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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01449071
First received: October 3, 2011
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Area under the concentration time curve (AUC) [ Time Frame: From baseline to 12 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0 (initial administration day) and week 12 (end of the evaluation period) ] [ Designated as safety issue: No ]
    Blood drawing for anti- epratuzumab is carried out at initial administration day (day 0) and end of the evaluation period (week 12).


Enrollment: 20
Study Start Date: October 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449071

Locations
Japan
09
Fukuoka, Japan
10
Fukuoka, Japan
11
Fukuoka, Japan
03
Kitakyushu, Japan
08
Tokyo, Japan
01
Tokyo, Japan
12
Urayasu, Japan
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01449071     History of Changes
Other Study ID Numbers: SL0026
Study First Received: October 3, 2011
Last Updated: January 16, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by UCB, Inc.:
Lupus
Monoclonal antibody
B-cell immunotherapy
Epratuzumab

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014