Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
EMBODY2
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
2 other identifiers
interventional
791
16 countries
133
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2010
Longer than P75 for phase_3
133 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 14, 2010
CompletedFirst Posted
Study publicly available on registry
December 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
June 29, 2018
CompletedDecember 4, 2020
November 1, 2020
4.4 years
December 14, 2010
May 30, 2018
November 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
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.
At Week 48
Secondary Outcomes (5)
The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index
At Week 24
The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index
At Week 12
The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index
At Week 36
Change From Baseline in Daily Corticosteroid Dose at Week 24
At Week 24
Change From Baseline in Daily Corticosteroid Dose at Week 48
At Week 48
Study Arms (3)
Placebo (Weekly infusion)
PLACEBO COMPARATORPlacebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
Epratuzumab 600 mg per week
EXPERIMENTAL600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
Epratuzumab 1200 mg every other week
EXPERIMENTAL1200 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
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (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
532
Denver, Colorado, United States
511
Bridgeport, Connecticut, United States
514
Brandon, Florida, United States
533
Fort Lauderdale, Florida, United States
518
Plantation, Florida, United States
585
Port Orange, Florida, United States
538
Tampa, Florida, United States
537
Atlanta, Georgia, United States
587
Decatur, Georgia, United States
590
Idaho Falls, Idaho, United States
543
Bowling Green, Kentucky, United States
592
Lexington, Kentucky, United States
576
New Orleans, Louisiana, United States
572
Boston, Massachusetts, United States
554
Ann Arbor, Michigan, United States
513
Lansing, Michigan, United States
599
Lansing, Michigan, United States
575
Florissant, Missouri, United States
549
St Louis, Missouri, United States
596
Nashua, New Hampshire, United States
593
Clifton, New Jersey, United States
568
Freehold, New Jersey, United States
551
Brooklyn, New York, United States
553
Lake Success, New York, United States
545
Manhasset, New York, United States
577
Roslyn, New York, United States
559
Charlotte, North Carolina, United States
547
Tulsa, Oklahoma, United States
561
Wyomissing, Pennsylvania, United States
535
Charleston, South Carolina, United States
598
Myrtle Beach, South Carolina, United States
571
Jackson, Tennessee, United States
574
Amarillo, Texas, United States
570
Austin, Texas, United States
541
Houston, Texas, United States
563
Houston, Texas, United States
562
San Antonio, Texas, United States
552
Chesapeake, Virginia, United States
534
Seattle, Washington, United States
954
Belo Horizonte, Brazil
956
Campinas, Brazil
955
Goiânia, Brazil
950
Juiz de Fora, Brazil
952
Rio de Janeiro, Brazil
506
St. John's, Newfoundland and Labrador, Canada
507
Mississauga, Ontario, Canada
508
Rimouski, Quebec, Canada
502
Hamilton, Canada
500
London, Canada
504
Toronto, Canada
517
Victoria, Canada
613
Caen, France
618
Limoges, France
617
Montpellier, France
614
Paris, France
616
Toulouse, France
628
Berlin, Germany
633
Berlin, Germany
625
Cologne, Germany
636
Dessau, Germany
637
Hamburg, Germany
632
Herne, Germany
629
Kiel, Germany
626
Leipzig, Germany
634
Mainz, Germany
627
Münster, Germany
639
Wiesbaden, Germany
631
Zerbst, Germany
712
Budapest, Hungary
716
Budapest, Hungary
718
Budapest, Hungary
717
Debrecen, Hungary
711
Szeged, Hungary
715
Szeged, Hungary
713
Zalaegerszeg, Hungary
852
Ahmedabad, India
853
Bangalore, India
648
Milan, Italy
647
Pisa, Italy
646
Roma, Italy
978
Cuauhtémoc, Mexico
976
Mexico City, Mexico
982
México, Mexico
981
Torreón, Mexico
743
Bydgoszcz, Poland
744
Częstochowa, Poland
752
Elblag, Poland
745
Katowice, Poland
746
Katowice, Poland
748
Lublin, Poland
750
Lublin, Poland
742
Poznan, Poland
747
Szczecin, Poland
751
Ustroń, Poland
749
Warsaw, Poland
757
Bucharest, Romania
758
Bucharest, Romania
760
Bucharest, Romania
759
Constanța, Romania
756
Galati, Romania
761
Iași, Romania
778
Kemerovo, Russia
780
Kemerovo, Russia
779
Moscow, Russia
901
Cape Town, South Africa
902
Durban, South Africa
903
Stellenbosch, South Africa
661
Barcelona, Spain
660
Getafe, Spain
662
Las Palmas de Gran Canaria, Spain
664
Madrid, Spain
663
Santiago de Compostela, Spain
659
Vigo, Spain
791
Donetsk, Ukraine
790
Kiev, Ukraine
794
Kiev, Ukraine
797
Kiev, Ukraine
792
Luhansk, Ukraine
793
Odesa, Ukraine
796
Vinnytsia, Ukraine
677
Birmingham, United Kingdom
678
Christchurch, United Kingdom
679
London, United Kingdom
Related Publications (2)
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.
PMID: 29381843DERIVEDClowse 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.
PMID: 27598855DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Care
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2010
First Posted
December 16, 2010
Study Start
December 1, 2010
Primary Completion
May 1, 2015
Study Completion
June 1, 2015
Last Updated
December 4, 2020
Results First Posted
June 29, 2018
Record last verified: 2020-11