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

• 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: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Tracking Information

• First Submitted Date: December 14, 2010
• First Posted Date: December 17, 2010
• Results First Submitted Date: May 30, 2018
• Results First Posted Date: June 29, 2018
• Last Update Posted Date: September 28, 2018
• Study Start Date: December 2010
• Actual Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Systemic Lupus Erythematosus

Intervention

• 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

• 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 *

• Gottenberg JE, Dorner T, Bootsma H, Devauchelle-Pensec V, Bowman SJ, Mariette X, Bartz H, Oortgiesen M, Shock A, Koetse W, Galateanu C, Bongardt S, Wegener WA, Goldenberg DM, Meno-Tetang G, Kosutic G, Gordon C. Efficacy of Epratuzumab, an Anti-CD22 Monoclonal IgG Antibody, in Systemic Lupus Erythematosus Patients With Associated Sjogren's Syndrome: Post Hoc Analyses From the EMBODY Trials. Arthritis Rheumatol. 2018 May;70(5):763-773. doi: 10.1002/art.40425. Epub 2018 Apr 12.
• Clowse ME, Wallace DJ, Furie RA, Petri MA, Pike MC, Leszczynski P, Neuwelt CM, Hobbs K, Keiserman M, Duca L, Kalunian KC, Galateanu C, Bongardt S, Stach C, Beaudot C, Kilgallen B, Gordon C; EMBODY Investigator Group. Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double-Blind, Placebo-Controlled Trials. Arthritis Rheumatol. 2017 Feb;69(2):362-375. doi: 10.1002/art.39856.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 7, 2015): 793
• Original Estimated Enrollment (submitted: December 15, 2010): 780
• Actual Study Completion Date: May 2015
• Actual Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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: NCT01262365
• Other Study ID Numbers: SL0009; 2010-018563-41 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: UCB Pharma
• Original Responsible Party: Study Director, UCB, Inc.
• Current Study Sponsor: UCB Pharma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: UCb Clinical Trial Call Center; +1 877 822 9493 (UCB)

• PRS Account: UCB Pharma
• Verification Date: June 2018