Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)

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 (EMBODY 1) - EMBODY 1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018563-41-BE

Enrollment

780

Registered

2010-11-19

Start date

2011-05-25

Completion date

Unknown

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythmatosus MedDRA version: 17.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Epratuzumab Product Code: CDP3194 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Epratuzumab CAS Number: 205923-57-5 Current Sponsor code: CDP3194 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

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 SLEDAI total score. - On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 740 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

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 randomization (visit 2) - Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1) - Subject has previously received epratuzumab treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with moderate to severe general SLE despite standard of care treatments (ie, corticosteroids, and potentially antimalarials and immunosuppressants) continued from Baseline.;Secondary Objective: The secondary objectives of the study are to assess the safety, tolerability, and immunogenicity of epratuzumab, and to assess the steroid-sparing effects of epratuzumab treatment.;Primary end point(s): The percent of subjects meeting treatment response criteria at Week 48 according to a combined response index. ;Timepoint(s) of evaluation of this end point: 48 weeks	—

Measure

Time frame

Main Objective: The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with moderate to severe general SLE despite standard of care treatments (ie, corticosteroids, and potentially antimalarials and immunosuppressants) continued from Baseline.;Secondary Objective: The secondary objectives of the study are to assess the safety, tolerability, and immunogenicity of epratuzumab, and to assess the steroid-sparing effects of epratuzumab treatment.;Primary end point(s): The percent of subjects meeting treatment response criteria at Week 48 according to a combined response index. ;Timepoint(s) of evaluation of this end point: 48 weeks

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Secondary

Measure	Time frame
Secondary end point(s): a) The percent of subjects meeting treatment response criteria at Week 24, according to the combined index. b) The percent of subjects meeting treatment response criteria at Week 12, according to the combined index. c) The percent of subjects meeting treatment response criteria at Week 36, according to the combined index. d) Change from Baseline in daily corticosteroid dose at Week 24 e) Change from Baseline in daily corticosteroid dose at Week 48;Timepoint(s) of evaluation of this end point: a) 24 weeks b) 12 weeks c) 36 weeks d) Baseline - 24 weeks e) Baseline - 48 weeks	—

Measure

Time frame

Secondary end point(s): a) The percent of subjects meeting treatment response criteria at Week 24, according to the combined index. b) The percent of subjects meeting treatment response criteria at Week 12, according to the combined index. c) The percent of subjects meeting treatment response criteria at Week 36, according to the combined index. d) Change from Baseline in daily corticosteroid dose at Week 24 e) Change from Baseline in daily corticosteroid dose at Week 48;Timepoint(s) of evaluation of this end point: a) 24 weeks b) 12 weeks c) 36 weeks d) Baseline - 24 weeks e) Baseline - 48 weeks

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Countries

Australia, Belgium, Brazil, Bulgaria, Czech Republic, Estonia, Germany, India, Israel, Italy, Korea, Republic of, Lithuania, Mexico, Russian Federation, Spain, Taiwan, United Kingdom

Contacts

Public ContactClin Trial Reg & Results Disclosure

UCB BIOSCIENCES GmbH

clinicaltrials@ucb.com+49217348 1515

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026