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

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Placebo
Epratuzumab 400 mg
Epratuzumab 1200 mg
Epratuzumab 100 mg
Epratuzumab 600 mg
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Lupus, Monoclonal antibody, B-cell immunotherapy, Epratuzumab

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • 09
  • 10
  • 11
  • 03
  • 01
  • 08
  • 12

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo Group

Epratuzumab 600 mg Group

Epratuzumab 100 mg Group

Epratuzumab 400 mg Group

Epratuzumab 1200 mg Group

Arm Description

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

Incidence of anti-epratuzumab in plasma during administration over 12 weeks
Blood drawing for anti- epratuzumab is carried out at initial administration day (day 0) and end of the evaluation period (week 12).

Full Information

First Posted
October 3, 2011
Last Updated
January 16, 2014
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01449071
Brief Title
Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)
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 Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Lupus, Monoclonal antibody, B-cell immunotherapy, Epratuzumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Title
Epratuzumab 600 mg Group
Arm Type
Experimental
Arm Title
Epratuzumab 100 mg Group
Arm Type
Experimental
Arm Title
Epratuzumab 400 mg Group
Arm Type
Experimental
Arm Title
Epratuzumab 1200 mg Group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo infusions at study weeks 0, 1, 2, and 3.
Intervention Type
Biological
Intervention Name(s)
Epratuzumab 400 mg
Intervention Description
Epratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
Intervention Type
Biological
Intervention Name(s)
Epratuzumab 1200 mg
Intervention Description
Epratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
Intervention Type
Biological
Intervention Name(s)
Epratuzumab 100 mg
Intervention Description
Epratuzumab 100 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
Intervention Type
Biological
Intervention Name(s)
Epratuzumab 600 mg
Intervention Description
Epratuzumab 600 mg infusions at study weeks 0, 1, 2, and 3.
Primary Outcome Measure Information:
Title
Area under the concentration time curve (AUC)
Description
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
Time Frame
From baseline to 12 weeks
Title
Half-life (t1/2)
Description
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.
Time Frame
From baseline to 12 weeks
Title
Maximum plasma Concentration (Cmax)
Description
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.
Time Frame
From Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Incidence of anti-epratuzumab in plasma during administration over 12 weeks
Description
Blood drawing for anti- epratuzumab is carried out at initial administration day (day 0) and end of the evaluation period (week 12).
Time Frame
Day 0 (initial administration day) and week 12 (end of the evaluation period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
09
City
Fukuoka
Country
Japan
Facility Name
10
City
Fukuoka
Country
Japan
Facility Name
11
City
Fukuoka
Country
Japan
Facility Name
03
City
Kitakyushu
Country
Japan
Facility Name
01
City
Tokyo
Country
Japan
Facility Name
08
City
Tokyo
Country
Japan
Facility Name
12
City
Urayasu
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33687069
Citation
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.
Results Reference
derived
PubMed Identifier
26382733
Citation
Tsuru 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.
Results Reference
derived

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

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