Neurodermatitis
Conditions
Brief summary
Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24
Detailed description
Change in weekly average of daily WI-NRS from baseline to Week 24, Change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24, Change in ItchyQoL score from baseline to Week 24, Change in DLQI total score from baseline to Week 24, Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12, Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab, Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
Interventions
DRUGDupilumab
Sponsors
Sanofi-Aventis Recherche & Developpement
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in weekly average of daily WI-NRS from baseline to Week 24, Change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24, Change in ItchyQoL score from baseline to Week 24, Change in DLQI total score from baseline to Week 24, Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12, Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab, Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) | — |
Countries
Belgium, Czechia, Germany, Greece, Hungary, Italy, Spain
Outcome results
None listed