Atopic DermatitisPhase 2NCT07643766
A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
A Phase 2 study testing ENV-294 in people with Atopic Dermatitis, run by Enveda Therapeutics at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- 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
- 200 participants
- Where
- 9 sitesUnited States
- Study dates
- 29 Jun 2026to May 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Operations contact
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Enveda Investigative Site
Boca Raton, Florida, 33486
- Recruiting
Enveda Investigative Site
Dallas, Texas, 75230
- Recruiting
Enveda Investigative Site
Encinitas, California, 92024
- Recruiting
Enveda Investigative Site
Indianapolis, Indiana, 46250
- Recruiting
Enveda Investigative Site
Los Angeles, California, 90045
- Recruiting
Enveda Investigative Site
Northridge, California, 91325
- Recruiting
Enveda Investigative Site
Plainfield, Indiana, 46168
- Recruiting
Enveda Investigative Site
San Antonio, Texas, 78213
- Recruiting
Enveda Investigative Site
Sugar Land, Texas, 77479
About this study
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
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.
- Conditions
- Atopic Dermatitis
- 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.
PlaceboOther
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 (Dose 1) | Experimental | Not described Receives: Drug: ENV-294 |
| ENV-294 Treatment Arm (Dose 2) | Experimental | Not described Receives: Drug: ENV-294 |
| ENV-294 Treatment Arm (Dose 3) | Experimental | Not described Receives: Drug: ENV-294 |
| Placebo Arm | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in Eczema Area and Severity Index (EASI) score
Measured: Baseline to Week 12
Secondary outcomes (6)
Incidence of Treatment Emergent Adverse Events
Measured: Baseline to Week 12 and Week 16
EASI-75 Response
Proportion of participants with at least 75% reduction from Baseline in 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
Percent change in Scoring Atopic Dermatitis (SCORAD)
Measured: Baseline to Week 12
Patient-Reported Outcomes
Change in Patient Oriented Eczema Measure (POEM)
Measured: Baseline to Week 12
Patient-Reported Outcomes
Peak Pruritus Numerical Rating Scale (PP-NRS): proportion of participants who achieve weekly mean decrease from Baseline of ≥4 points
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 posted12 Jun 2026
- Study start29 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- 200 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
- NCT07643766
- Sponsor's protocol ID
- ENV-294-202
- Status last verified
- Aug 2026
- First submitted
- 7 Jun 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07643766
- Acronym / sponsor ID
- ENV-294-202
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Enveda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 12 Jun 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ENV-294 Treatment Arm (Dose 1) | Experimental | Drug: ENV-294 |
| ENV-294 Treatment Arm (Dose 2) | Experimental | Drug: ENV-294 |
| ENV-294 Treatment Arm (Dose 3) | Experimental | Drug: ENV-294 |
| Placebo Arm | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Have PP-NRS score ≥4 Screening and Baseline - the baseline score refers to a weekly average.
Key exclusion criteria (7 listed)
- 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.
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 (Dose 1), ENV-294 Treatment Arm (Dose 2), ENV-294 Treatment Arm (Dose 3) |
| 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. | Other | Placebo Arm |
Primary outcome
Percent change in Eczema Area and Severity Index (EASI) score
Time frame: Baseline to Week 12
6 secondary outcomes
Incidence of Treatment Emergent Adverse Events
Time frame: Baseline to Week 12 and Week 16
EASI-75 Response
Time frame: Baseline to Week 12
vIGA Response
Time frame: Baseline to Week 12
Percent change in Scoring Atopic Dermatitis (SCORAD)
Time frame: Baseline to Week 12
Patient-Reported Outcomes
Time frame: Baseline to Week 12
Patient-Reported Outcomes
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 6 Aug 2026.
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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.
9 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, run by Enveda Therapeutics at 9 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 11 inclusion and 7 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 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Percent change in Eczema Area and Severity Index (EASI) score (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 6 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.