Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Atopic Dermatitis (AD)
Спонсор: Enveda Therapeutics
Налично на:
БГ
Обобщение
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
Кой може да участва
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