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

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449071
• Other study ID #: SL0026
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 3, 2011
• Last updated: January 16, 2014
• Start date: October 2011
• Est. completion date: March 2013

Study information

• Verified date: January 2014
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• Placebo
Placebo infusions at study weeks 0, 1, 2, and 3.
• Epratuzumab 400 mg
Epratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
• Epratuzumab 1200 mg
Epratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
• Epratuzumab 100 mg
Epratuzumab 100 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
• Epratuzumab 600 mg
Epratuzumab 600 mg infusions at study weeks 0, 1, 2, and 3.

Locations

Country	Name	City	State
Japan	09	Fukuoka
Japan	10	Fukuoka
Japan	11	Fukuoka
Japan	03	Kitakyushu
Japan	01	Tokyo
Japan	08	Tokyo
Japan	12	Urayasu

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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).	Day 0 (initial administration day) and week 12 (end of the evaluation period)	No