Clinical trial NCT01262365: 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
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: 2010-12-17
Enrollment: 793
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 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: 069
state: Alabama
city: Little Rock
country: United States
facility: 063
state: Arkansas
city: Escondido
country: United States
facility: 085
state: California
city: Los Angeles
country: United States
facility: 031
state: California
city: Los Angeles
country: United States
facility: 051
state: California
city: Los Angeles
country: United States
facility: 089
state: California
city: San Diego
country: United States
facility: 074
state: California
city: San Gabriel
country: United States
facility: 80
state: California
city: Aurora
country: United States
facility: 048
state: Colorado
city: Colorado Springs
country: United States
facility: 037
state: Colorado
city: Farmington
country: United States
facility: 039
state: Connecticut
city: Aventura
country: United States
facility: 042
state: Florida
city: Clearwater
country: United States
facility: 090
state: Florida
city: DeBary
country: United States
facility: 092
state: Florida
city: Jupiter
country: United States
facility: 064
state: Florida
city: Miami
country: United States
facility: 082
state: Florida
city: Ormond Beach
country: United States
facility: 070
state: Florida
city: Palm Harbor
country: United States
facility: 084
state: Florida
city: Tamarac
country: United States
facility: 062
state: Florida
city: Tampa
country: United States
facility: 050
state: Florida
city: Vero Beach
country: United States
facility: 087
state: Florida
city: Lawrenceville
country: United States
facility: 044
state: Georgia
city: Chicago
country: United States
facility: 052
state: Illinois
city: Indianapolis
country: United States
facility: 096
state: Indiana
city: Shreveport
country: United States
facility: 060
state: Louisiana
city: Baltimore
country: United States
facility: 040
state: Maryland
city: Saint Clair Shores
country: United States
facility: 047
state: Michigan
city: Las Cruces
country: United States
facility: 067
state: New Mexico
city: New York
country: United States
facility: 053
state: New York
city: Charlotte
country: United States
facility: 077
state: North Carolina
city: Durham
country: United States
facility: 058
state: North Carolina
city: Columbus
country: United States
facility: 061
state: Ohio
city: Middleburg Heights
country: United States
facility: 071
state: Ohio
city: Oklahoma City
country: United States
facility: 041
state: Oklahoma
city: Oklahoma City
country: United States
facility: 076
state: Oklahoma
city: Oklahoma City
country: United States
facility: 097
state: Oklahoma
city: Duncansville
country: United States
facility: 032
state: Pennsylvania
city: Philadelphia
country: United States
facility: 093
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 073
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 094
state: Pennsylvania
city: Charleston
country: United States
facility: 099
state: South Carolina
city: Columbia
country: United States
facility: 001
state: South Carolina
city: Simpsonville
country: United States
facility: 034
state: South Carolina
city: Memphis
country: United States
facility: 057
state: Tennessee
city: Austin
country: United States
facility: 078
state: Texas
city: Austin
country: United States
facility: 098
state: Texas
city: Dallas
country: United States
facility: 079
state: Texas
city: Houston
country: United States
facility: 055
state: Texas
city: Mesquite
country: United States
facility: 036
state: Texas
city: San Antonio
country: United States
facility: 066
state: Texas
city: Maroochydore
country: Australia
facility: 426
state: Queensland
city: Malvern
country: Australia
facility: 425
state: Victoria
city: Camperdown
country: Australia
facility: 429
city: Clayton
country: Australia
facility: 427
city: Liverpool
country: Australia
facility: 430
city: Brussels
country: Belgium
facility: 106
city: Brussels
country: Belgium
facility: 107
city: Leuven
country: Belgium
facility: 105
city: Liege
country: Belgium
facility: 104
city: Campinas
country: Brazil
facility: 455
city: Porto Alegre
country: Brazil
facility: 453
city: Recife
country: Brazil
facility: 451
city: Rio de Janeiro
country: Brazil
facility: 450
city: Salvador
country: Brazil
facility: 452
city: Sao Paulo
country: Brazil
facility: 454
city: Plovdiv
country: Bulgaria
facility: 201
city: Sofia
country: Bulgaria
facility: 200
city: Sofia
country: Bulgaria
facility: 202
city: Sofia
country: Bulgaria
facility: 203
city: Sofia
country: Bulgaria
facility: 204
city: Sofia
country: Bulgaria
facility: 205
city: Olomouc
country: Czechia
facility: 218
city: Praha 2
country: Czechia
facility: 216
city: Zlin
country: Czechia
facility: 215
city: Tallinn
country: Estonia
facility: 226
city: Lille
country: France
facility: 113
city: Nantes
country: France
facility: 114
city: Paris
country: France
facility: 112
city: Pessac
country: France
facility: 116
city: Berlin
country: Germany
facility: 127
city: Frankfurt
country: Germany
facility: 128
city: Freiburg
country: Germany
facility: 126
city: Hannover
country: Germany
facility: 130
city: Plochingen
country: Germany
facility: 129
city: Bangalore
country: India
facility: 351
city: Hyderabad
country: India
facility: 352
city: Lucknow
country: India
facility: 350
city: Ashkelon
country: Israel
facility: 378
city: Beer Sheva
country: Israel
facility: 376
city: Haifa
country: Israel
facility: 375
city: Haifa
country: Israel
facility: 377
city: Jerusalem
country: Israel
facility: 381
city: Kfar Saba
country: Israel
facility: 382
city: Rehovot
country: Israel
facility: 380
city: Tel Aviv
country: Israel
facility: 379
city: Tel-Hashomer
country: Israel
facility: 383
city: Ferrara
country: Italy
facility: 149
city: Padova
country: Italy
facility: 148
city: Torino
country: Italy
facility: 147
city: Busan
country: Korea, Republic of
facility: 306
city: Daegu
country: Korea, Republic of
facility: 303
city: Daegu
country: Korea, Republic of
facility: 309
city: Daejeon
country: Korea, Republic of
facility: 308
city: Incheon
country: Korea, Republic of
facility: 304
city: Jeonju
country: Korea, Republic of
facility: 310
city: Junggu
country: Korea, Republic of
facility: 301
city: Seoul
country: Korea, Republic of
facility: 307
city: Suwon
country: Korea, Republic of
facility: 302
city: Kaunas
country: Lithuania
facility: 155
city: Klaipeda
country: Lithuania
facility: 156
city: Guadalajara
country: Mexico
facility: 475
city: Guadalajara
country: Mexico
facility: 476
city: Guadalajara
country: Mexico
facility: 478
city: Mérida
country: Mexico
facility: 480
city: Cidra
country: Puerto Rico
facility: 091
city: San Juan
country: Puerto Rico
facility: 086
city: Brasov
country: Romania
facility: 263
city: Bucharest
country: Romania
facility: 260
city: Bucharest
country: Romania
facility: 262
city: Bucharest
country: Romania
facility: 264
city: Cluj-Napoca
country: Romania
facility: 261
city: Ekaterinburg
country: Russian Federation
facility: 281
city: Petrozavodsk
country: Russian Federation
facility: 285
city: Saint Petersburg
country: Russian Federation
facility: 284
city: La Laguna
country: Spain
facility: 165
state: Santa Cruz De Tenerife
city: Bilbao
country: Spain
facility: 164
state: Vizcaya
city: Barcelona
country: Spain
facility: 161
city: Madrid
country: Spain
facility: 162
city: Madrid
country: Spain
facility: 163
city: Malaga
country: Spain
facility: 166
city: Santander
country: Spain
facility: 177
city: Sevilla
country: Spain
facility: 160
city: Changhua
country: Taiwan
facility: 325
city: Chiayi City
country: Taiwan
facility: 326
city: Kaohsiung
country: Taiwan
facility: 328
city: Taichung
country: Taiwan
facility: 329
city: Taipei
country: Taiwan
facility: 330
city: Brighton
country: United Kingdom
facility: 178
city: Doncaster
country: United Kingdom
facility: 182
city: Leeds
country: United Kingdom
facility: 179
city: Romford
country: United Kingdom
facility: 181
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.