Enveda Therapeutics
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
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…
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
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.