NCT07298395 · Enveda Therapeutics
Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
ENV-294
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
DRUG
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.
Primary outcome measures
To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Birmingham, Alabama
- Hot Springs, Arkansas
- Beverly Hills, California
- Fremont, California
- San Diego, California
- Santa Monica, California
- West Hills, California
- Fort Lauderdale, Florida
- Miami, Florida
- Miramar, Florida
- Atlanta, Georgia
- Chicago, Illinois
And 18 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 29, 2026 · Source of record for eligibility and locations