A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus

Condition(s) studied

Investigational drug(s) / intervention(s)

Dapirolizumab pegol: Subjects will receive dapirolizumab pegol at prespecified time-points.

Study summary

The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.

Eligibility

Primary outcome measure(s)

• Incidence of treatment-emergent adverse events (TEAEs) during the study — 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 — 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 — 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.

Trial sites (119)

+ 79 more sites — see the full list on the official registry below.

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