Atopic, Dermatitis
Conditions
Brief summary
"Incidence of: • Adverse events (AEs) and discontinuation from study treatment due to AEs. • Serious adverse events (SAEs) and adverse events of special interest (AESI).
Detailed description
Achieving a response (for binary endpoints) at Weeks 16, 32, 48 and every 48 weeks thereafter: • IGA score of 0 or 1 • EASI Reduction of ≥75% from Baseline* • PP-NRS Reduction of ≥4 points, Achieving a maintained response (for binary endpoints) for at least 16/32/48 and every 48 weeks thereafter after first response in: • IGA score of 0 or 1 • EASI Reduction of ≥75% from Baseline* PCFB in the EASI (continuous endpoint) at weeks 16, 32, 48 and every 48 weeks thereafter.
Interventions
Sponsors
Glaxosmithkline Research & Development Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| "Incidence of: • Adverse events (AEs) and discontinuation from study treatment due to AEs. • Serious adverse events (SAEs) and adverse events of special interest (AESI). | — |
Secondary
| Measure | Time frame |
|---|---|
| Achieving a response (for binary endpoints) at Weeks 16, 32, 48 and every 48 weeks thereafter: • IGA score of 0 or 1 • EASI Reduction of ≥75% from Baseline* • PP-NRS Reduction of ≥4 points, Achieving a maintained response (for binary endpoints) for at least 16/32/48 and every 48 weeks thereafter after first response in: • IGA score of 0 or 1 • EASI Reduction of ≥75% from Baseline* PCFB in the EASI (continuous endpoint) at weeks 16, 32, 48 and every 48 weeks thereafter. | — |
Countries
Bulgaria, Czechia, France, Germany, Greece, Italy, Poland, Spain
Outcome results
None listed