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

Phase 3

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Placebo; Drug: Epratuzumab

• Registration Number: NCT01261793
• Lead Sponsor: UCB Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-16
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Disposition First Submitted: 2016-01-12
• Disposition First Submitted QC: 2016-01-12
• Disposition First Posted: 2016-02-05
• Results First Submitted: 2018-05-30
• Results First Submitted QC: 2018-06-04
• Results First Posted: 2018-06-29
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 791

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epratuzumab 1200 mg every other week	Placebo	1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
Placebo (Weekly infusion)	Placebo	Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
Epratuzumab 1200 mg every other week	Epratuzumab	1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
Epratuzumab 600 mg per week	Epratuzumab	600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles

Primary Outcome Measures

Name	Time	Method
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index	At Week 48	Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.

Secondary Outcome Measures

Name	Time	Method
The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index	At Week 12	Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index	At Week 36	Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index	At Week 24	Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
Change From Baseline in Daily Corticosteroid Dose at Week 24	At Week 24	Participants were grouped into 4 categories: Dose decreased by \>50%, Dose decreased \>0% to ≤50%, No change in dose and Dose increased or missing data.
Change From Baseline in Daily Corticosteroid Dose at Week 48	At Week 48	Participants were grouped into 4 categories: Dose decreased by \>50%, Dose decreased \>0% to ≤50%, No change in dose and Dose increased or missing data.

Trial Locations

Locations (133)

539; 🇺🇸 Birmingham, Alabama, United States

557; 🇺🇸 Little Rock, Arkansas, United States

515; 🇺🇸 Hemet, California, United States

544; 🇺🇸 Huntington Beach, California, United States

550; 🇺🇸 La Jolla, California, United States

548; 🇺🇸 Los Angeles, California, United States

589; 🇺🇸 San Diego, California, United States

531; 🇺🇸 San Leandro, California, United States

558; 🇺🇸 Torrance, California, United States

594; 🇺🇸 Westlake Village, California, United States

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