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Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (EMBODY1)

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ClinicalTrials.gov Identifier: NCT01262365
Recruitment Status : Completed
First Posted : December 17, 2010
Results First Posted : June 29, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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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)

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Epratuzumab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 793 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2010
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo (Weekly infusion)
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
 Drug: Placebo
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
Experimental: Epratuzumab 600 mg per week
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
 Drug: Epratuzumab
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles
Experimental: Epratuzumab 1200 mg every other week
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
 Drug: Epratuzumab
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles

Drug: Placebo
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles


Outcome Measures
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Primary Outcome Measures :
  1. The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index [ Time Frame: At Week 48 ]
    Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. 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 :
  1. The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index [ Time Frame: At Week 24 ]
    Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. 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.

  2. The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index [ Time Frame: At Week 12 ]
    Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. 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.

  3. The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index [ Time Frame: At Week 36 ]
    Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. 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.

  4. Change From Baseline in Daily Corticosteroid Dose at Week 24 [ Time Frame: At Week 24 ]
    Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.

  5. Change From Baseline in Daily Corticosteroid Dose at Week 48 [ Time Frame: At Week 48 ]
    Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262365


Locations
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Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCb Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01262365    
Other Study ID Numbers: SL0009
2010-018563-41 ( EudraCT Number )
First Posted: December 17, 2010    Key Record Dates
Results First Posted: June 29, 2018
Last Update Posted: September 28, 2018
Last Verified: June 2018
Keywords provided by UCB Pharma:
Lupus
Monoclonal antibody
B-Cell immunotherapy
Epratuzumab
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Epratuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents