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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 14, 2010
First Posted Date  ICMJE December 17, 2010
Results First Submitted Date  ICMJE May 30, 2018
Results First Posted Date  ICMJE June 29, 2018
Last Update Posted Date September 28, 2018
Study Start Date  ICMJE December 2010
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2010)
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index [ Time Frame: Week 48 ]
The percent of subjects meeting treatment response criteria at Week 48 according to a combined response index
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2010)
  • The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index [ Time Frame: Week 24 ]
    The percent of subjects meeting treatment response criteria at Week 24 according to a combined response index
  • The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index [ Time Frame: Week 12 ]
    The percent of subjects meeting treatment response criteria at Week 12 according to a combined response index
  • The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index [ Time Frame: Week 36 ]
    The percent of subjects meeting treatment response criteria at Week 36 according to a combined response index
  • Change From Baseline in Daily Corticosteroid Dose at Week 24 [ Time Frame: Baseline, Week 24 ]
    Change from Baseline in daily corticosteroid dose at week 24
  • Change From Baseline in Daily Corticosteroid Dose at Week 48 [ Time Frame: Baseline, Week 48 ]
    Change from Baseline in daily corticosteroid dose at week 48
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: Epratuzumab
    600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo (Weekly infusion)
    Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
    Intervention: Drug: Placebo
  • 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
    Intervention: Drug: Epratuzumab
  • 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
    Interventions:
    • Drug: Epratuzumab
    • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2015)
793
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2010)
780
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Bulgaria,   Czechia,   Estonia,   France,   Germany,   India,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Mexico,   Puerto Rico,   Romania,   Russian Federation,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01262365
Other Study ID Numbers  ICMJE SL0009
2010-018563-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCb Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP