Atopic Dermatitis (AD)Phase 2NCT07298395
Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
A Phase 2 study testing ENV-294 in people with Atopic Dermatitis (AD), run by Enveda Therapeutics at 32 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- ENV-294
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 32 sitesUnited States
- Study dates
- 22 Dec 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Operations contact
32 sites in 1 country
United States32 sites, 32 recruiting
- Recruiting
Enveda Investigative Site
Arlington, Texas, 76011
- Recruiting
Enveda Investigative Site
Atlanta, Georgia, 30327
- Recruiting
Enveda Investigative Site
Auburn Hills, Michigan, 48326
- Recruiting
Enveda Investigative Site
Bay City, Michigan, 48706
- Recruiting
Enveda Investigative Site
Beverly Hills, California, 90212
- Recruiting
Enveda Investigative Site
Birmingham, Alabama, 35244
- Recruiting
Enveda Investigative Site
Camp Hill, Pennsylvania, 17011
- Recruiting
Enveda Investigative Site
Canton, Ohio, 44718
- Recruiting
Enveda Investigative Site
Chicago, Illinois, 60657
- Recruiting
Enveda Investigative Site
Clarksville, Indiana, 47129
- Recruiting
Enveda Investigative Site
Clinton Township, Michigan, 48038
- Recruiting
Enveda Investigative Site
Fort Lauderdale, Florida, 33308
- Recruiting
Enveda Investigative Site
Fremont, California, 94538
- Recruiting
Enveda Investigative Site
Hot Springs, Arkansas, 71913
- Recruiting
Enveda Investigative Site
Houston, Texas, 77004
- Recruiting
Enveda Investigative Site
Las Vegas, Nevada, 89145
- Recruiting
Enveda Investigative Site
Louisville, Kentucky, 40217
- Recruiting
Enveda Investigative Site
Louisville, Kentucky, 40241
- Recruiting
Enveda Investigative Site
Mayfield Heights, Ohio, 44124
- Recruiting
Enveda Investigative Site
Miami, Florida, 33175
- Recruiting
Enveda Investigative Site
Miramar, Florida, 33027
- Recruiting
Enveda Investigative Site
New Albany, Indiana, 47150
- Recruiting
Enveda Investigative Site
New York, New York, 10029
- Recruiting
Enveda Investigative Site
Norfolk, Virginia, 23502
- Recruiting
Enveda Investigative Site
San Antonio, Texas, 78218
- Recruiting
Enveda Investigative Site
San Diego, California, 92121
- Recruiting
Enveda Investigative Site
San Diego, California, 92123
- Recruiting
Enveda Investigative Site
Santa Monica, California, 90403
- Recruiting
Enveda Investigative Site
Warren, Michigan, 48088
- Recruiting
Enveda Investigative Site
West Hills, California, 91307
- Recruiting
Enveda Investigative Site
West Lafayette, Indiana, 47906
- Recruiting
Enveda Investigative Site
Wilmington, North Carolina, 28405
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ENV-294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
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
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- ENV-294, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENV-294Drug
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| ENV-294 Treatment Arm | Experimental | ENV-294 will be administered to those participants randomized to the treatment arm. Receives: Drug: ENV-294 |
| Placebo Arm | Placebo comparator | A placebo will be administered to those participants randomized to the placebo arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD)
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.
Measured: Baseline to Week 12
Secondary outcomes (6)
Incidence and Severity of Adverse Events
Number and seriousness of adverse events (AEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study drug.
Measured: Baseline to Week 12
EASI-75 Response
Percentage of participants with at least 75% reduction from Baseline in Eczema Area and Severity Index (EASI) score.
Measured: Baseline to Week 12
vIGA Response
Proportion of participants who achieve a ≥2-point reduction from Baseline in validated Global Investigator Assessment (vIGA) score and a score of 0 or 1.
Measured: Baseline to Week 12
Patient-Reported Outcomes
Change and percent change in Peak Pruritus Numerical Rating Scale (PP-NRS).
Measured: Baseline to Week 12
Patient-Reported Outcomes
Change and percent change in Patient Oriented Eczema Measure (POEM).
Measured: Baseline to Week 12
Pharmacokinetics of ENV-294
Observed concentration values of ENV-294 at the times blood samples are collected.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start22 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enveda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gurpreet Ahluwalia, PhD, Study director, Enveda Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298395
- Sponsor's protocol ID
- ENV-294-201
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The data include sensitive health information that cannot be fully de-identified under current privacy standards, and the sponsor does not plan to make IPD available outside the study team. Summary results and aggregate data will be shared publicly as required by regulation.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ENV-294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07298395
- Acronym / sponsor ID
- ENV-294-201
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Enveda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENV-294 Treatment Arm | Experimental | Drug: ENV-294ENV-294 will be administered to those participants randomized to the treatment arm. |
| Placebo Arm | Placebo comparator | Drug: PlaceboA placebo will be administered to those participants randomized to the placebo arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENV-294ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks. | Drug | ENV-294 Treatment Arm |
| PlaceboMatching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product. | Drug | Placebo Arm |
Primary outcome
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.
6 secondary outcomes
Incidence and Severity of Adverse Events
Time frame: Baseline to Week 12
EASI-75 Response
Time frame: Baseline to Week 12
vIGA Response
Time frame: Baseline to Week 12
Patient-Reported Outcomes
Time frame: Baseline to Week 12
Patient-Reported Outcomes
Time frame: Baseline to Week 12
Pharmacokinetics of ENV-294
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The data include sensitive health information that cannot be fully de-identified under current privacy standards, and the sponsor does not plan to make IPD available outside the study team. Summary results and aggregate data will be shared publicly as required by regulation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Operations contact
Gurpreet Ahluwalia, PhD study director
Enveda Therapeutics, Inc.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ENV-294 in people with Atopic Dermatitis (AD), run by Enveda Therapeutics at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations (env-294.clinicaltrials@enveda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD) (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.