Study of ENV-294 in Healthy Adults and in Adults With Moderate-to-Severe Atopic Dermatitis

Enveda Therapeutics

Status and phase

Active, not recruiting

Phase 1

Conditions

Atopic Dermatitis (AD)

Treatments

Drug: ENV-294 Capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT07336940

ENV-294-101

Details and patient eligibility

About

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

Enrollment

16 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Be male or female participants who are 18 to 75 years of age
Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to the first study visit
Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for used atopic dermatitis
Have moderate-to-severe atopic dermatitis, at the first two study visits
Use an emollient (except those containing urea) daily for at least 1 week prior to the first study visit and throughout the study

Exclusion criteria

Have any uncontrolled current or recurrent concomitant illness (eg, hepatitis B surface antigen, hepatitis C virus, or other condition) that could affect the study drug, clinical or laboratory assessments, or could impact participant safety.
Are using any medication (prescription or over-the-counter) that may interfere with the study product safety evaluations within 14-days prior to the second study visit.
Have the presence of any concomitant skin conditions (eg, psoriasis, seborrheic dermatitis) or have large tattoos that would interfere with clinical assessment, evaluation of AD, or treatment response.