A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis (NCT07643766)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (7 items).
Location: Enveda Investigative Site โ Encinitas, California
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Participants are excluded if they:
- 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.
- 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.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (9 Sites)
- Enveda Investigative Site โ Encinitas, California
- Enveda Investigative Site โ Los Angeles, California
- Enveda Investigative Site โ Northridge, California
- Enveda Investigative Site โ Boca Raton, Florida
- Enveda Investigative Site โ Indianapolis, Indiana
- Enveda Investigative Site โ Plainfield, Indiana
- Enveda Investigative Site โ Dallas, Texas
- Enveda Investigative Site โ San Antonio, Texas
- Enveda Investigative Site โ Sugar Land, Texas
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.