This double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of ENV-294 in adults with moderate-to-severe atopic dermatitis (AD). The study will compare three dose levels of ENV-294 with placebo administered for 12 weeks. Participants will undergo screening, receive study treatment, and complete scheduled assessments of disease activity, symptoms, quality of life, safety, pharmacokinetics, and biomarker responses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
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.
Enveda Investigative Site
Encinitas, California, United States
RECRUITINGEnveda Investigative Site
Los Angeles, California, United States
RECRUITINGEnveda Investigative Site
Northridge, California, United States
RECRUITINGEnveda Investigative Site
Boca Raton, Florida, United States
RECRUITINGEnveda Investigative Site
Indianapolis, Indiana, United States
RECRUITINGEnveda Investigative Site
Plainfield, Indiana, United States
RECRUITINGEnveda Investigative Site
Dallas, Texas, United States
RECRUITINGEnveda Investigative Site
San Antonio, Texas, United States
RECRUITINGEnveda Investigative Site
Sugar Land, Texas, United States
RECRUITINGPercent change in Eczema Area and Severity Index (EASI) score
Time frame: Baseline to Week 12
Incidence of Treatment Emergent Adverse Events
Time frame: Baseline to Week 12 and Week 16
EASI-75 Response
Proportion of participants with at least 75% reduction from Baseline in EASI score
Time frame: Baseline to Week 12
vIGA Response
Proportion of participants who achieve a ≥2-point reduction from Baseline in validated Global Investigator Assessment (vIGA) score and a score of 0 or 1.
Time frame: Baseline to Week 12
Percent change in Scoring Atopic Dermatitis (SCORAD)
Time frame: Baseline to Week 12
Patient-Reported Outcomes
Change in Patient Oriented Eczema Measure (POEM)
Time frame: Baseline to Week 12
Patient-Reported Outcomes
Peak Pruritus Numerical Rating Scale (PP-NRS): proportion of participants who achieve weekly mean decrease from Baseline of ≥4 points
Time frame: Baseline to Week 12
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