NCT06617325

A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	DZP	Study participants will receive dapirolizumab pegol (DZP) at prespecified time-points.
OTHER	Placebo	Study participants will receive placebo at prespecified time-points.

Timeline

• Start date: 2024-11-21
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2024-09-27
• Last updated: 2026-04-03

Locations

219 sites across 22 countries: United States, Argentina, Belgium, Canada, Chile, China, Denmark, France, Germany, Greece, Italy, Japan, Mexico, Netherlands, Peru, Poland, Puerto Rico, Serbia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study