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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000298819
Ethics application status
Approved
Date submitted
7/03/2012
Date registered
15/03/2012
Date last updated
15/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study to Evaluate the Safety and Tolerability of Epratuzumab in Patients With Systemic Lupus Erythematosus.
Scientific title
A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4)
Secondary ID [1] 273550 0
NCT01408576 Clintrials.gov
Universal Trial Number (UTN)
Trial acronym
EMBODY 4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 265772 0
Condition category
Condition code
Inflammatory and Immune System 265920 265920 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Epratuzumab 600mg intravenous infusions delivered once a week (QW) via slow infusion for a total of 4 consecutive weeks (cumulative dose (CMD) 2400mg) over eight 12-week treatment cycles
Intervention code [1] 264508 0
Treatment: Drugs
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266681 0
The percentage of subjects meeting treatment response criteria at week 48 and week 96 according to a combined response index which incorporates criteria for achievement from the BILAG, SLEDAI, and physician's global assessment of disease activity.
Timepoint [1] 266681 0
week 48 and week 96
Secondary outcome [1] 296552 0
The percentage of subjects meeting treatment response criteria at all other time points assessed during the study according to a combined response index which incorporates criteria for achievement from the BILAG, SLEDAI, and physician's global assessment of disease activity.
Timepoint [1] 296552 0
All other time points assessed during the study

Eligibility
Key inclusion criteria
The subject has completed double-blind study SL0009 (ACTRN12611000464965) or SL0010, or the subject has terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy, as described in the respective protocols and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment in SL0012.

The subject has maintained the eligibility requirements (including concomitant medication restrictions) throughout their participation in the prior study

Woman of childbearing potential using an acceptable method of birth control
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subject has active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease

Subject has active, severe, SLE disease activity which involves the renal system defined by BILAG renal level A activity

Evidence of an immunosuppressive state

Subjects with a history of chronic infections, including but not limited to subjects with concurrent acute or chronic viral hepatitis B or C

Subjects with substance abuse/dependence or other concurrent medical conditions

Subjects with significant hematologic abnormalities

History of malignant cancer

Subject has used the prohibited medications

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects who complete the Phase 3, double-blind, placebo-controlled study, SL0009, or terminate prematurely (at Week 16 or later) due to lack of efficacy, are eligible to enroll in this open-label extension study.

To enroll a subject (Visit 1), the investigator will call the IVRS and provide brief details about the subject to be enrolled. Each subject will keep the subject number assigned at Screening in SL0009, which serves as the subject identifier throughout SL0012. All subjects will receive epratuzumab 600mg infusions delivered QW for a total of 4 consecutive weeks (CMD 2400mg) repeated every 12 weeks.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This study is open label and all subjects receive the same treatment. The interactive voice response system (IVRS) is responsible for issuing subject kits of epratuzumab, as appropriate, according to the visit schedule.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3966 0
3145
Recruitment postcode(s) [2] 3967 0
3168
Recruitment postcode(s) [3] 3968 0
4558
Recruitment postcode(s) [4] 3969 0
2050
Recruitment outside Australia
Country [1] 3499 0
Belgium
State/province [1] 3499 0
Country [2] 3500 0
Brazil
State/province [2] 3500 0
Country [3] 3501 0
Bulgaria
State/province [3] 3501 0
Country [4] 3502 0
Canada
State/province [4] 3502 0
British Columbia
Country [5] 3503 0
Canada
State/province [5] 3503 0
Ontario
Country [6] 3504 0
Canada
State/province [6] 3504 0
Quebec
Country [7] 3505 0
Czech Republic
State/province [7] 3505 0
Country [8] 3506 0
France
State/province [8] 3506 0
Country [9] 3507 0
Germany
State/province [9] 3507 0
Baden-Wurttemberg
Country [10] 3508 0
Hungary
State/province [10] 3508 0
Country [11] 3509 0
India
State/province [11] 3509 0
Karnataka
Country [12] 3510 0
Israel
State/province [12] 3510 0
Country [13] 3511 0
Italy
State/province [13] 3511 0
Country [14] 3512 0
Korea, Democratic People's Republic Of
State/province [14] 3512 0
Country [15] 3513 0
Mexico
State/province [15] 3513 0
Country [16] 3514 0
Netherlands
State/province [16] 3514 0
Country [17] 3515 0
Poland
State/province [17] 3515 0
Country [18] 3516 0
Romania
State/province [18] 3516 0
Country [19] 3517 0
Russian Federation
State/province [19] 3517 0
Country [20] 3518 0
South Africa
State/province [20] 3518 0
Western Cape Province
Country [21] 3519 0
Spain
State/province [21] 3519 0
Country [22] 3520 0
Taiwan, Province Of China
State/province [22] 3520 0
Country [23] 3521 0
Ukraine
State/province [23] 3521 0
Country [24] 3522 0
United Kingdom
State/province [24] 3522 0
Essex
Country [25] 3523 0
United Kingdom
State/province [25] 3523 0
South Yorkshire
Country [26] 3524 0
United Kingdom
State/province [26] 3524 0
West Yorkshire
Country [27] 3525 0
United Kingdom
State/province [27] 3525 0
East Sussex
Country [28] 3526 0
United Kingdom
State/province [28] 3526 0
London
Country [29] 3527 0
United Kingdom
State/province [29] 3527 0
West Midlands
Country [30] 3528 0
United Kingdom
State/province [30] 3528 0
Dorset
Country [31] 3529 0
United States of America
State/province [31] 3529 0
Alabama
Country [32] 3530 0
United States of America
State/province [32] 3530 0
Arkansas
Country [33] 3531 0
United States of America
State/province [33] 3531 0
California
Country [34] 3532 0
United States of America
State/province [34] 3532 0
Colorado
Country [35] 3533 0
United States of America
State/province [35] 3533 0
Connecticut
Country [36] 3534 0
United States of America
State/province [36] 3534 0
Florida
Country [37] 3535 0
United States of America
State/province [37] 3535 0
Georgia
Country [38] 3536 0
United States of America
State/province [38] 3536 0
Illinois
Country [39] 3537 0
United States of America
State/province [39] 3537 0
Kentucky
Country [40] 3538 0
United States of America
State/province [40] 3538 0
Louisiana
Country [41] 3539 0
United States of America
State/province [41] 3539 0
Maryland
Country [42] 3540 0
United States of America
State/province [42] 3540 0
Michigan
Country [43] 3541 0
United States of America
State/province [43] 3541 0
Minnesota
Country [44] 3542 0
United States of America
State/province [44] 3542 0
Missouri
Country [45] 3543 0
United States of America
State/province [45] 3543 0
New York
Country [46] 3544 0
United States of America
State/province [46] 3544 0
North Carolina
Country [47] 3545 0
United States of America
State/province [47] 3545 0
North Dakota
Country [48] 3546 0
United States of America
State/province [48] 3546 0
Ohio
Country [49] 3547 0
United States of America
State/province [49] 3547 0
Oklahoma
Country [50] 3548 0
United States of America
State/province [50] 3548 0
Oregon
Country [51] 3549 0
United States of America
State/province [51] 3549 0
Pennsylvania
Country [52] 3550 0
United States of America
State/province [52] 3550 0
South Carolina
Country [53] 3551 0
United States of America
State/province [53] 3551 0
Tennessee
Country [54] 3552 0
United States of America
State/province [54] 3552 0
Texas
Country [55] 3553 0
United States of America
State/province [55] 3553 0
Virginia
Country [56] 3554 0
United States of America
State/province [56] 3554 0
Washington
Country [57] 3555 0
United States of America
State/province [57] 3555 0
West Virginia
Country [58] 3556 0
India
State/province [58] 3556 0
Uttar Pradesh
Country [59] 3557 0
India
State/province [59] 3557 0
Lucknow
Country [60] 3558 0
India
State/province [60] 3558 0
Andhra Pradesh
Country [61] 3559 0
Germany
State/province [61] 3559 0
Nordrhein-Westfalen
Country [62] 3560 0
Germany
State/province [62] 3560 0
Sachsen
Country [63] 3561 0
Germany
State/province [63] 3561 0
Berlin
Country [64] 3562 0
Germany
State/province [64] 3562 0
Niedersachsen
Country [65] 3563 0
Germany
State/province [65] 3563 0
Hessen
Country [66] 3564 0
South Africa
State/province [66] 3564 0
Kwa-Zulu Natal
Country [67] 3565 0
Puerto Rico
State/province [67] 3565 0
Country [68] 3566 0
Estonia
State/province [68] 3566 0
Country [69] 3567 0
Hong Kong
State/province [69] 3567 0
Country [70] 3568 0
Lithuania
State/province [70] 3568 0

Funding & Sponsors
Funding source category [1] 265000 0
Commercial sector/Industry
Name [1] 265000 0
UCB Inc.
Address [1] 265000 0
1950 Lake Park Drive, Smyrna GA 30080, USA
Country [1] 265000 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
UCB Inc
Address
1950 Lake Park Drive, Smyrna GA 30080, USA
Country
United States of America
Secondary sponsor category [1] 264091 0
None
Name [1] 264091 0
Address [1] 264091 0
Country [1] 264091 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266963 0
Leading Ethics Committee: CPP - Ile de France V1
Ethics committee address [1] 266963 0
10, Pavilion Jacquard, 47, Bd De L'Hopital
75651 Paris Cedex 13
Ethics committee country [1] 266963 0
France
Date submitted for ethics approval [1] 266963 0
Approval date [1] 266963 0
21/01/2011
Ethics approval number [1] 266963 0
CPP no: 113-10
Ethics committee name [2] 266964 0
Prof. Dr. J-M Maloteaux
Ethics committee address [2] 266964 0
Avenue Hippocrate 53-14, Tour Harvey -Niveau 0, 1200 Bruxelles;
Ethics committee country [2] 266964 0
Belgium
Date submitted for ethics approval [2] 266964 0
Approval date [2] 266964 0
21/02/2011
Ethics approval number [2] 266964 0
OM 003
Ethics committee name [3] 266965 0
Eticka Komise Revmatologickeho ustav
Ethics committee address [3] 266965 0
Na Stupi4, 128-50 Praha 2
Ethics committee country [3] 266965 0
Czech Republic
Date submitted for ethics approval [3] 266965 0
Approval date [3] 266965 0
21/12/2010
Ethics approval number [3] 266965 0
6044/2010-
Ethics committee name [4] 266966 0
National Institute of Pharmacy
Ethics committee address [4] 266966 0
H-1051, Budapest, Zrinyi03
H-1372 Budapest, POB:450
Ethics committee country [4] 266966 0
Hungary
Date submitted for ethics approval [4] 266966 0
Approval date [4] 266966 0
08/02/2011
Ethics approval number [4] 266966 0
OGYI/54703-6/2010
Ethics committee name [5] 266967 0
The Barzilai Medical Center
Ethics committee address [5] 266967 0
Ben-Gurion University of the Negen
Ethics committee country [5] 266967 0
Israel
Date submitted for ethics approval [5] 266967 0
Approval date [5] 266967 0
02/03/2011
Ethics approval number [5] 266967 0
1703
Ethics committee name [6] 266968 0
Helsinki Committee of Bnai Zion Medical Center
Ethics committee address [6] 266968 0
Bnai Zion Medical Center, 43 Golomb St. , Haifa 31048,
Ethics committee country [6] 266968 0
Israel
Date submitted for ethics approval [6] 266968 0
Approval date [6] 266968 0
21/01/2011
Ethics approval number [6] 266968 0
0149-10-BNZ
Ethics committee name [7] 266969 0
Pharma Ethics Ltd
Ethics committee address [7] 266969 0
123 Amcor Road, Lyttelton Manor 0157
Ethics committee country [7] 266969 0
South Africa
Date submitted for ethics approval [7] 266969 0
Approval date [7] 266969 0
07/03/2011
Ethics approval number [7] 266969 0
11014093
Ethics committee name [8] 266970 0
CEIC de Euskadi
Ethics committee address [8] 266970 0
Comittico de Investigacin Clinica de la Comunidad Aut noma del Pas Vasco. CEIC-E, Direccin de Farmacia del Departamento de Sanidad, C/ Donostia - San Sebastin, 1, 01010 Vitoria - Alava
Ethics committee country [8] 266970 0
Spain
Date submitted for ethics approval [8] 266970 0
Approval date [8] 266970 0
14/02/2011
Ethics approval number [8] 266970 0
NAP
Ethics committee name [9] 266971 0
Central Ethics Commission of Ministry of Health of Ukraine
Ethics committee address [9] 266971 0
Vul. Narodnogo opolchennia, 5, Kyiv, 03680 MSP
Ethics committee country [9] 266971 0
Ukraine
Date submitted for ethics approval [9] 266971 0
Approval date [9] 266971 0
16/03/2011
Ethics approval number [9] 266971 0
#5.12-282/KE
Ethics committee name [10] 266972 0
Ethics Committee Shalby Hospital
Ethics committee address [10] 266972 0
Shalby Hospital, Opp. Karnavati Club, S.G. Road, Ahmedabad-380015,Gujarat
Ethics committee country [10] 266972 0
India
Date submitted for ethics approval [10] 266972 0
Approval date [10] 266972 0
09/02/2011
Ethics approval number [10] 266972 0
NAP
Ethics committee name [11] 266973 0
Schulman Associates IRB, Inc.
Ethics committee address [11] 266973 0
4290 Glendale-Milford Road
Cincinnati, OH 45242
Ethics committee country [11] 266973 0
United States of America
Date submitted for ethics approval [11] 266973 0
Approval date [11] 266973 0
10/12/2010
Ethics approval number [11] 266973 0
201066940

Summary
Brief summary
This is a Phase 3, multicenter, open-label, extension study to evaluate the safety, tolerability, efficacy, and immunogenicity of long-term epratuzumab treatment in subjects with SLE.
Subjects who complete 1 of the Phase 3, double-blind, placebo controlled studies, SL0009 or SL0010, or terminate prematurely (at Week 16 or later) due to lack of efficacy, are eligible to enroll in SL0012.
The study consists of an Open-Label Treatment Period and a Safety Follow-Up Visit. During the Open-Label Treatment Period, all subjects will receive epratuzumab 600mg delivered QW via slow iv infusion for a total of 4 consecutive weeks (CMD 2400mg) over eight 12 week treatment cycles (ie, Weeks 0, 1, 2, 3, 12, 13, 14, 15, 24, 25, 26, 27, 36, 37, 38, 39, 48 (Year 1), 49, 50, 51, 60, 61, 62, 63, 72, 73, 74, 75, 84, 85, 86, and 87 (Year 2) [96 weeks total duration]). A Safety Follow-Up Visit will occur approximately 4 weeks after Week 96 (ie, no later than Week 100) for subjects who complete the study, or 13 weeks after the final dose of study drug for subjects who discontinue early.
Study drug treatment is in addition to the subjects’ existing standard care of oral corticosteroids and any immunosuppressants or antimalarials continued from Baseline in the subjects’ prior study.
Trial website
www.embodyprogram.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32561 0
Address 32561 0
Country 32561 0
Phone 32561 0
Fax 32561 0
Email 32561 0
Contact person for public queries
Name 15808 0
Dulce Lauterbach
Address 15808 0
PAREXEL International Pty Ltd
Suite B Level 6, 15 Talavera Road
North Ryde NSW 2113
Country 15808 0
Australia
Phone 15808 0
+61 2 8870 3100 (reception) +61 2 8870 3191 (direct)
Fax 15808 0
Email 15808 0
dulce.lauterbach@parexel.com
Contact person for scientific queries
Name 6736 0
Betsy Smith
Address 6736 0
Clinical Project Manager
UCB BioSciences, Inc.
8010 Arco Corporate Drive, Suite 100
Raleigh, NC 27617
Country 6736 0
United States of America
Phone 6736 0
+1 919 767 2619
Fax 6736 0
Email 6736 0
betsy.smith@ucb.com

No information has been provided regarding IPD availability
Summary results
No Results