NCT07643766 · Enveda Therapeutics
A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
What this study is about
This where neither patients nor doctors know which treatment is given, compared against an inactive treatment study is designed to evaluate the safety and effectiveness of ENV-294 in adults with moderate-to-severe atopic dermatitis (AD). The study will compare three dose levels of ENV-294 with placebo administered for 12 weeks.
View original scientific description
This double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of ENV-294 in adults with moderate-to-severe atopic dermatitis (AD). The study will compare three dose levels of ENV-294 with placebo administered for 12 weeks. Participants will undergo screening, receive study treatment, and complete scheduled assessments of disease activity, symptoms, quality of life, safety, pharmacokinetics, and biomarker responses.
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.
OTHER
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
Percent change in Eczema Area and Severity Index (EASI) score
Time frame: Baseline to Week 12
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
- In order to participate in this study all participants must:
- Be at least 18 years of age at the time of signing the ICF.
- Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to Screening.
- Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for AD within 6 months before Screening and/or inadequate response to a systemic therapy within 12 months before Screening.
- 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
- Body surface area involvement of ≥10%
- Have PP-NRS score ≥4 Screening and Baseline - the baseline score refers to a weekly average.
- Use a bland emollient daily for at least 1 week prior to Day 1 and agree to continue using that same emollient daily at the same frequency (minimally, once daily) throughout the study.
- Participants of reproductive potential (male and female participants) must practice effective methods of contraception as per protocol.
Exclusion criteria
- Participants are excluded if they:
- Have any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
- Have clinically significant abnormalities in any of the clinical laboratory evaluations at Screening or Baseline as determined by the Investigator.
- Have the presence of any concomitant skin conditions (eg, psoriasis, seborrheic dermatitis) or have large tattoos that would interfere with clinical assessment, evaluation of AD, or treatment response as determined by the investigator.
- Have an ongoing clinically significant skin infection or is receiving treatment for infection that may interfere with assessment of AD as determined by the investigator.
- Are pregnant or breastfeeding or are planning to become pregnant during the duration of the study and for 90 days after the last administration of study drug.
- Are taking or have taken any prespecified prohibited therapies within a specific timeframe as determined by the Investigator.
Where
- Encinitas, California
- Los Angeles, California
- Northridge, California
- Boca Raton, Florida
- Indianapolis, Indiana
- Plainfield, Indiana
- Dallas, Texas
- San Antonio, Texas
- Sugar Land, Texas
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 Aug 6, 2026 · Source of record for eligibility and locations