ENV-294 for Atopic Dermatitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, ENV-294, to determine its safety and effectiveness for adults with moderate to severe atopic dermatitis, a condition causing itchy and inflamed skin. Researchers aim to discover if ENV-294 can reduce symptom severity. Participants will take the drug daily for 28 days and monitor their symptoms. This trial suits individuals who have had atopic dermatitis for at least a year and find their current treatments, such as topical creams, insufficient. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
You may need to stop taking certain medications that could interfere with the study, as the trial excludes those using medications that might affect safety evaluations within 14 days before the second visit. It's best to discuss your current medications with the study team to see if any changes are needed.
Is there any evidence suggesting that ENV-294 is likely to be safe for humans?
Research has shown that ENV-294 is generally safe. One study found that participants tolerated ENV-294 well at all dose levels. Importantly, no harmful effects prevented dose escalation. Additionally, no serious unexpected medical problems occurred during the study. This evidence suggests that ENV-294 is safe for adults with moderate to severe atopic dermatitis. However, monitoring participants during the trial is crucial to ensure their safety.12345
Why do researchers think this study treatment might be promising?
ENV-294 is unique because it offers a novel approach to treating atopic dermatitis, a condition where current treatments like topical corticosteroids and calcineurin inhibitors are commonly used. Unlike these standard therapies that primarily focus on reducing inflammation and suppressing the immune response, ENV-294 may work through a different mechanism, potentially targeting specific pathways related to the condition. Researchers are excited about this treatment because it could provide a new option for patients who don't respond well to existing treatments or who experience side effects, offering hope for better management of atopic dermatitis.
What evidence suggests that ENV-294 might be an effective treatment for atopic dermatitis?
Research shows that ENV-294 may help treat moderate to severe atopic dermatitis, a type of skin condition. Earlier studies found that ENV-294 was safe, with no serious side effects, indicating a positive safety profile. Initial results also suggested that it could effectively reduce symptoms of atopic dermatitis. The treatment targets specific processes in the body that cause the inflammation and itchiness associated with this condition. While more research is needed, these early findings offer hope for people dealing with atopic dermatitis.12467
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with chronic atopic dermatitis (eczema) diagnosed over a year ago, who haven't responded well to topical treatments. They must have moderate-to-severe symptoms and be willing to use an emollient daily except those with urea.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take drug ENV-294 once every day for 28 days and visit the clinic weekly for checkups and tests
Follow-up
Participants are monitored for safety and effectiveness after treatment
Phase 1b Extension
Extension phase for adults with moderate-to-severe atopic dermatitis to further assess safety and tolerability
What Are the Treatments Tested in This Trial?
Interventions
- ENV-294
Trial Overview
The study tests the safety and effects of ENV-294 on symptom severity in atopic dermatitis. Participants will take ENV-294 capsules daily for 28 days, attend weekly clinic visits for checkups/tests, and keep a diary of symptoms and medication intake.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Enveda Therapeutics
Lead Sponsor
Citations
NCT07298395 | Study of ENV-294 in Adults With Moderate ...
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.
Enveda Initiates Phase 2 Clinical Trials of ENV-294, a First- ...
Advancement to Phase 2 follows positive interim Phase 1b data in Atopic Dermatitis, demonstrating a robust efficacy and safety profile.
NCT07336940 | Study of ENV-294 in Healthy Adults and in ...
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.
Dr. Vince Clinical Research Announces First Dosing in ...
ENV-294 was well-tolerated across all dose levels, with no dose-limiting toxicities or serious adverse events and demonstrated a favorable ...
Enveda Reports Favorable Phase 1 Safety for Novel Oral ...
ENV-294 was found to be well-tolerated with a favorable safety profile across all dose levels, with no dose-limiting toxicities or serious adverse events ...
Enveda Reports Favorable Phase 1 Safety for Novel Oral ...
ENV-294 was found to be well-tolerated with a favorable safety profile across all dose levels, with no dose-limiting toxicities or serious adverse events ...
Enveda Initiates Phase 2 Clinical Trials of ENV-294, a First- ...
Advancement to Phase 2 follows positive interim Phase 1b data in Atopic Dermatitis, demonstrating a robust efficacy and safety profile.
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