At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 321 enrolled
Drug / intervention
DZP +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating DZP and Placebo for Systemic Lupus Erythematosus. Completed, enrolled 321 participants across 177 sites in 25 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesArgentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Mexico, Peru, Philippines, Poland, Romania, Serbia, South Korea, Spain, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedMar 2020
Enrollment StartAug 2020
Primary CompletionMay 2024
Study CompletionJun 2024
TodayJul 2026
First PostedMar 4, 2020
Enrollment StartAug 12, 2020
Primary CompletionMay 22, 2024
Study CompletionJun 4, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.3 years ago
Interventions
DZPdrug
Subjects will receive dapirolizumab pegol at prespecified time-points.
Placeboother
Subjects will receive placebo at prespecified time-points.