Trials / Completed
CompletedNCT04294667
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
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 321 (actual)
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DZP | Subjects will receive dapirolizumab pegol at prespecified time-points. |
| OTHER | Placebo | Subjects will receive placebo at prespecified time-points. |
Timeline
- Start date
- 2020-08-12
- Primary completion
- 2024-05-22
- Completion
- 2024-06-04
- First posted
- 2020-03-04
- Last updated
- 2025-05-04
- Results posted
- 2025-04-24
Locations
177 sites across 25 countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Mexico, Peru, Philippines, Poland, Romania, Serbia, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04294667. Inclusion in this directory is not an endorsement.