A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Participants With Moderately to Severely Active Systemic Lupus Erythematosus
Phase 3
450
about 3.5 years
16+
57 sites in AR, AZ, CA +17
What this study is about
Researchers are testing whether dapirolizumab pegol (DZP), given as an add-on treatment, can improve disease activity in people with moderately to severely active systemic lupus erythematosus. The trial will last for 1287 days and involve approximately 450 participants.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Placebo
- 2.Take DZP
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Secondary: Change from Baseline in FACIT-Fatigue score at Week 48, Change from Baseline in PGA at Week 48, Change from Baseline in SLEDAI-2K at Week 48, Change from Baseline to Week 48 in the FATIGUE-PRO Total score, Percentage of participants with serious treatment-emergent adverse events during the study, Percentage of participants with treatment-emergent adverse events (TEAEs) during the study, Percentage of participants with treatment-emergent adverse events of special interest during the study, Percentage of participants with treatment-emergent adverse events of special monitoring during the study
Immune