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

Sponsor

UCB Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01449071

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Biological: Placebo Biological: Epratuzumab 400 mg Biological: Epratuzumab 1200 mg Biological: Epratuzumab 100 mg Biological: Epratuzumab 600 mg	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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 Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Group	Biological: Placebo Placebo infusions at study weeks 0, 1, 2, and 3.
Experimental: Epratuzumab 600 mg Group	Biological: Epratuzumab 600 mg Epratuzumab 600 mg infusions at study weeks 0, 1, 2, and 3.
Experimental: Epratuzumab 100 mg Group	Biological: Epratuzumab 100 mg Epratuzumab 100 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
Experimental: Epratuzumab 400 mg Group	Biological: Epratuzumab 400 mg Epratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
Experimental: Epratuzumab 1200 mg Group	Biological: Epratuzumab 1200 mg Epratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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