Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus (EMBODY4)

September 3, 2018 updated by: UCB Pharma

A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects

The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared accordingly.

Study Type

Interventional

Enrollment (Actual)

1250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Camperdown, Australia
        • 429
      • Clayton, Australia
        • 427
      • Liverpool, Australia
        • 430
      • Malvern, Australia
        • 425
      • Maroochydore, Australia
        • 426
  • Belgium
      • Brussels, Belgium
        • 106
      • Brussels, Belgium
        • 107
      • Leuven, Belgium
        • 105
      • Liege, Belgium
        • 104
  • Brazil
      • Belo Horizonte, Brazil
        • 954
      • Campinas, Brazil
        • 956
      • Goiânia, Brazil
        • 955
      • Juiz de Fora, Brazil
        • 950
      • Porto Alegre, Brazil
        • 453
      • Recife, Brazil
        • 451
      • Rio de Janeiro, Brazil
        • 952
      • Rio de Janeiro, Brazil
        • 450
      • Salvador, Brazil
        • 452
      • Sao Paulo, Brazil
        • 454
  • Bulgaria
      • Sofia, Bulgaria
        • 200
      • Sofia, Bulgaria
        • 202
      • Sofia, Bulgaria
        • 203
      • Sofia, Bulgaria
        • 204
      • Sofia, Bulgaria
        • 205
  • Canada
      • Hamilton, Canada
        • 502
      • Mississauga, Canada
        • 507
      • Rimouski, Canada
        • 508
      • St. John's, Canada
        • 506
      • Toronto, Canada
        • 504
    • Ontario
      • London, Ontario, Canada
        • 500
  • Czechia
      • Olomouc, Czechia
        • 218
      • Praha 2, Czechia
        • 216
      • Zlin, Czechia
        • 215
  • Estonia
      • Tallinn, Estonia
        • 226
  • France
      • Lille Cedex, France
        • 113
      • Limoges Cedex, France
        • 618
      • Montpellier Cedex 5, France
        • 617
      • Paris, France
        • 614
      • Pessac, France
        • 116
      • Toulouse Cedex 9, France
        • 616
  • Germany
      • Berlin, Germany
        • 628
      • Berlin, Germany
        • 633
      • Berlin, Germany
        • 127
      • Frankfurt, Germany
        • 128
      • Freiburg, Germany
        • 126
      • Hamburg, Germany
        • 637
      • Herne, Germany
        • 632
      • Koln, Germany
        • 625
      • Leipzig, Germany
        • 626
      • Mainz, Germany
        • 634
      • Munster, Germany
        • 627
      • Plochingen, Germany
        • 129
      • Roßlau, Germany
        • 636
      • Zerbst, Germany
        • 631
  • Hong Kong
      • Shatin, Hong Kong
        • 349
  • Hungary
      • Budapest, Hungary
        • 712
      • Budapest, Hungary
        • 716
      • Budapest, Hungary
        • 718
      • Debrecen, Hungary
        • 717
      • Szeged, Hungary
        • 711
      • Szeged, Hungary
        • 715
      • Zalaegerszeg, Hungary
        • 713
  • Israel
      • Ashkelon, Israel
        • 378
      • Beer Sheva, Israel
        • 376
      • Haifa, Israel
        • 375
      • Haifa, Israel
        • 377
      • Jerusalem, Israel
        • 381
      • Kfar Saba, Israel
        • 382
      • Rehovot, Israel
        • 380
      • Tel Aviv, Israel
        • 379
      • Tel-Hashomer, Israel
        • 383
  • Italy
      • Ferrara, Italy
        • 149
      • Milano, Italy
        • 648
      • Padova, Italy
        • 148
      • Pisa, Italy
        • 647
      • Roma, Italy
        • 646
      • Torino, Italy
        • 147
  • Korea, Republic of
      • Busan, Korea, Republic of
        • 306
      • Daegu, Korea, Republic of
        • 303
      • Daejeon, Korea, Republic of
        • 308
      • Incheon, Korea, Republic of
        • 301
      • Seoul, Korea, Republic of
        • 307
      • Suwon, Korea, Republic of
        • 302
  • Lithuania
      • Kaunas, Lithuania
        • 242
      • Klaipeda, Lithuania
        • 244
      • Vilnius, Lithuania
        • 243
  • Mexico
      • Guadalajara, Mexico
        • 478
      • Merida, Mexico
        • 480
      • Mexico City, Mexico
        • 976
      • Mexico City, Mexico
        • 982
      • Torreon, Mexico
        • 981
  • Poland
      • Bydgoszcz, Poland
        • 743
      • Czestochowa, Poland
        • 744
      • Elblag, Poland
        • 752
      • Elbląg, Poland
        • 754
      • Katowice, Poland
        • 746
      • Lublin, Poland
        • 748
      • Lublin, Poland
        • 750
      • Poznan, Poland
        • 742
      • Szczecin, Poland
        • 747
      • Ustron, Poland
        • 751
      • Warsaw, Poland
        • 749
  • Romania
      • Brasov, Romania
        • 263
      • Bucharest, Romania
        • 757
      • Bucharest, Romania
        • 758
      • Bucharest, Romania
        • 260
      • Bucharest, Romania
        • 262
      • Bucharest, Romania
        • 264
      • Cluj-Napoca, Romania
        • 261
      • Constanta, Romania
        • 759
      • Galati, Romania
        • 756
      • Iasi, Romania
        • 761
  • Russian Federation
      • Ekaterinburg, Russian Federation
        • 281
      • Moscow, Russian Federation
        • 779
      • Petrozavodsk, Russian Federation
        • 285
      • Saint Petersburg, Russian Federation
        • 284
  • South Africa
      • Cape Town, South Africa
        • 901
      • Durban, South Africa
        • 902
      • Stellenbosch, South Africa
        • 903
  • Spain
      • Barcelona, Spain
        • 661
      • Barcelona, Spain
        • 161
      • Bilbao, Spain
        • 164
      • Getafe, Spain
        • 660
      • La Laguna, Spain
        • 165
      • Las Palmas de Gran Canaria, Spain
        • 662
      • Madrid, Spain
        • 664
      • Madrid, Spain
        • 162
      • Madrid, Spain
        • 163
      • Malaga, Spain
        • 166
      • Santander, Spain
        • 177
      • Santiago de Compostela, Spain
        • 663
      • Sevilla, Spain
        • 160
      • Vigo, Spain
        • 659
  • Taiwan
      • Changhua, Taiwan
        • 325
      • Chiayi City, Taiwan
        • 326
      • Kaohsiung City, Taiwan
        • 328
      • Taipei, Taiwan
        • 330
  • Ukraine
      • Donetsk, Ukraine
        • 791
      • Ivano-Frankivsk, Ukraine
        • 799
      • Kiev, Ukraine
        • 790
      • Kiev, Ukraine
        • 794
      • Kiev, Ukraine
        • 797
      • Lugansk, Ukraine
        • 792
      • Odessa, Ukraine
        • 793
      • Vinnytsya, Ukraine
        • 796
  • United Kingdom
      • Birmingham, United Kingdom
        • 677
      • Brighton, United Kingdom
        • 178
      • Doncaster, United Kingdom
        • 182
      • Leeds, United Kingdom
        • 179
      • Romford, United Kingdom
        • 181
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 539
    • Arkansas
      • Little Rock, Arkansas, United States
        • 557
    • California
      • Hemet, California, United States
        • 515
      • Huntington Beach, California, United States
        • 544
      • La Jolla, California, United States
        • 550
      • Los Angeles, California, United States
        • 031
      • Los Angeles, California, United States
        • 051
      • Los Angeles, California, United States
        • 089
      • San Leandro, California, United States
        • 531
      • Thousand Oaks, California, United States
        • 594
      • Torrance, California, United States
        • 558
    • Colorado
      • Aurora, Colorado, United States
        • 048
      • Colorado Springs, Colorado, United States
        • 037
      • Denver, Colorado, United States
        • 532
    • Connecticut
      • Bridgeport, Connecticut, United States
        • 511
      • Farmington, Connecticut, United States
        • 039
    • Florida
      • Aventura, Florida, United States
        • 042
      • Brandon, Florida, United States
        • 514
      • Clearwater, Florida, United States
        • 090
      • DeBary, Florida, United States
        • 092
      • Fort Lauderdale, Florida, United States
        • 533
      • Jupiter, Florida, United States
        • 064
      • Ormond Beach, Florida, United States
        • 070
      • Palm Harbor, Florida, United States
        • 084
      • Plantation, Florida, United States
        • 518
      • Port Orange, Florida, United States
        • 585
      • Tampa, Florida, United States
        • 538
      • Tampa, Florida, United States
        • 050
      • Vero Beach, Florida, United States
        • 087
    • Georgia
      • Atlanta, Georgia, United States
        • 537
      • Duluth, Georgia, United States
        • 044
    • Idaho
      • Idaho Falls, Idaho, United States
        • 590
    • Illinois
      • Chicago, Illinois, United States
        • 052
    • Indiana
      • Indianapolis, Indiana, United States
        • 096
    • Louisiana
      • Shreveport, Louisiana, United States
        • 060
    • Michigan
      • Lansing, Michigan, United States
        • 513
      • Lansing, Michigan, United States
        • 599
      • Saint Clair Shores, Michigan, United States
        • 047
    • Missouri
      • Florissant, Missouri, United States
        • 575
      • Saint Louis, Missouri, United States
        • 549
    • New Hampshire
      • Nashua, New Hampshire, United States
        • 596
    • New Jersey
      • Freehold, New Jersey, United States
        • 568
      • Trenton, New Jersey, United States
        • 593
    • New Mexico
      • Las Cruces, New Mexico, United States
        • 067
    • New York
      • Brooklyn, New York, United States
        • 551
      • Great Neck, New York, United States
        • 553
      • Manhasset, New York, United States
        • 545
      • New York, New York, United States
        • 053
      • Roslyn, New York, United States
        • 577
    • North Carolina
      • Charlotte, North Carolina, United States
        • 559
      • Charlotte, North Carolina, United States
        • 077
      • Durham, North Carolina, United States
        • 058
      • Wilmington, North Carolina, United States
        • 075
    • Ohio
      • Columbus, Ohio, United States
        • 061
      • Middleburg Heights, Ohio, United States
        • 071
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 041
      • Oklahoma City, Oklahoma, United States
        • 076
      • Oklahoma City, Oklahoma, United States
        • 097
      • Tulsa, Oklahoma, United States
        • 547
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
        • 032
      • Philadelphia, Pennsylvania, United States
        • 093
      • Pittsburgh, Pennsylvania, United States
        • 073
      • Pittsburgh, Pennsylvania, United States
        • 094
    • South Carolina
      • Charleston, South Carolina, United States
        • 535
      • Myrtle Beach, South Carolina, United States
        • 598
    • Tennessee
      • Jackson, Tennessee, United States
        • 571
      • Memphis, Tennessee, United States
        • 057
    • Texas
      • Amarillo, Texas, United States
        • 574
      • Austin, Texas, United States
        • 570
      • Austin, Texas, United States
        • 078
      • Austin, Texas, United States
        • 098
      • Dallas, Texas, United States
        • 079
      • Houston, Texas, United States
        • 541
      • Houston, Texas, United States
        • 563
      • Mesquite, Texas, United States
        • 036
      • San Antonio, Texas, United States
        • 562
      • San Antonio, Texas, United States
        • 066
    • Washington
      • Seattle, Washington, United States
        • 534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010 (NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
  • Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881), and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
  • Women of childbearing potential must agree to use an acceptable method of birth control

Exclusion Criteria:

  • Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease
  • Subjects with active, severe SLE disease activity which involves the renal system
  • Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
  • Substance abuse or dependence
  • History of malignant cancer
  • Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epratuzumab 600 mg per week
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Drug: Epratuzumab
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles
Drug: Epratuzumab
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 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 sixteen 12 week treatment cycles
Drug: Epratuzumab
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles
Drug: Epratuzumab
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
Time Frame: During the treatment period (through Week 96)
A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
During the treatment period (through Week 96)
Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
Time Frame: During the treatment period (through Week 96)
A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
During the treatment period (through Week 96)
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
Time Frame: During the treatment period (through Week 96)

A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes:

  • Death
  • Life-threatening
  • Significant or persistent disability/incapacity
  • Congenital anomaly/birth defect (including that occurring in a fetus)
  • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
  • Initial inpatient hospitalization or prolongation of hospitalization
During the treatment period (through Week 96)
Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
Time Frame: During the treatment period (through Week 96)

A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes:

  • Death
  • Life-threatening
  • Significant or persistent disability/incapacity
  • Congenital anomaly/birth defect (including that occurring in a fetus)
  • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
  • Initial inpatient hospitalization or prolongation of hospitalization
During the treatment period (through Week 96)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Time Frame: At Week 48
Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
At Week 48
Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Time Frame: Week 48
Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
Week 48
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Time Frame: Week 96
Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
Week 96
The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Time Frame: Week 96
Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

August 1, 2011

First Submitted That Met QC Criteria

August 1, 2011

First Posted (Estimate)

August 3, 2011

Study Record Updates

Last Update Posted (Actual)

October 3, 2018

Last Update Submitted That Met QC Criteria

September 3, 2018

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL0012
  • 2010-020859-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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