Atopic Dermatitis
Conditions
Brief summary
Proportion of subjects achieving validated IGA scale for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from baseline at Week 16, Proportion of subjects achieving improvement from baseline of at least 75% on Eczema Area Severity Index (EASI 75) at Week 16.
Detailed description
Proportion of subjects achieving an improvement (reduction) in Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 from Baseline at Week 16 for subjects with Worst Pruritus NRS ≥ 4 at Baseline, Proportion of subjects achieving a 90% reduction in EASI (EASI 90) at Week 16, Percent change from Baseline of Worst Pruritus NRS at Week 16, Percent change in EASI score from Baseline at Week 16., Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS ≥ 4 from Baseline at Week 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline, Proportion of subjects achieving EASI 75 at Week 4, Proportion of subjects achieving EASI 75 at Week 2, Proportion of subjects achieving EASI 90 at Week 4, Proportion of subjects achieving EASI 100 at Week 16 for 30 mg, Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS ≥ 4 from Baseline at Week 1 for subjects with Worst Pruritus NRS ≥ 4 at Baseline.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving validated IGA scale for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from baseline at Week 16, Proportion of subjects achieving improvement from baseline of at least 75% on Eczema Area Severity Index (EASI 75) at Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving an improvement (reduction) in Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 from Baseline at Week 16 for subjects with Worst Pruritus NRS ≥ 4 at Baseline, Proportion of subjects achieving a 90% reduction in EASI (EASI 90) at Week 16, Percent change from Baseline of Worst Pruritus NRS at Week 16, Percent change in EASI score from Baseline at Week 16., Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS ≥ 4 from Baseline at Week 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline, Proportion of subjects achieving EASI 75 at Week 4, Proportion of subjects achieving EASI 75 at Week 2, Proportion of subjects achieving EASI 90 at Week 4, Proportion of subjects achieving EASI 100 at Week 16 for 30 mg, Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS ≥ 4 from Baseline at Week 1 for subjects with Worst Pruritus NRS ≥ 4 at Baseline. | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czechia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden