Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)
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
1 other identifier
interventional
20
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2011
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 3, 2011
CompletedFirst Posted
Study publicly available on registry
October 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFebruary 12, 2014
January 1, 2014
1.4 years
October 3, 2011
January 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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.
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.
From Baseline to 12 weeks
Secondary Outcomes (1)
Incidence of anti-epratuzumab in plasma during administration over 12 weeks
Day 0 (initial administration day) and week 12 (end of the evaluation period)
Study Arms (5)
Placebo Group
PLACEBO COMPARATOREpratuzumab 600 mg Group
EXPERIMENTALEpratuzumab 100 mg Group
EXPERIMENTALEpratuzumab 400 mg Group
EXPERIMENTALEpratuzumab 1200 mg Group
EXPERIMENTALInterventions
Epratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
Epratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
Epratuzumab 100 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
Epratuzumab 600 mg infusions at study weeks 0, 1, 2, and 3.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (7)
09
Fukuoka, Japan
10
Fukuoka, Japan
11
Fukuoka, Japan
03
Kitakyushu, Japan
01
Tokyo, Japan
08
Tokyo, Japan
12
Urayasu, Japan
Related Publications (2)
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
PMID: 33687069DERIVEDTsuru T, Tanaka Y, Kishimoto M, Saito K, Yoshizawa S, Takasaki Y, Miyamura T, Niiro H, Morimoto S, Yamamoto J, Lledo-Garcia R, Shao J, Tatematsu S, Togo O, Koike T. Safety, pharmacokinetics, and pharmacodynamics of epratuzumab in Japanese patients with moderate-to-severe systemic lupus erythematosus: Results from a phase 1/2 randomized study. Mod Rheumatol. 2016;26(1):87-93. doi: 10.3109/14397595.2015.1079292. Epub 2015 Oct 19.
PMID: 26382733DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2011
First Posted
October 7, 2011
Study Start
October 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
February 12, 2014
Record last verified: 2014-01