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.
Full Title of Study: “A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe Disease”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: March 2013
- Biological: Placebo
- Placebo infusions at study weeks 0, 1, 2, and 3.
- Biological: Epratuzumab 400 mg
- Epratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
- Biological: Epratuzumab 1200 mg
- Epratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
- Biological: Epratuzumab 100 mg
- Epratuzumab 100 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
- Biological: Epratuzumab 600 mg
- Epratuzumab 600 mg infusions at study weeks 0, 1, 2, and 3.
Arms, Groups and Cohorts
- Placebo Comparator: Placebo Group
- Experimental: Epratuzumab 600 mg Group
- Experimental: Epratuzumab 100 mg Group
- Experimental: Epratuzumab 400 mg Group
- Experimental: Epratuzumab 1200 mg Group
Clinical Trial Outcome Measures
- Area under the concentration time curve (AUC)
- Time Frame: 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)
- Time Frame: 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)
- Time Frame: 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.
- Incidence of anti-epratuzumab in plasma during administration over 12 weeks
- Time Frame: 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).
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 64 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- UCB Pharma
- Provider of Information About this Clinical Study
- Overall Official(s)
- UCB Clinical Trial Call Center, Study Director, +1 877 822 9493 (UCB)
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