Clinical trial NCT01261793: Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Monoclonal antibody
B-Cell immunotherapy
Epratuzumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-12-16
Enrollment: 791
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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 SLE disease activity index (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.

Primary outcomes:
measure: The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
timeFrame: At Week 48
Secondary outcomes:
measure: The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index
timeFrame: At Week 24
measure: The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index
timeFrame: At Week 12
measure: The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index
timeFrame: At Week 36
measure: Change From Baseline in Daily Corticosteroid Dose at Week 24
timeFrame: At Week 24
measure: Change From Baseline in Daily Corticosteroid Dose at Week 48
timeFrame: At Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 539
state: Alabama
city: Little Rock
country: United States
facility: 557
state: Arkansas
city: Hemet
country: United States
facility: 515
state: California
city: Huntington Beach
country: United States
facility: 544
state: California
city: La Jolla
country: United States
facility: 550
state: California
city: Los Angeles
country: United States
facility: 548
state: California
city: San Diego
country: United States
facility: 589
state: California
city: San Leandro
country: United States
facility: 531
state: California
city: Torrance
country: United States
facility: 558
state: California
city: Westlake Village
country: United States
facility: 594
state: California
city: Denver
country: United States
facility: 532
state: Colorado
city: Bridgeport
country: United States
facility: 511
state: Connecticut
city: Brandon
country: United States
facility: 514
state: Florida
city: Fort Lauderdale
country: United States
facility: 533
state: Florida
city: Plantation
country: United States
facility: 518
state: Florida
city: Port Orange
country: United States
facility: 585
state: Florida
city: Tampa
country: United States
facility: 538
state: Florida
city: Atlanta
country: United States
facility: 537
state: Georgia
city: Decatur
country: United States
facility: 587
state: Georgia
city: Idaho Falls
country: United States
facility: 590
state: Idaho
city: Bowling Green
country: United States
facility: 543
state: Kentucky
city: Lexington
country: United States
facility: 592
state: Kentucky
city: New Orleans
country: United States
facility: 576
state: Louisiana
city: Boston
country: United States
facility: 572
state: Massachusetts
city: Ann Arbor
country: United States
facility: 554
state: Michigan
city: Lansing
country: United States
facility: 513
state: Michigan
city: Lansing
country: United States
facility: 599
state: Michigan
city: Florissant
country: United States
facility: 575
state: Missouri
city: Saint Louis
country: United States
facility: 549
state: Missouri
city: Nashua
country: United States
facility: 596
state: New Hampshire
city: Clifton
country: United States
facility: 593
state: New Jersey
city: Freehold
country: United States
facility: 568
state: New Jersey
city: Brooklyn
country: United States
facility: 551
state: New York
city: Lake Success
country: United States
facility: 553
state: New York
city: Manhasset
country: United States
facility: 545
state: New York
city: Roslyn
country: United States
facility: 577
state: New York
city: Charlotte
country: United States
facility: 559
state: North Carolina
city: Tulsa
country: United States
facility: 547
state: Oklahoma
city: Wyomissing
country: United States
facility: 561
state: Pennsylvania
city: Charleston
country: United States
facility: 535
state: South Carolina
city: Myrtle Beach
country: United States
facility: 598
state: South Carolina
city: Jackson
country: United States
facility: 571
state: Tennessee
city: Amarillo
country: United States
facility: 574
state: Texas
city: Austin
country: United States
facility: 570
state: Texas
city: Houston
country: United States
facility: 541
state: Texas
city: Houston
country: United States
facility: 563
state: Texas
city: San Antonio
country: United States
facility: 562
state: Texas
city: Chesapeake
country: United States
facility: 552
state: Virginia
city: Seattle
country: United States
facility: 534
state: Washington
city: Belo Horizonte
country: Brazil
facility: 954
city: Campinas
country: Brazil
facility: 956
city: Goiânia
country: Brazil
facility: 955
city: Juiz de Fora
country: Brazil
facility: 950
city: Rio de Janeiro
country: Brazil
facility: 952
city: St. John's
country: Canada
facility: 506
state: Newfoundland and Labrador
city: Mississauga
country: Canada
facility: 507
state: Ontario
city: Rimouski
country: Canada
facility: 508
state: Quebec
city: Hamilton
country: Canada
facility: 502
city: London
country: Canada
facility: 500
city: Toronto
country: Canada
facility: 504
city: Victoria
country: Canada
facility: 517
city: Caen
country: France
facility: 613
city: Limoges Cedex
country: France
facility: 618
city: Montpellier Cedex 5
country: France
facility: 617
city: Paris
country: France
facility: 614
city: Toulouse Cedex 9
country: France
facility: 616
city: Berlin
country: Germany
facility: 628
city: Berlin
country: Germany
facility: 633
city: Dessau
country: Germany
facility: 636
city: Hamburg
country: Germany
facility: 637
city: Herne
country: Germany
facility: 632
city: Kiel
country: Germany
facility: 629
city: Köln
country: Germany
facility: 625
city: Leipzig
country: Germany
facility: 626
city: Mainz
country: Germany
facility: 634
city: Münster
country: Germany
facility: 627
city: Wiesbaden
country: Germany
facility: 639
city: Zerbst
country: Germany
facility: 631
city: Budapest
country: Hungary
facility: 712
city: Budapest
country: Hungary
facility: 716
city: Budapest
country: Hungary
facility: 718
city: Debrecen
country: Hungary
facility: 717
city: Szeged
country: Hungary
facility: 711
city: Szeged
country: Hungary
facility: 715
city: Zalaegerszeg
country: Hungary
facility: 713
city: Ahmedabad
country: India
facility: 852
city: Bangalore
country: India
facility: 853
city: Milano
country: Italy
facility: 648
city: Pisa
country: Italy
facility: 647
city: Roma
country: Italy
facility: 646
city: Cuauhtémoc
country: Mexico
facility: 978
city: Mexico City
country: Mexico
facility: 976
city: Mexico
country: Mexico
facility: 982
city: Torreon
country: Mexico
facility: 981
city: Bydgoszcz
country: Poland
facility: 743
city: Czestochowa
country: Poland
facility: 744
city: Elblag
country: Poland
facility: 752
city: Katowice
country: Poland
facility: 745
city: Katowice
country: Poland
facility: 746
city: Lublin
country: Poland
facility: 748
city: Lublin
country: Poland
facility: 750
city: Poznan
country: Poland
facility: 742
city: Szczecin
country: Poland
facility: 747
city: Ustron
country: Poland
facility: 751
city: Warsaw
country: Poland
facility: 749
city: Bucharest
country: Romania
facility: 757
city: Bucharest
country: Romania
facility: 758
city: Bucharest
country: Romania
facility: 760
city: Constanta
country: Romania
facility: 759
city: Galati
country: Romania
facility: 756
city: Iasi
country: Romania
facility: 761
city: Kemerovo
country: Russian Federation
facility: 778
city: Kemerovo
country: Russian Federation
facility: 780
city: Moscow
country: Russian Federation
facility: 779
city: Cape Town
country: South Africa
facility: 901
city: Durban
country: South Africa
facility: 902
city: Stellenbosch
country: South Africa
facility: 903
city: Barcelona
country: Spain
facility: 661
city: Getafe
country: Spain
facility: 660
city: Las Palmas de Gran Canaria
country: Spain
facility: 662
city: Madrid
country: Spain
facility: 664
city: Santiago de Compostela
country: Spain
facility: 663
city: Vigo
country: Spain
facility: 659
city: Donetsk
country: Ukraine
facility: 791
city: Kiev
country: Ukraine
facility: 790
city: Kiev
country: Ukraine
facility: 794
city: Kiev
country: Ukraine
facility: 797
city: Luhansk
country: Ukraine
facility: 792
city: Odessa
country: Ukraine
facility: 793
city: Vinnytsya
country: Ukraine
facility: 796
city: Birmingham
country: United Kingdom
facility: 677
city: Christchurch
country: United Kingdom
facility: 678
city: London
country: United Kingdom
facility: 679
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.