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

Enveda Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis (AD)

Treatments: Drug: ENV-294; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07298395

ENV-294-201

Details and patient eligibility

About

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 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 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 ENV-294
• Return to the clinic for the final study visit at approximately week 16

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have chronic atopic dermatitis that was diagnosed at least 12 months prior to the first study visit
• Have had either: (1) a poor response or intolerance to topical treatments for atopic dermatitis (such as corticosteroids) within the past 6 months, as determined by the study doctor, or (2) a poor response to treatments administered by mouth within the past 12 months.
• Use a bland moisturizer at least daily

Exclusion criteria

• Current or recurrent medical conditions that could affect the study drug or study assessments, including but not limited to: cardiovascular, neurological, kidney, liver, gastrointestinal, cancer, autoimmune disease, HIV, hepatitis B, hepatitis C, or psychiatric disorders.
• Any illness that could impact participant safety, clinically significant depression (as determined by the investigator), or active bacterial, fungal, or viral infections.
• Have an ongoing skin condition or large tattoos that would interfere with the clinical assessment, evaluation of atopic dermatitis, or treatment response.
• Have an ongoing clinically significant skin infection or receiving treatment for infection that may interfere with assessment of atopic dermatitis.
• Have clinically significant abnormal clinical laboratory assessments at the first or second study visit as determined by the Investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

ENV-294 Treatment Arm

Experimental group

Description:

ENV-294 will be administered to those participants randomized to the treatment arm.

Treatment:

Drug: ENV-294

Placebo Arm

Placebo Comparator group

Description:

A placebo (matching the appearance of the experimental drug) will be administered to those participants who are randomized to the placebo arm.

Treatment:

Drug: Placebo