ENV-294 for 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

Adults with chronic moderate-to-severe atopic dermatitis will take ENV-294 or a matching placebo once daily for 12 weeks and return for clinic visits every 2 to 4 weeks with a final visit around week 16. The study will measure skin severity and affected area using clinician scales (vIGA, EASI, BSA) and patient-reported itch (PP-NRS), while monitoring adverse events and laboratory tests for safety. Participants will keep daily symptom and dosing diaries to support adherence and outcome collection. Eligibility requires at least 12 months of AD history and prior inadequate response or intolerance to topical therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have chronic atopic dermatitis that was diagnosed at least 12 months prior to the first study visit
* 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
  * BSA ≥10%
  * PP-NRS score of ≥4
* Have had either a poor response or intolerance to topical treatments for atopic dermatitis (such as corticosteroids) within the past 6 months
* Use a bland moisturizer at least daily

Exclusion Criteria:

* Current or recurrent medical conditions that could affect the study drug or study assessments
* Any illness that could impact participant safety or active infections
* Ongoing skin condition or large tattoos that would interfere with clinical assessment
* Clinically significant skin infection requiring treatment
* Clinically significant abnormal laboratory assessments at screening

Where it's running

• Enveda Investigative Site
  Birmingham, Alabama, United States Recruiting
• Enveda Investigative Site
  Hot Springs, Arkansas, United States Recruiting
• Enveda Investigative Site
  Beverly Hills, California, United States Recruiting
• Enveda Investigative Site
  Fremont, California, United States Recruiting
• Enveda Investigative Site
  San Diego, California, United States Recruiting
• Enveda Investigative Site
  San Diego, California, United States Recruiting

Study contacts

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

Similar studies

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

• Roflumilast Cream 0.3% for moderate to severe atopic dermatitis in children, adolescents, and adults

  A cream called roflumilast 0.3% is tested once daily to see if it helps people with moderate to severe atopic dermatitis, compared to a non-medicated cream, across ages 6 and up.

  Recruiting at 4 sites Phase 3 Arcutis Biotherapeutics, Inc. · Birmingham, Alabama and 3 other locations · NCT07916480

• LT-002-158 tablets for moderate-to-severe atopic dermatitis in adults

  This study tests LT-002-158 vs placebo to see if it helps adults with moderate-to-severe atopic dermatitis.

  Recruiting Phase 2 Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. · Hangzhou, Zhejiang · NCT07895615

• PRA-216 for moderate to severe atopic dermatitis: safety and how it works in the body

  This study tests PRA-216 versus placebo to see if it is safe and helps people with moderate to severe atopic dermatitis.

  Recruiting at 6 sites Phase 2 Prana Therapies Inc · Botany, New South Wales and 8 other locations · NCT07810777

• Skin structure in atopic dermatitis patients treated with nemolizumab assessed by reflectance confocal microscopy

  This study tests whether nemolizumab changes skin structure in adults with moderate-to-severe atopic dermatitis using a noninvasive imaging method.

  Recruiting Hôpitaux Drôme Nord · Romans-sur-Isère, Drôme · NCT07730788

• Global Health Look at Atopic Dermatitis

  A worldwide, multicenter study tests how people with atopic dermatitis access care and treat it, using data from routine medical records.

  Recruiting University of Zurich · Zurich · NCT07659756

• Stapokibart Injection for atopic dermatitis in adults

  This study tests Stapokibart Injection in adults with atopic dermatitis to see how safe it is and whether it helps.

  Recruiting Chengdu Kangnuoxing Biopharma,Inc. · Beijing, Beijing Municipality · NCT07544862

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.