Moderate to Severe Atopic Dermatitis
Conditions
Brief summary
Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest, Part B only: Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 14 for ADX-914 (Part B dose selected) vs placebo
Detailed description
Mean percentage change from baseline in EASI score at Weeks 4, 8, 12, 16, and 24, Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score at Weeks 4, 8, 12, 14, 16, and 24, Proportion of subjects achieving EASI 50, 75 and 90 at Weeks 4, 8, 12, 14, 16, and 24, Proportion of subjects achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with at least 2 grades of reduction from Baseline at Weeks 4, 8, 12, 14, 16, and 24, Part A and B: Safety of ADX-914 in the AD population as evaluated by adverse events (AEs), laboratory evaluations, physical examinations, vital signs, and 12-lead electrocardiogram (ECG)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest, Part B only: Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 14 for ADX-914 (Part B dose selected) vs placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean percentage change from baseline in EASI score at Weeks 4, 8, 12, 16, and 24, Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score at Weeks 4, 8, 12, 14, 16, and 24, Proportion of subjects achieving EASI 50, 75 and 90 at Weeks 4, 8, 12, 14, 16, and 24, Proportion of subjects achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with at least 2 grades of reduction from Baseline at Weeks 4, 8, 12, 14, 16, and 24, Part A and B: Safety of ADX-914 in the AD population as evaluated by adverse events (AEs), laboratory evaluations, physical examinations, vital signs, and 12-lead electrocardiogram (ECG) | — |
Countries
Poland