Atoptic Dermatitis
Conditions
Keywords
atopic dermatitis, eczema, itch
Brief summary
This study will evaluate the efficacy and safety of different doses of EVO756 in adults with moderate to severe atopic dermatitis.
Interventions
DRUGEVO756
Dose 1
DRUGPlacebo control
Placebo control
Sponsors
Evommune, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic AD that has been present for ≥6 months * Validated-Investigator's Global Assessment score of ≥3 * EASI of ≥16 * BSA of AD involvement of ≥10%
Exclusion criteria
* Any clinically significant abnormality in laboratory evaluations, physical examinations, vital signs, or ECG at Screening * Use of certain medications * Presence of skin comorbidities or other condition(s) that may interfere with study assessments * Significant AD flare, in the opinion of the Investigator, within 4 weeks prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in Eczema Area and Severity Index (EASI) from Baseline | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in EASI from Baseline | Weeks 2, 4, and 8 |
| Mean changes in EASI from Baseline | Week 2, 4, 8, and 12 |
| Proportion of subjects with EASI-50, EASI-75, and EASI-90 from Baseline | Weeks 2, 4, 8, and 12 |
| Mean and absolute changes in validated Investigator Global Assessment (vIGA) score from Baseline | Weeks 2, 4, 8, and 12 |
| Proportion of subjects achieving a vIGA score of 0,1 with at least a 2-point reduction from Baseline | Weeks 2, 4, 8, and 12 |
| Mean and percentage change from Baseline in the pruritus-NRS score | Weeks 2, 4, 8, and 12 |
| Proportion of subjects achieving a 4-pt reduction in the pruritus-NRS score from Baseline | Week 2, 4, 8, and 12 |
| Mean and percentage changes from Baseline in Body Surface Area (BSA) of affected area | Weeks 2, 4, 8, and 12 |
| Occurrence of treatment emergent adverse events (TEAE) and serious adverse events (SAE) | through Week 14 |
Countries
New Zealand, United States
Outcome results
None listed