Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT07298395
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
64 participants
INTERVENTIONAL
2025-12-22
2026-12-31
Brief Summary
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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 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 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 ENV-294
* Return to the clinic for the final study visit at approximately week 16
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ENV-294 Treatment Arm
ENV-294 will be administered to those participants randomized to the treatment arm.
ENV-294
ENV-294 is an orally administered investigational drug supplied as capsules. Each participant will receive ENV-294 at a total dose of 800 milligrams (mg) once daily by mouth for 12 weeks. Capsules should be taken with water, approximately the same time each day, with or without food, as directed by the study physician.
Placebo Arm
A placebo (matching the appearance of the experimental drug) will be administered to those participants who are randomized to the placebo arm.
Placebo
Matching oral capsule that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.
Interventions
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ENV-294
ENV-294 is an orally administered investigational drug supplied as capsules. Each participant will receive ENV-294 at a total dose of 800 milligrams (mg) once daily by mouth for 12 weeks. Capsules should be taken with water, approximately the same time each day, with or without food, as directed by the study physician.
Placebo
Matching oral capsule that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.
Eligibility Criteria
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Inclusion Criteria
* Have had either: (1) a poor response or intolerance to topical treatments for atopic dermatitis (such as corticosteroids) within the past 6 months, as determined by the study doctor, or (2) a poor response to treatments administered by mouth within the past 12 months.
* Use a bland moisturizer at least daily
Exclusion Criteria
* Any illness that could impact participant safety, clinically significant depression (as determined by the investigator), or active bacterial, fungal, or viral infections.
* Have an ongoing skin condition or large tattoos that would interfere with the clinical assessment, evaluation of atopic dermatitis, or treatment response.
* Have an ongoing clinically significant skin infection or receiving treatment for infection that may interfere with assessment of atopic dermatitis.
* Have clinically significant abnormal clinical laboratory assessments at the first or second study visit as determined by the Investigator.
18 Years
75 Years
ALL
No
Sponsors
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Enveda Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Gurpreet Ahluwalia, PhD
Role: STUDY_DIRECTOR
Enveda Therapeutics
Locations
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Options Research Group
West Lafayette, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Other Identifiers
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ENV-294-201
Identifier Type: -
Identifier Source: org_study_id