A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
Eligible age
18+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
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About this study
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.
Sponsor: Enveda Therapeutics
You may qualify if…
- ✓ In order to participate in this study all participants must:
- ✓ 1. Be at least 18 years of age at the time of signing the ICF.
- ✓ 2. Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to Screening.
- ✓ 3. 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.
- ✓ 4. Have moderate-to-severe AD, at Screening and Baseline, as defined by the following criteria:
- ✓ 1. A vIGA score of 3 (moderate) or 4 (severe)
- ✓ 2. EASI score of ≥16
- ✓ 3. Body surface area involvement of ≥10%
You may not qualify if…
- ✕ Participants are excluded if they:
- ✕ 1. 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.
- ✕ 2. Have clinically significant abnormalities in any of the clinical laboratory evaluations at Screening or Baseline as determined by the Investigator.
- ✕ 3. 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.
- ✕ 4. 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.
- ✕ 5. 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.
- ✕ 6. Are taking or have taken any prespecified prohibited therapies within a specific timeframe as determined by the Investigator.
Where it's recruiting
Encinitas · Los Angeles · Northridge
Boca Raton
Indianapolis · Plainfield
Dallas · San Antonio · Sugar Land
Source: ClinicalTrials.gov · NCT07643766 · last updated 2026-08-06