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
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
- DrugDZP
Study participants will receive dapirolizumab pegol (DZP) at prespecified time-points.
- OtherPlacebo
Study participants will receive placebo at prespecified time-points.
Locations (225)
- Sl0044 50058Avondale, Arizona
- Sl0044 50550Chandler, Arizona
- Sl0044 50713Gilbert, Arizona
- Sl0044 50662Glendale, Arizona
- Sl0044 50052Phoenix, Arizona
- Sl0044 50677Scottsdale, Arizona