At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 182 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
- ✓Confirmed clinical diagnosis of Systemic Lupus Erythematosus (SLE) by SLICC classification criteria
- ✓Moderate to severe SLE disease activity
- ✓At least one SLE serologic marker: anti-dsDNA antibodies, low complement, or ANA ≥1:80 with history of anti-dsDNA or anti-ENA positivity
- ✓Currently receiving stable standard-of-care SLE medication
Key exclusion· 8
- ✕Mixed connective tissue disease, scleroderma, or overlap syndromes of SLE
- ✕Severe neuropsychiatric SLE or other neurological symptoms that would prevent protocol completion
- ✕New or worsening Class III or IV lupus nephritis
- ✕Chronic kidney disease stage 3b or greater
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus
In Brief
A Phase 2 clinical trial evaluating Placebo and Dapirolizumab pegol (DZP) for Systemic Lupus Erythematosus (SLE). Completed, enrolled 182 participants across 71 sites in 13 countries.
Detailed Summary
The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus (SLE)
CountriesBulgaria, Chile, Colombia, Germany, Hungary, Mexico, Peru, Poland, Romania, Russia, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJun 2016
First PostedJun 2016
Primary CompletionMay 2018
Study CompletionNov 2018
TodayJul 2026
First PostedJun 17, 2016
Enrollment StartJun 2, 2016
Primary CompletionMay 31, 2018
Study CompletionNov 19, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 10.0 years ago
Interventions
Placebodrug
Solution for infusion, 0,9% saline
Dapirolizumab pegol (DZP)drug
Solution for infusion