64 Participants Needed

ENV-294 for Atopic Dermatitis

CS
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Overseen ByJill Sr. Clinical Trial Manager
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Enveda Therapeutics
Prior Safety DataThis treatment has passed at least one previous human trial

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 effectiveness for individuals with moderate to severe atopic dermatitis, also known as eczema. Researchers aim to assess whether the drug reduces the severity and area of the rash and identify any potential side effects. Participants will take either ENV-294 or a placebo (a pill with no active drug) daily for 12 weeks and will attend regular clinic checkups. The trial seeks individuals who have had atopic dermatitis for at least a year and have not found success with other treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in eczema treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study doctor to understand how your medications might interact with the trial.

Is there any evidence suggesting that ENV-294 is likely to be safe for humans?

Research has shown that ENV-294 has been well-tolerated in earlier studies. One study found that ENV-294 had a good safety record, with participants not experiencing serious health issues. Even at higher doses, no harmful effects or serious side effects were reported. These findings suggest that ENV-294 is likely safe for humans, based on past studies. While more research is needed, these results offer some reassurance about its safety.12345

Why do researchers think this study treatment might be promising?

Most treatments for atopic dermatitis, like topical corticosteroids and calcineurin inhibitors, work by reducing inflammation or suppressing the immune system. But ENV-294 works differently, targeting specific pathways involved in the inflammatory process. This novel mechanism could potentially offer relief with fewer side effects compared to current options. Researchers are excited because this targeted approach might provide more effective management of symptoms, especially for those who haven't responded well to existing treatments.

What evidence suggests that ENV-294 might be an effective treatment for atopic dermatitis?

Research shows that ENV-294, which participants in this trial may receive, may help treat atopic dermatitis, a condition that causes itchy and inflamed skin. Earlier studies found ENV-294 to be safe and effective, with no serious side effects reported. People with atopic dermatitis who used ENV-294 experienced improvements without major issues. These positive results suggest that ENV-294 could reduce the severity and size of the affected skin areas.13678

Who Is on the Research Team?

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Gurpreet Ahluwalia, PhD

Principal Investigator

Enveda Therapeutics

Are You a Good Fit for This Trial?

Adults with moderate to severe atopic dermatitis for over a year, who haven't responded well or are intolerant to standard treatments like topical corticosteroids in the past 6 months, or oral treatments in the past year. Participants must use daily moisturizer.

Inclusion Criteria

I have had chronic atopic dermatitis for over a year.
My skin condition didn't improve with creams or pills as judged by my doctor.
I use a simple moisturizer every day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take drug ENV-294 or a placebo once every day for 12 weeks

12 weeks
Clinic visits every 2 to 4 weeks for checkups and tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
Final study visit at approximately week 16

What Are the Treatments Tested in This Trial?

Interventions

  • ENV-294

Trial Overview

The trial is testing ENV-294's safety and effectiveness against atopic dermatitis compared to a placebo. Over 12 weeks, participants take either ENV-294 or a placebo daily, attend regular clinic visits for checkups and tests, and keep symptom diaries.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ENV-294 Treatment ArmExperimental Treatment1 Intervention
Group II: Placebo ArmPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Enveda Therapeutics

Lead Sponsor

Citations

Study of ENV-294 in Adults With Moderate-to-Severe ...

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.

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 ...

AI-discovered natural eczema medicine advances to ...

The US Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for ENV-294 targeting atopic dermatitis ...

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- ...

The Phase 2a program is designed to evaluate the safety, tolerability, and efficacy of ENV-294 in two distinct patient populations, supporting ...

Study of ENV-294 in Adults With Moderate-to-Severe Atopic ...

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.