NCT07298395 Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
| NCT ID | NCT07298395 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Enveda Therapeutics |
| Condition | Atopic Dermatitis (AD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-22 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-12-22 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Clinical Operations
✉ env-294.clinicaltrials@enveda.comGurpreet Ahluwalia, PhD
STUDY DIRECTOR
Enveda Therapeutics, Inc.
Frequently Asked Questions
Who can join the NCT07298395 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Atopic Dermatitis (AD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07298395 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07298395 currently recruiting?
Yes, NCT07298395 is actively recruiting participants. Contact the research team at env-294.clinicaltrials@enveda.com for enrollment information.
Where is the NCT07298395 trial being conducted?
This trial is being conducted at Birmingham, United States, Hot Springs, United States, Beverly Hills, United States, Fremont, United States and 11 additional locations.
Who is sponsoring the NCT07298395 clinical trial?
NCT07298395 is sponsored by Enveda Therapeutics. The principal investigator is Gurpreet Ahluwalia, PhD at Enveda Therapeutics, Inc.. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.