Atopic Dermatitis (AD)Phase 1NCT07336940
Study of ENV-294 in Healthy Adults and in Adults With Moderate-to-Severe Atopic Dermatitis
A Phase 1 study testing ENV-294 Capsule in people with Atopic Dermatitis (AD), run by Enveda Therapeutics at 5 sites in United States.
Trial summary
The goal of this clinical trial is to learn about the safety and tolerability of ENV-294 in adults with moderate to severe atopic dermatitis. It may also learn about the changes ENV-294 may have on the severity of atopic dermatitis symptoms. 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 Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Sep 2025to 13 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Be male or female participants who are 18 to 75 years of age
- Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to the first study visit
- Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for used atopic dermatitis
- Have moderate-to-severe atopic dermatitis, at the first two study visits
- Use an emollient (except those containing urea) daily for at least 1 week prior to the first study visit and throughout the study
Who cannot join
- Have any uncontrolled current or recurrent concomitant illness (eg, hepatitis B surface antigen, hepatitis C virus, or other condition) that could affect the study drug, clinical or laboratory assessments, or could impact participant safety.
- Are using any medication (prescription or over-the-counter) that may interfere with the study product safety evaluations within 14-days prior to the second study visit.
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
J & S Studies
College Station, Texas, 77845
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Skin Sciences, PLLC
Louisville, Kentucky, 40217
Virginia Dermatology & Skin Cancer Center
Norfolk, Virginia, 23502
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
About this study
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Escalation, and Food Effect Study of ENV-294 in Healthy Adult Participants With a Phase 1b Extension in Adults With Moderate-To-Severe Atopic Dermatitis
The goal of this clinical trial is to learn about the safety and tolerability of ENV-294 in adults with moderate to severe atopic dermatitis. It may also learn about the changes ENV-294 may have on the severity of atopic dermatitis symptoms.
The main questions it will answer are:
Read more
- Is ENV-294 safe and well tolerated in adults with moderate to severe atopic dermatitis?
- Is there an impact on the severity of atopic dermatitis symptoms when participants take ENV-294? Researchers will review the atopic dermatitis present at the beginning of the study against the atopic dermatitis present at the end of the study.
Participants will:
- Take drug ENV-294 once every day for 28 days
- Visit the clinic weekly for 4 weeks for checkups and tests
- Keep a diary of their symptoms and when they took their study drug ENV-294
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- ENV-294 Capsule
- 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-294 CapsuleDrug
ENV-294 formulated as 200mg capsules for oral administration will be used for this study.
| Study group | Role | What they receive |
|---|---|---|
| Open-label with once per day dosing | Experimental | Not described Receives: Drug: ENV-294 Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of ENV-294 when administered to adult participants with moderate-to-severe atopic dermatitis.
Incidence and severity of adverse events, serious adverse events and adverse events leading to the discontinuation of treatment.
Measured: From enrollment through treatment and the final study visit at approximately day 42.
Incidence of abnormalities in clinical chemistry parameters as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant abnormalities in clinical chemistry parameters will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294.
Measured: Baseline through end of study at approximately Day 42.
To assess the safety and tolerability of ENV-294 when administered to adult participants with moderate-to-severe atopic dermatitis
Incidence of clinically significant changes in physical exam findings after ENV-294 administration.
Measured: From first dose through treatment and the final study visit at approximately day 42.
Incidence of clinically significant changes in systolic blood pressure (mmHg) as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant increases or decreases in systolic blood pressure, measured in millimeters of mercury (mmHg), will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis.
Measured: From first dose through treatment and the final study visit at approximately day 42.
Incidence of clinically significant changes in heart rate (beats per minute) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant changes in heart rate, measured in beats per minute from 12-lead ECG recordings, will be assessed to evaluate the cardiac safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis.
Measured: Baseline through treatment and the final study visit at approximately day 42.
Incidence of abnormalities in hematology parameters as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant abnormalities in hematology parameters (e.g., hemoglobin, hematocrit, red blood cell count, white blood cell count, platelet count) will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294.
Measured: Baseline through the end of the study at approximately Day 42.
Incidence of abnormalities in coagulation parameters as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant abnormalities in coagulation parameters (e.g., PT, aPTT, INR) will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294.
Measured: Baseline through the end of the study at approximately Day 42.
Incidence of abnormalities in urinalysis parameters as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant abnormalities in urinalysis parameters (e.g., specific gravity, protein, glucose, blood, leukocytes) will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294.
Measured: Baseline through the end of the study at approximately Day 42.
Incidence of clinically significant changes in diastolic blood pressure (mmHg) as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant increases or decreases in diastolic blood pressure, measured in millimeters of mercury (mmHg), will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis.
Measured: Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in heart rate as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant changes in heart rate (beats per minute) will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis.
Measured: Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in respiratory rate as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant changes in respiratory rate (breaths per minute) will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis
Measured: Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in body temperature as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant changes in body temperature (°C) will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis.
Measured: Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in RR interval (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant changes in RR interval, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate the cardiac safety and tolerability of ENV-294.
Measured: Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in PR interval (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant changes in PR interval, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate cardiac conduction safety of ENV-294.
Measured: Baseline through the end of the study at approximately Day 42.
Incidence of clinically significant changes in QRS duration (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant changes in QRS duration, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate cardiac conduction safety of ENV-294.
Measured: Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in QT interval (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant changes in QT interval, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate cardiac repolarization safety of ENV-294.
Measured: Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in QTc Bazett (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant changes in QTc Bazett (QT corrected for heart rate using Bazett's formula), measured in milliseconds (ms), will be assessed to evaluate cardiac safety of ENV-294.
Measured: Baseline through treatment and the final study visit (approximately Day 42)
Incidence of clinically significant changes in QTc Fridericia (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
The number of participants with clinically significant changes in QTc Fridericia (QT corrected for heart rate using Fridericia's formula), measured in milliseconds (ms), will be assessed to evaluate cardiac safety of ENV-294.
Measured: From enrollment through treatment and the final study visit (approximately Day 42)
Secondary outcomes (3)
Maximum observed plasma concentration (Cmax) of ENV-294
Maximum observed plasma concentration (Cmax) of ENV-294 will be determined from plasma samples collected at scheduled time points following oral administration to evaluate pharmacokinetic properties.
Measured: Pre and/or post-dose on days 1, 8, 15 and 28, and on day 42.
Time to reach maximum plasma concentration (Tmax) of ENV-294
Time to reach maximum observed plasma concentration (Tmax) of ENV-294 will be determined from plasma concentrations measured at scheduled post-dose time points.
Measured: Pre and/or post-dose on days 1, 8, 15 and 28, and on day 42.
Area under the plasma concentration-time curve from time zero to 24 hours (AUC₀-₂₄h) of ENV-294
Area under the plasma concentration-time curve from time zero to 24 hours (AUC₀-₂₄h) will be calculated from measured plasma concentrations of ENV-294 to assess systemic drug exposure after multiple oral doses.
Measured: Pre and/or post-dose on days 1, 8, 15 and 28, and on day 42.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start10 Sep 2025
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enveda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336940
- Sponsor's protocol ID
- ENV-294-101
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Escalation, and Food Effect Study of ENV-294 in Healthy Adult Participants With a Phase 1b Extension in Adults With Moderate-To-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07336940
- Acronym / sponsor ID
- ENV-294-101
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Enveda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 13 Jan 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.
The goal of this clinical trial is to learn about the safety and tolerability of ENV-294 in adults with moderate to severe atopic dermatitis. It may also learn about the changes ENV-294 may have on the severity of atopic dermatitis symptoms.
The main questions it will answer are:
- Is ENV-294 safe and well tolerated in adults with moderate to severe atopic dermatitis?
- Is there an impact on the severity of atopic dermatitis symptoms when participants take ENV-294? Researchers will review the atopic dermatitis present at the beginning of the study against the atopic dermatitis present at the end of the study.
Participants will:
- Take drug ENV-294 once every day for 28 days
- Visit the clinic weekly for 4 weeks for checkups and tests
- Keep a diary of their symptoms and when they took their study drug ENV-294
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label with once per day dosing | Experimental | Drug: ENV-294 Capsule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be male or female participants who are 18 to 75 years of age
- Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to the first study visit
- Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for used atopic dermatitis
- Have moderate-to-severe atopic dermatitis, at the first two study visits
- Use an emollient (except those containing urea) daily for at least 1 week prior to the first study visit and throughout the study
Key exclusion criteria (3 listed)
- Have any uncontrolled current or recurrent concomitant illness (eg, hepatitis B surface antigen, hepatitis C virus, or other condition) that could affect the study drug, clinical or laboratory assessments, or could impact participant safety.
- Are using any medication (prescription or over-the-counter) that may interfere with the study product safety evaluations within 14-days prior to the second study visit.
- 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.
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-294 CapsuleENV-294 formulated as 200mg capsules for oral administration will be used for this study. | Drug | Open-label with once per day dosing |
Primary outcome
To assess the safety and tolerability of ENV-294 when administered to adult participants with moderate-to-severe atopic dermatitis.
Time frame: From enrollment through treatment and the final study visit at approximately day 42.
Incidence and severity of adverse events, serious adverse events and adverse events leading to the discontinuation of treatment.
Incidence of abnormalities in clinical chemistry parameters as a measure of safety and tolerability of ENV-294.
Time frame: Baseline through end of study at approximately Day 42.
The number of participants with clinically significant abnormalities in clinical chemistry parameters will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294.
To assess the safety and tolerability of ENV-294 when administered to adult participants with moderate-to-severe atopic dermatitis
Time frame: From first dose through treatment and the final study visit at approximately day 42.
Incidence of clinically significant changes in physical exam findings after ENV-294 administration.
Incidence of clinically significant changes in systolic blood pressure (mmHg) as a measure of safety and tolerability of ENV-294.
Time frame: From first dose through treatment and the final study visit at approximately day 42.
The number of participants with clinically significant increases or decreases in systolic blood pressure, measured in millimeters of mercury (mmHg), will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis.
Incidence of clinically significant changes in heart rate (beats per minute) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Time frame: Baseline through treatment and the final study visit at approximately day 42.
The number of participants with clinically significant changes in heart rate, measured in beats per minute from 12-lead ECG recordings, will be assessed to evaluate the cardiac safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis.
Incidence of abnormalities in hematology parameters as a measure of safety and tolerability of ENV-294.
Time frame: Baseline through the end of the study at approximately Day 42.
The number of participants with clinically significant abnormalities in hematology parameters (e.g., hemoglobin, hematocrit, red blood cell count, white blood cell count, platelet count) will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294.
Incidence of abnormalities in coagulation parameters as a measure of safety and tolerability of ENV-294.
Time frame: Baseline through the end of the study at approximately Day 42.
The number of participants with clinically significant abnormalities in coagulation parameters (e.g., PT, aPTT, INR) will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294.
Incidence of abnormalities in urinalysis parameters as a measure of safety and tolerability of ENV-294.
Time frame: Baseline through the end of the study at approximately Day 42.
The number of participants with clinically significant abnormalities in urinalysis parameters (e.g., specific gravity, protein, glucose, blood, leukocytes) will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294.
Incidence of clinically significant changes in diastolic blood pressure (mmHg) as a measure of safety and tolerability of ENV-294.
Time frame: Baseline through treatment and the final study visit (approximately Day 42).
The number of participants with clinically significant increases or decreases in diastolic blood pressure, measured in millimeters of mercury (mmHg), will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis.
Incidence of clinically significant changes in heart rate as a measure of safety and tolerability of ENV-294.
Time frame: Baseline through treatment and the final study visit (approximately Day 42).
The number of participants with clinically significant changes in heart rate (beats per minute) will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis.
Incidence of clinically significant changes in respiratory rate as a measure of safety and tolerability of ENV-294.
Time frame: Baseline through treatment and the final study visit (approximately Day 42).
The number of participants with clinically significant changes in respiratory rate (breaths per minute) will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis
Incidence of clinically significant changes in body temperature as a measure of safety and tolerability of ENV-294.
Time frame: Baseline through treatment and the final study visit (approximately Day 42).
The number of participants with clinically significant changes in body temperature (°C) will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis.
Incidence of clinically significant changes in RR interval (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Time frame: Baseline through treatment and the final study visit (approximately Day 42).
The number of participants with clinically significant changes in RR interval, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate the cardiac safety and tolerability of ENV-294.
Incidence of clinically significant changes in PR interval (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Time frame: Baseline through the end of the study at approximately Day 42.
The number of participants with clinically significant changes in PR interval, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate cardiac conduction safety of ENV-294.
Incidence of clinically significant changes in QRS duration (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Time frame: Baseline through treatment and the final study visit (approximately Day 42).
The number of participants with clinically significant changes in QRS duration, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate cardiac conduction safety of ENV-294.
Incidence of clinically significant changes in QT interval (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Time frame: Baseline through treatment and the final study visit (approximately Day 42).
The number of participants with clinically significant changes in QT interval, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate cardiac repolarization safety of ENV-294.
Incidence of clinically significant changes in QTc Bazett (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Time frame: Baseline through treatment and the final study visit (approximately Day 42)
The number of participants with clinically significant changes in QTc Bazett (QT corrected for heart rate using Bazett's formula), measured in milliseconds (ms), will be assessed to evaluate cardiac safety of ENV-294.
Incidence of clinically significant changes in QTc Fridericia (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Time frame: From enrollment through treatment and the final study visit (approximately Day 42)
The number of participants with clinically significant changes in QTc Fridericia (QT corrected for heart rate using Fridericia's formula), measured in milliseconds (ms), will be assessed to evaluate cardiac safety of ENV-294.
3 secondary outcomes
Maximum observed plasma concentration (Cmax) of ENV-294
Time frame: Pre and/or post-dose on days 1, 8, 15 and 28, and on day 42.
Time to reach maximum plasma concentration (Tmax) of ENV-294
Time frame: Pre and/or post-dose on days 1, 8, 15 and 28, and on day 42.
Area under the plasma concentration-time curve from time zero to 24 hours (AUC₀-₂₄h) of ENV-294
Time frame: Pre and/or post-dose on days 1, 8, 15 and 28, and on day 42.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ENV-294 Capsule in people with Atopic Dermatitis (AD), run by Enveda Therapeutics at 5 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of ENV-294 when administered to adult participants with moderate-to-severe atopic dermatitis. (time frame: From enrollment through treatment and the final study visit at approximately day 42.). The study lists 18 primary outcomes in all. 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 1 Apr 2026.