Trial Review

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01262365




Registration number
NCT01262365
Ethics application status
Date submitted
14/12/2010
Date registered
17/12/2010
Date last updated
28/09/2018

Titles & IDs
Public title
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
Scientific 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
Secondary ID [1] 0 0
2010-018563-41
Secondary ID [2] 0 0
SL0009
Universal Trial Number (UTN)
Trial acronym
EMBODY1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Epratuzumab
Treatment: Drugs - Epratuzumab
Treatment: Drugs - Placebo

Placebo Comparator: Placebo (Weekly infusion) - Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles

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

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


Treatment: Drugs: Epratuzumab
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles

Treatment: Drugs: Epratuzumab
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles

Treatment: Drugs: Placebo
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
Timepoint [1] 0 0
At Week 48
Secondary outcome [1] 0 0
The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index
Timepoint [1] 0 0
At Week 24
Secondary outcome [2] 0 0
The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index
Timepoint [2] 0 0
At Week 12
Secondary outcome [3] 0 0
The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index
Timepoint [3] 0 0
At Week 36
Secondary outcome [4] 0 0
Change From Baseline in Daily Corticosteroid Dose at Week 24
Timepoint [4] 0 0
At Week 24
Secondary outcome [5] 0 0
Change From Baseline in Daily Corticosteroid Dose at Week 48
Timepoint [5] 0 0
At Week 48

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
793
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
426 - Maroochydore
Recruitment hospital [2] 0 0
425 - Malvern
Recruitment hospital [3] 0 0
429 - Camperdown
Recruitment hospital [4] 0 0
427 - Clayton
Recruitment hospital [5] 0 0
430 - Liverpool
Recruitment postcode(s) [1] 0 0
- Maroochydore
Recruitment postcode(s) [2] 0 0
- Malvern
Recruitment postcode(s) [3] 0 0
- Camperdown
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment postcode(s) [5] 0 0
- Liverpool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
Belgium
State/province [22] 0 0
Brussels
Country [23] 0 0
Belgium
State/province [23] 0 0
Leuven
Country [24] 0 0
Belgium
State/province [24] 0 0
Liege
Country [25] 0 0
Brazil
State/province [25] 0 0
Campinas
Country [26] 0 0
Brazil
State/province [26] 0 0
Porto Alegre
Country [27] 0 0
Brazil
State/province [27] 0 0
Recife
Country [28] 0 0
Brazil
State/province [28] 0 0
Rio de Janeiro
Country [29] 0 0
Brazil
State/province [29] 0 0
Salvador
Country [30] 0 0
Brazil
State/province [30] 0 0
Sao Paulo
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Plovdiv
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sofia
Country [33] 0 0
Czechia
State/province [33] 0 0
Olomouc
Country [34] 0 0
Czechia
State/province [34] 0 0
Praha 2
Country [35] 0 0
Czechia
State/province [35] 0 0
Zlin
Country [36] 0 0
Estonia
State/province [36] 0 0
Tallinn
Country [37] 0 0
France
State/province [37] 0 0
Lille
Country [38] 0 0
France
State/province [38] 0 0
Nantes
Country [39] 0 0
France
State/province [39] 0 0
Paris
Country [40] 0 0
France
State/province [40] 0 0
Pessac
Country [41] 0 0
Germany
State/province [41] 0 0
Berlin
Country [42] 0 0
Germany
State/province [42] 0 0
Frankfurt
Country [43] 0 0
Germany
State/province [43] 0 0
Freiburg
Country [44] 0 0
Germany
State/province [44] 0 0
Hannover
Country [45] 0 0
Germany
State/province [45] 0 0
Plochingen
Country [46] 0 0
India
State/province [46] 0 0
Bangalore
Country [47] 0 0
India
State/province [47] 0 0
Hyderabad
Country [48] 0 0
India
State/province [48] 0 0
Lucknow
Country [49] 0 0
Israel
State/province [49] 0 0
Ashkelon
Country [50] 0 0
Israel
State/province [50] 0 0
Beer Sheva
Country [51] 0 0
Israel
State/province [51] 0 0
Haifa
Country [52] 0 0
Israel
State/province [52] 0 0
Jerusalem
Country [53] 0 0
Israel
State/province [53] 0 0
Kfar Saba
Country [54] 0 0
Israel
State/province [54] 0 0
Rehovot
Country [55] 0 0
Israel
State/province [55] 0 0
Tel Aviv
Country [56] 0 0
Israel
State/province [56] 0 0
Tel-Hashomer
Country [57] 0 0
Italy
State/province [57] 0 0
Ferrara
Country [58] 0 0
Italy
State/province [58] 0 0
Padova
Country [59] 0 0
Italy
State/province [59] 0 0
Torino
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Busan
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Daegu
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Daejeon
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Incheon
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Jeonju
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Junggu
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Seoul
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Suwon
Country [68] 0 0
Lithuania
State/province [68] 0 0
Kaunas
Country [69] 0 0
Lithuania
State/province [69] 0 0
Klaipeda
Country [70] 0 0
Mexico
State/province [70] 0 0
Guadalajara
Country [71] 0 0
Mexico
State/province [71] 0 0
Mérida
Country [72] 0 0
Puerto Rico
State/province [72] 0 0
Cidra
Country [73] 0 0
Puerto Rico
State/province [73] 0 0
San Juan
Country [74] 0 0
Romania
State/province [74] 0 0
Brasov
Country [75] 0 0
Romania
State/province [75] 0 0
Bucharest
Country [76] 0 0
Romania
State/province [76] 0 0
Cluj-Napoca
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Ekaterinburg
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Petrozavodsk
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Saint Petersburg
Country [80] 0 0
Spain
State/province [80] 0 0
Santa Cruz De Tenerife
Country [81] 0 0
Spain
State/province [81] 0 0
Vizcaya
Country [82] 0 0
Spain
State/province [82] 0 0
Barcelona
Country [83] 0 0
Spain
State/province [83] 0 0
Madrid
Country [84] 0 0
Spain
State/province [84] 0 0
Malaga
Country [85] 0 0
Spain
State/province [85] 0 0
Santander
Country [86] 0 0
Spain
State/province [86] 0 0
Sevilla
Country [87] 0 0
Taiwan
State/province [87] 0 0
Changhua
Country [88] 0 0
Taiwan
State/province [88] 0 0
Chiayi City
Country [89] 0 0
Taiwan
State/province [89] 0 0
Kaohsiung
Country [90] 0 0
Taiwan
State/province [90] 0 0
Taichung
Country [91] 0 0
Taiwan
State/province [91] 0 0
Taipei
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Brighton
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Doncaster
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Leeds
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Romford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Pharma
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01262365
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCb Clinical Trial Call Center
Address 0 0
+1 877 822 9493 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01262365