Skip to content

A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506368-14-00
Acronym
SL0046
Enrollment
255
Registered
2023-12-13
Start date
2021-09-07
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic lupus erythematosus (SLE)

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

DRUG-
DRUGPARACETAMOL
DRUGEPINEPHRINE
DRUGDIPHENHYDRAMINE

Sponsors

UCB Biopharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026