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

UCB Biopharma SRL

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.

Eligibility

Age range: 16+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Study participant must be ≥16 years of age, (≥18 years of age for China), unless restricted by local regulation, at the time of signing the Informed Consent form (ICF) * Study participants who have moderate to severe disease activity due to either persisting active systemic lupus erythematosus (SLE) or due to an acute worsening of SLE in the scope of frequent relapsing-remitting SLE despite stable standard of care(SOC) medication defined as: a. Diagnosed with SLE at least 24 weeks before the Screening Visit by a qualified physician b. Classified by 2019 SLE European L…

Interventions

Drug
DZP
Study participants will receive dapirolizumab pegol (DZP) at prespecified time-points.
Other
Placebo
Study participants will receive placebo at prespecified time-points.

Summary

Eligibility

Interventions

Locations (242)