Env-294 in adults with moderate-to-severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2b, double-blind, placebo-controlled trial to evaluate the safety and efficacy of ENV-294 in adults with moderate-to-severe atopic dermatitis. Participants are randomized to three dose levels of ENV-294 or placebo for 12 weeks, with assessments of disease activity, symptoms, quality of life, safety, pharmacokinetics, and biomarkers. Key eligibility includes adults 18+, documented chronic AD, inadequate response to topical or systemic therapies, and objective measures such as vIGA, EASI, and body surface area involvement. Emollient use is required throughout the study. The sponsor is Enveda Therapeutics, with multiple investigative sites in California.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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%
5. Have PP-NRS score ≥4 Screening and Baseline - the baseline score refers to a weekly average.
6. 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.
7. Participants of reproductive potential (male and female participants) must practice effective methods of contraception as per protocol.

Exclusion Criteria:

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 running

• Enveda Investigative Site
  Encinitas, California, United States Recruiting
• Enveda Investigative Site
  Los Angeles, California, United States Recruiting
• Enveda Investigative Site
  Northridge, California, United States Recruiting
• Enveda Investigative Site
  Boca Raton, Florida, United States Recruiting
• Enveda Investigative Site
  Indianapolis, Indiana, United States Recruiting
• Enveda Investigative Site
  Plainfield, Indiana, United States Recruiting

Study contacts

• Study coordinator: Clinical Operations
• Email: env-294.clinicaltrials@enveda.com

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.