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

Phase 1

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Biological: Placebo; Biological: Epratuzumab 600 mg; Biological: Epratuzumab 100 mg; Biological: Epratuzumab 400 mg; Biological: Epratuzumab 1200 mg

• Registration Number: NCT01449071
• Lead Sponsor: UCB Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-03
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-01
• Disposition First Submitted: 2014-01-16
• Disposition First Submitted QC: 2014-01-16
• Last Update Submitted: 2014-01-16
• Disposition First Posted: 2014-02-12
• Last Update Posted: 2014-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	-
Epratuzumab 600 mg Group	Epratuzumab 600 mg	-
Epratuzumab 100 mg Group	Epratuzumab 100 mg	-
Epratuzumab 400 mg Group	Epratuzumab 400 mg	-
Epratuzumab 1200 mg Group	Epratuzumab 1200 mg	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (7)

09; 🇯🇵 Fukuoka, Japan

08; 🇯🇵 Tokyo, Japan

10; 🇯🇵 Fukuoka, Japan

11; 🇯🇵 Fukuoka, Japan

03; 🇯🇵 Kitakyushu, Japan

12; 🇯🇵 Urayasu, Japan

01; 🇯🇵 Tokyo, Japan