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

Completed · Phase 3 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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

Key facts

Study ID

NCT01262365

Run by

UCB Pharma

People needed

793

Starts

2010-12-01

Expected to finish

2015-05-01

Last updated by the study team

2018-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 SLEDAI total score.
• On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials

You may not qualify if…

• 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.

Where it is running

• 063 — Little Rock, Arkansas, United States
• 085 — Escondido, California, United States
• 031 — Los Angeles, California, United States
• 051 — Los Angeles, California, United States
• 089 — Los Angeles, California, United States
• 074 — San Diego, California, United States
• 80 — San Gabriel, California, United States
• 048 — Aurora, Colorado, United States
• 037 — Colorado Springs, Colorado, United States
• 039 — Farmington, Connecticut, United States
• 042 — Aventura, Florida, United States
• 090 — Clearwater, Florida, United States
• 092 — DeBary, Florida, United States
• 064 — Jupiter, Florida, United States
• 082 — Miami, Florida, United States
• 070 — Ormond Beach, Florida, United States
• 084 — Palm Harbor, Florida, United States
• 062 — Tamarac, Florida, United States
• 050 — Tampa, Florida, United States
• 087 — Vero Beach, Florida, United States
• 044 — Lawrenceville, Georgia, United States
• 052 — Chicago, Illinois, United States
• 096 — Indianapolis, Indiana, United States
• 060 — Shreveport, Louisiana, United States
• 069 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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