Systemic Lupus Erythematosus
Conditions
Keywords
Lupus,, antibody,, B-cell immunotherapy
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard treatments for patients with SLE.
Interventions
DRUGEpratuzumab
360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion
OTHERPlacebo
Intravenous
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* +ANA at screening * BILAG Index B Level Activity in at least 2 body systems/organs * Has SLE by ACR revised criteria (meets,\<4 criteria)
Exclusion criteria
* Active Severe Lupus as defined by BILAG Index Level A in any body system or organ. * Allergy to human antibodies or Murine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual BILAG assessments; | — |
| Physician and patient assessment scores; | — |
| Time-to treatment failure; | — |
| Proportion of patients with complete response or partial response; | — |
| Maintenance of steroid reduction at 24 and 48 weeks; | — |
| Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus; | — |
| Assess epratuzumab on Health-related quality of life | — |
| Successful steroid reduction by weeks 20 and 24; | — |
Countries
Belgium, Brazil, Canada, Czechia, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Outcome results
None listed