutics
- Trial code
- NCT07643766
- Record updated
- 6 August 2026
- Original description
This double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of ENV-294 in adults with moderate-to-severe atopic dermatitis (AD). The study will compare three dose levels of ENV-294 with placebo administered for 12 weeks. Participants will undergo screening, receive study treatment, and complete scheduled assessments of disease activity, symptoms, quality of life, safety, pharmacokinetics, and biomarker responses.Read full original descriptionShow less
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
This double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of ENV-294 in adults with moderate-to-severe atopic dermatitis (AD). The study will compare three dose levels of ENV-294 with placebo administered for 12 weeks. Participants will undergo screening, receive study treatment, and complete scheduled assessments of disease activity, symptoms, quality of life, safety, pharmacokinetics, and biomarker responses.
Inclusion: In order to participate in this study all participants must:; Be at least 18 years of age at the time of signing the ICF; Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to Screening; Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for AD within 6 months before Screening and/or inadequate response to a systemic therapy within 12 months before Screening; 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; Body surface area involvement of ≥10%; Have PP-NRS score ≥4 Screening and Baseline - the baseline score refers to a weekly average; Use a bland emollient daily for at least 1 week prior to Day 1 and agree to continue using that same emollient daily at the same frequency (minimally, once daily) throughout the study; Participants of reproductive potential (male and female participants) must practice effective methods of contraception as per protocol.
Exclusion: 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 as determined by the investigator; Have an ongoing clinically significant skin infection or is receiving treatment for infection that may interfere with assessment of AD as determined by the investigator; Are pregnant or breastfeeding or are planning to become pregnant during the duration of the study and for 90 days after the last administration of study drug; Are taking or have taken any prespecified prohibited therapies within a specific timeframe as determined by the Investigator; Have any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results; Have clinically significant abnormalities in any of the clinical laboratory evaluations at Screening or Baseline as determined by the Investigator; Participants are excluded if they:.