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New treatment option for Atopic Dermatitis (AD)
Official title Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT07298395
What this study is testing
What is ENV-294?
ENV-294 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for atopic dermatitis (ad).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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%
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Hot Springs, Arkansas, United States
- Beverly Hills, California, United States
- Fremont, California, United States
- San Diego, California, United States
- West Hills, California, United States
- Atlanta, Georgia, United States
- New Albany, Indiana, United States
- West Lafayette, Indiana, United States
- Louisville, Kentucky, United States
- Auburn Hills, Michigan, United States
- Bay City, Michigan, United States
- Clinton Township, Michigan, United States
- Warren, Michigan, United States
- Las Vegas, Nevada, United States
- Canton, Ohio, United States
- Mayfield Heights, Ohio, United States
- Camp Hill, Pennsylvania, United States
- Arlington, Texas, United States
- Houston, Texas, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Hot Springs, Arkansas, United States; Beverly Hills, California, United States; Fremont, California, United States; San Diego, California, United States; West Hills, California, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.