ENV-294 for Atopic Dermatitis

Not currently recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Enveda Therapeutics

Must be taking: Emollients

Disqualifiers: Hepatitis B, Hepatitis C, Psoriasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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

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

I have had chronic atopic dermatitis for over a year.

I have tried topical treatments for my skin condition without success or could not tolerate them.

I have moderate-to-severe eczema.

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 once every day for 28 days and visit the clinic weekly for checkups and tests

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

Phase 1b Extension

Extension phase for adults with moderate-to-severe atopic dermatitis to further assess safety and tolerability

Long-term

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?

Group I: Open-label with once per day dosing Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Enveda Therapeutics

Lead Sponsor