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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo infusions at study weeks 0, 1, 2, and 3.

Epratuzumab 600 mg Group

Group Type EXPERIMENTAL

Epratuzumab 600 mg

Intervention Type BIOLOGICAL

Epratuzumab 600 mg infusions at study weeks 0, 1, 2, and 3.

Epratuzumab 100 mg Group

Group Type EXPERIMENTAL

Epratuzumab 100 mg

Intervention Type BIOLOGICAL

Epratuzumab 100 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.

Epratuzumab 400 mg Group

Group Type EXPERIMENTAL

Epratuzumab 400 mg

Intervention Type BIOLOGICAL

Epratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.

Epratuzumab 1200 mg Group

Group Type EXPERIMENTAL

Epratuzumab 1200 mg

Intervention Type BIOLOGICAL

Epratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.

Interventions

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Placebo

Placebo infusions at study weeks 0, 1, 2, and 3.

Intervention Type BIOLOGICAL

Epratuzumab 400 mg

Epratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.

Intervention Type BIOLOGICAL

Epratuzumab 1200 mg

Epratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.

Intervention Type BIOLOGICAL

Epratuzumab 100 mg

Epratuzumab 100 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.

Intervention Type BIOLOGICAL

Epratuzumab 600 mg

Epratuzumab 600 mg infusions at study weeks 0, 1, 2, and 3.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No