Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Placebo: 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.

Study 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

Primary outcome measure(s)

• To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD) — Baseline to Week 12
  The effectiveness of ENV-294 compared with placebo will be assessed by the percent change in Eczema Area and Severity Index (EASI) score from the start of the study (Baseline) to Week 12 (Day 85). The EASI score measures the extent and severity of atopic dermatitis, with higher scores indicating more severe disease.

Trial sites (32)

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