Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)



Status:Completed
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:9/30/2018
Start Date:December 2010
End Date:June 2015

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A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the
treatment of subjects with Systemic Lupus Erythematosus (SLE).


Inclusion Criteria:

- Positive antinuclear antibodies (ANA) at Screening (Visit 1)

- Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College
of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met

- Active moderate to severe SLE activity as demonstrated by the British Isles Lupus
Assessment Group Index (BILAG)

- Active moderate to severe SLE disease as demonstrated by SLE disease activity index
(SLEDAI) total score

- On stable SLE treatment regimen, including mandatory corticosteroids and
immunosuppressants or antimalarials

Exclusion Criteria:

- Subjects who are breastfeeding, pregnant, or plan to become pregnant

- Subjects with active, severe SLE disease activity which involves the renal system

- Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric
element scoring BILAG level A disease.

- Subjects with the evidence of an immunosuppressive state

- Subjects who, in the opinion of the investigator, are at a particularly high risk of
significant infection

- History of malignant cancer, except the following treated cancers: cervical carcinoma
in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.

- Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit
1).

- Subjects with history of infections, including but not limited to concurrent acute or
chronic viral hepatitis B or C

- Subjects with substance abuse or dependence or other relevant concurrent medical
condition

- Subjects with history of thromboembolic events within 1 year of screening Visit.

- Subjects with significant hematologic abnormalities

- Subject has received treatment with other anti- B cell antibodies within 12 months
prior to screening (visit 1)

- Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs
(NSAIDs) within 12 weeks prior to screening (Visit 1)

- Subject has previously participated in this study or has previously received
epratuzumab treatment.
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