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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508191-11-00
Acronym
SL0044
Enrollment
111
Registered
2023-12-08
Start date
2024-11-28
Completion date
Unknown
Last updated
2025-12-23

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

Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48

Detailed description

Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 24, Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 12, Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48, Achievement of LLDAS in ≥50% of post Baseline visits through Week 48, Change from Baseline in SLEDAI-2K at Week 48, Achievement of BILAG 2004 improvement without worsening at Week 48, Change from Baseline in PGA at Week 48, Achievement of SRI 4 response at Week 48, Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flarefree) through Week 48, Time to severe BILAG flare through Week 48, Time to moderate/severe BILAG flare through Week 48, Percentage of participants with treatment-emergent adverse events (TEAEs) during the study, Percentage of participants with serious treatment-emergent adverse events during the study, Percentage of participants with treatment-emergent adverse events of special interest during the study, Percentage of participants with treatment-emergent adverse events of special monitoring during the study

Interventions

DRUG-
DRUGPlacebo matching dapirolizumab pegol and without active substance
DRUGPARACETAMOL
DRUGDIPHENHYDRAMINE
DRUGEPINEPHRINE

Sponsors

UCB Biopharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48

Secondary

MeasureTime frame
Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 24, Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 12, Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48, Achievement of LLDAS in ≥50% of post Baseline visits through Week 48, Change from Baseline in SLEDAI-2K at Week 48, Achievement of BILAG 2004 improvement without worsening at Week 48, Change from Baseline in PGA at Week 48, Achievement of SRI 4 response at Week 48, Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flarefree) through Week 48, Time to severe BILAG flare through Week 48, Time to moderate/severe BILAG flare through Week 48, Percentage of participants with treatment-emergent adverse events (TEAEs) during the study, Percentage of participants with se

Countries

Belgium, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, Spain

Outcome results

None listed

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