Systemic Lupus Erythematosus
Conditions
Keywords
Lupus,, Antibody,, B-Cell immunotherapy
Brief summary
Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments
Interventions
DRUGEpratuzumab
Sponsors
UCB Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have completed SL0003 Alleviate A through 48 weeks
Exclusion criteria
* Development of toxicity to Epratuzumab * Significant protocol deviations from SL0003 Study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE. | — |
Secondary
| Measure | Time frame |
|---|---|
| To continue to assess the efficacy and tolerability of epratuzumab; | — |
| To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus; | — |
| To continue to assess epratuzumab on Health-related quality of life in lupus patients; | — |
| To continue to assess disease status as reported by the patient and physician. | — |
Countries
Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, Italy, Netherlands, Slovakia, Spain, United Kingdom, United States
Outcome results
None listed