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
Overview
- Phase
- Phase 3
- Intervention
- Dapirolizumab pegol
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- UCB Biopharma SRL
- Enrollment
- 760
- Locations
- 185
- Primary Endpoint
- Incidence of treatment-emergent adverse events (TEAEs) during the study
- Status
- Enrolling By Invitation
- Last Updated
- yesterday
Overview
Brief Summary
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The participant could, in the opinion of the Investigator, benefit from long-term dapirolizumab pegol (DZP) treatment
- •The participant completed one of the parent studies within 4 weeks prior to entry to this study
Exclusion Criteria
- •\- Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition or ongoing malignancies at the start of the study
Arms & Interventions
Dapirolizumab pegol
Subjects will receive dapriolizumab pegol throughout the Treatment Period.
Intervention: Dapirolizumab pegol
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events (TEAEs) during the study
Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Incidence of serious treatment-emergent adverse events during the study
Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
A serious treatment-emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalisation or prolongation of existing hospitalisation * Results in persistent disability/incapacity * Is a congenital anomaly or birth defect * Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation
Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, and leading to permanent drug discontinuation whether or not these events are related to study treatment.
Secondary Outcomes
- Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24(Week 24)
- Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52(Week 52)
- Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104(Week 104)
- Achievement of LLDAS at ≥50% of all visits(From Baseline (Day 1) until End of Treatment (Week 104))
- Achievement of BICLA response at Week 24(Week 24)
- Achievement of BICLA response at Week 52(Week 52)
- Achievement of BICLA response at Week 104(Week 104)