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

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

Enrollment: 60 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 moderate-to-severe AD at screening and baseline as defined by the following criteria:

  • A vIGA score of 3 (moderate) or 4 (severe)
  • EASI score of ≥16
  • BSA ≥10%
  • PP-NRS score of ≥4

• Have had either a poor response or intolerance to topical treatments for atopic dermatitis (such as corticosteroids) within the past 6 months

• Use a bland moisturizer at least daily

Exclusion criteria

• Current or recurrent medical conditions that could affect the study drug or study assessments
• Any illness that could impact participant safety or active infections
• Ongoing skin condition or large tattoos that would interfere with clinical assessment
• Clinically significant skin infection requiring treatment
• Clinically significant abnormal laboratory assessments at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 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 will be administered to those participants randomized to the placebo arm.

Treatment:

Drug: Placebo