Systemic lupus erythematosus (SLE)
Conditions
Brief summary
1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of serious treatment-emergent adverse events during the study 3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation
Detailed description
1. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24, 2. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52, 3. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104, 4. Achievement of LLDAS at ≥50% of all visits, 5. Achievement of BICLA response at Week 24, 6. Achievement of BICLA response at Week 52, 7. Achievement of BICLA response at Week 104
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of serious treatment-emergent adverse events during the study 3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24, 2. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52, 3. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104, 4. Achievement of LLDAS at ≥50% of all visits, 5. Achievement of BICLA response at Week 24, 6. Achievement of BICLA response at Week 52, 7. Achievement of BICLA response at Week 104 | — |
Countries
Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Romania, Spain