A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adult Participants with Moderate-to-Severe Atopic Dermatitis

Conditions

Atopic Dermatitis

Brief summary

Percent change from Baseline inEczema Area and Severity Index (EASI) score at Week 12 (Day 85).

Detailed description

1. Incidence and severity of AEs, serious adverse events (SAEs), and AEs leading to treatment discontinuation 2. Observed value, change and percent change from Baseline in clinical laboratory values, and observed value and change from Baseline in electrocardiograms (ECGs), and vital signs, 3. Proportion of participants who reach at least 75% reduction in EASI score from Baseline (EASI-75) at Week 12 4. Proportion of participants who achieve a ≥2-point reduction from Baseline in Validated Global Investigator Assessment Scale for Atopic Dermatitis (vIGA-AD) score and a score of 0 or 1 at Week 12, 5. Change and percent change from Baseline in PatientOriented Eczema Measure (POEM) at Week 12 6. Peak Pruritus Numerical Rating Scale (PP-NRS) response status defined as achieving weekly mean decrease from Baseline of ≥4 points at Week 12

Related papers

No related papers found yet.

Interventions

DRUGENV-294

DRUGENV-294-Placebo

DRUGNA

DRUGtablet

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from Baseline inEczema Area and Severity Index (EASI) score at Week 12 (Day 85).	—

Secondary

Measure	Time frame
1. Incidence and severity of AEs, serious adverse events (SAEs), and AEs leading to treatment discontinuation 2. Observed value, change and percent change from Baseline in clinical laboratory values, and observed value and change from Baseline in electrocardiograms (ECGs), and vital signs, 3. Proportion of participants who reach at least 75% reduction in EASI score from Baseline (EASI-75) at Week 12 4. Proportion of participants who achieve a ≥2-point reduction from Baseline in Validated Global Investigator Assessment Scale for Atopic Dermatitis (vIGA-AD) score and a score of 0 or 1 at Week 12, 5. Change and percent change from Baseline in PatientOriented Eczema Measure (POEM) at Week 12 6. Peak Pruritus Numerical Rating Scale (PP-NRS) response status defined as achieving weekly mean decrease from Baseline of ≥4 points at Week 12	—

Measure

Time frame

1. Incidence and severity of AEs, serious adverse events (SAEs), and AEs leading to treatment discontinuation 2. Observed value, change and percent change from Baseline in clinical laboratory values, and observed value and change from Baseline in electrocardiograms (ECGs), and vital signs, 3. Proportion of participants who reach at least 75% reduction in EASI score from Baseline (EASI-75) at Week 12 4. Proportion of participants who achieve a ≥2-point reduction from Baseline in Validated Global Investigator Assessment Scale for Atopic Dermatitis (vIGA-AD) score and a score of 0 or 1 at Week 12, 5. Change and percent change from Baseline in PatientOriented Eczema Measure (POEM) at Week 12 6. Peak Pruritus Numerical Rating Scale (PP-NRS) response status defined as achieving weekly mean decrease from Baseline of ≥4 points at Week 12

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Outcome results

None listed