Atopic Dermatitis
Conditions
Brief summary
Percent change from baseline in EASI total score at Week 12
Detailed description
Response based on achieving EASI75 (≥75% improvement from baseline) at scheduled time points, Percent change from baseline in EASI total score at scheduled time points other than Week 12, Response based on achieving vIGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at scheduled time points, Response based on achieving ≥4 points of reduction from baseline in weekly averages of Peak Pruritus Numerical Rating Scale (PP-NRS4) at scheduled time points, Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs), and clinically significant changes in laboratory tests, vital signs, and electrocardiograms (ECGs)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in EASI total score at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Response based on achieving EASI75 (≥75% improvement from baseline) at scheduled time points, Percent change from baseline in EASI total score at scheduled time points other than Week 12, Response based on achieving vIGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at scheduled time points, Response based on achieving ≥4 points of reduction from baseline in weekly averages of Peak Pruritus Numerical Rating Scale (PP-NRS4) at scheduled time points, Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs), and clinically significant changes in laboratory tests, vital signs, and electrocardiograms (ECGs) | — |