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

Official title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ENV-294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

Overview

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

Interventions

• Drug ENV-294
  ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
• Drug Placebo
  Matching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.

Primary outcome measures

• To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD) [Time frame: Baseline to Week 12]

Secondary outcome measures (6)

• Incidence and Severity of Adverse Events [Time frame: Baseline to Week 12]
• EASI-75 Response [Time frame: Baseline to Week 12]
• vIGA Response [Time frame: Baseline to Week 12]
• Patient-Reported Outcomes [Time frame: Baseline to Week 12]
• Patient-Reported Outcomes [Time frame: Baseline to Week 12]
• Pharmacokinetics of ENV-294 [Time frame: Baseline to Week 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 32 centers

• Enveda Investigative Site — Birmingham
• Enveda Investigative Site — Hot Springs
• Enveda Investigative Site — Beverly Hills
• Enveda Investigative Site — Fremont
• Enveda Investigative Site — San Diego
• Enveda Investigative Site — San Diego
• Enveda Investigative Site — Santa Monica
• Enveda Investigative Site — West Hills
• … and 24 more centers

Identifiers

NCT: NCT07298395 · ENV-294-201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗