NCT04976322

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

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: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 760 (estimated)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Dapirolizumab pegol	Subjects will receive dapirolizumab pegol at prespecified time-points.

Timeline

• Start date: 2021-07-27
• Primary completion: 2030-08-07
• Completion: 2030-08-07
• First posted: 2021-07-26
• Last updated: 2026-04-17

Locations

104 sites across 23 countries: United States, Argentina, Belgium, Bulgaria, Canada, Chile, China, Colombia, Czechia, Germany, Greece, Hungary, Italy, Japan, Mexico, Peru, Philippines, Poland, Romania, Serbia, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study