A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ENV-294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Enveda Therapeutics
Summary
The goal of this clinical trial is to learn about the safety and effectiveness of ENV-294 in adults with moderate to severe atopic dermatitis. The main questions it will answer are: * Is there an impact on the severity and area of atopic dermatitis when participants take ENV-294 * What medical problems do participants have when taking ENV-294 Participants will: * Take drug ENV-294 or a placebo once every day for 12 weeks * Visit the clinic every 2 to 4 weeks for checkups and tests * Keep a diary of their symptoms and when they took their study drug * Return to the clinic for the final study visit at approximately week 16
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 d…
Interventions
- DrugENV-294
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
- DrugPlacebo
Matching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.
Locations (17)
- Enveda Investigative SiteBirmingham, Alabama
- Enveda Investigative SiteHot Springs, Arkansas
- Enveda Investigative SiteFremont, California
- Enveda Investigative SiteSan Diego, California
- Enveda Investigative SiteSan Diego, California
- Enveda Investigative SiteNew Albany, Indiana