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

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ClinicalTrials.gov Identifier: NCT01449071
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : February 12, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : October 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Area under the concentration time curve (AUC) [ Time Frame: 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


  2. Half-life (t1/2) [ Time Frame: 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.


  3. Maximum plasma Concentration (Cmax) [ Time Frame: 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 :
  1. 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) ]
    Blood drawing for anti- epratuzumab is carried out at initial administration day (day 0) and end of the evaluation period (week 12).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449071


Locations
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Japan
09
Fukuoka, Japan
10
Fukuoka, Japan
11
Fukuoka, Japan
03
Kitakyushu, Japan
01
Tokyo, Japan
08
Tokyo, Japan
12
Urayasu, Japan
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01449071    
Other Study ID Numbers: SL0026
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: January 2014
Keywords provided by UCB Pharma:
Lupus
Monoclonal antibody
B-cell immunotherapy
Epratuzumab
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Epratuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents