Systemic Lupus Erythematosus
Conditions
Keywords
Lupus, Monoclonal antibody, B-cell immunotherapy, Epratuzumab
Brief summary
The primary objective of the study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general SLE as add on to standard of care treatment during the trial.
Interventions
BIOLOGICALEpratuzumab 1200 mg
Epratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
BIOLOGICALPlacebo
Placebo infusions at study weeks 0, 1, 2, and 3.
BIOLOGICALEpratuzumab 400 mg
Epratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
BIOLOGICALEpratuzumab 100 mg
Epratuzumab 100 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
BIOLOGICALEpratuzumab 600 mg
Epratuzumab 600 mg infusions at study weeks 0, 1, 2, and 3.
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Positive Anti-nuclear Antibody (ANA) at Screening (Visit 1) * Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria * Active moderate to severe SLE activity as demonstrated by British Isles Lupus Assessment Group Index (BILAG) * Active moderate to severe SLE disease as demonstrated by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score on stable SLE treatment
Exclusion criteria
* Subjects who are breastfeeding, pregnant, or plan to become pregnant * Subjects with active, severe SLE disease activity which involves the renal system and active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A * Serious infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration time curve (AUC) | From baseline to 12 weeks | AUC is defined as the area under the plot of plasma concentration of Epratuzumab against time after administration per subject. All measurements taken in the study (at administration day \[day 0, 7, 14, 21\] and the next four days of each administration day and week-4, 6, 8, 10, 12) are used to calculate AUC |
| Half-life (t1/2) | From baseline to 12 weeks | Half-life is defined as the time taken for plasma concentrations of Epratuzumab to decline by one half per subject. All measurements taken in the study (at administration day \[day 0, 7, 14, 21\] and the next four days of each administration day and week-4, 6, 8, 10, 12) are used to calculate Half-life. |
| Maximum plasma Concentration (Cmax) | From Baseline to 12 weeks | Plasma concentration of Epratuzumab for each pharmacokinetics parameter is measured at administration day (day 0, 7, 14, 21) and the next four days of each administration day and week-4, 6, 8, 10, 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of anti-epratuzumab in plasma during administration over 12 weeks | Day 0 (initial administration day) and week 12 (end of the evaluation period) | Blood drawing for anti- epratuzumab is carried out at initial administration day (day 0) and end of the evaluation period (week 12). |
Countries
Japan
Outcome results
None listed