Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)

UCB Pharma20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

PlaceboBIOLOGICAL

Placebo infusions at study weeks 0, 1, 2, and 3.

Epratuzumab 400 mgBIOLOGICAL

Epratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.

Epratuzumab 1200 mgBIOLOGICAL

Epratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (7)

Fukuoka, Japan

Kitakyushu, Japan

Tokyo, Japan

Outcomes

Primary Outcomes

Area under the concentration time curve (AUC)

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

Time frame: From baseline to 12 weeks

Half-life (t1/2)

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.

Time frame: From baseline to 12 weeks

Maximum plasma Concentration (Cmax)

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.

Time frame: From Baseline to 12 weeks

Secondary Outcomes

Incidence of anti-epratuzumab in plasma during administration over 12 weeks

Blood drawing for anti- epratuzumab is carried out at initial administration day (day 0) and end of the evaluation period (week 12).

Time frame: Day 0 (initial administration day) and week 12 (end of the evaluation period)

Data from ClinicalTrials.gov

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