Systemic Lupus ErythematosusPhase 3EMBODY4NCT01408576
Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
A Phase 3 study testing Epratuzumab in people with Systemic Lupus Erythematosus, run by UCB Pharma at 228 sites in 25 countries.
Trial summary
The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Epratuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 228 sitesin 25 countries
- Study dates
- Jul 2011to Feb 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
228 sites in 25 countries.
228 sites in 25 countries
United States78 sites
574
Amarillo, Texas
537
Atlanta, Georgia
048
Aurora, Colorado
078
Austin, Texas
098
Austin, Texas
570
Austin, Texas
042
Aventura, Florida
539
Birmingham, Alabama
514
Brandon, Florida
511
Bridgeport, Connecticut
551
Brooklyn, New York
535
Charleston, South Carolina
077
Charlotte, North Carolina
559
Charlotte, North Carolina
052
Chicago, Illinois
090
Clearwater, Florida
037
Colorado Springs, Colorado
061
Columbus, Ohio
079
Dallas, Texas
092
DeBary, Florida
532
Denver, Colorado
044
Duluth, Georgia
032
Duncansville, Pennsylvania
058
Durham, North Carolina
039
Farmington, Connecticut
575
Florissant, Missouri
533
Fort Lauderdale, Florida
568
Freehold, New Jersey
553
Great Neck, New York
515
Hemet, California
541
Houston, Texas
563
Houston, Texas
544
Huntington Beach, California
590
Idaho Falls, Idaho
096
Indianapolis, Indiana
571
Jackson, Tennessee
064
Jupiter, Florida
550
La Jolla, California
513
Lansing, Michigan
599
Lansing, Michigan
067
Las Cruces, New Mexico
557
Little Rock, Arkansas
031
Los Angeles, California
051
Los Angeles, California
089
Los Angeles, California
545
Manhasset, New York
057
Memphis, Tennessee
036
Mesquite, Texas
071
Middleburg Heights, Ohio
598
Myrtle Beach, South Carolina
596
Nashua, New Hampshire
053
New York, New York
041
Oklahoma City, Oklahoma
076
Oklahoma City, Oklahoma
097
Oklahoma City, Oklahoma
070
Ormond Beach, Florida
084
Palm Harbor, Florida
093
Philadelphia, Pennsylvania
073
Pittsburgh, Pennsylvania
094
Pittsburgh, Pennsylvania
518
Plantation, Florida
585
Port Orange, Florida
577
Roslyn, New York
047
Saint Clair Shores, Michigan
066
San Antonio, Texas
562
San Antonio, Texas
531
San Leandro, California
534
Seattle, Washington
060
Shreveport, Louisiana
549
St Louis, Missouri
050
Tampa, Florida
538
Tampa, Florida
594
Thousand Oaks, California
558
Torrance, California
593
Trenton, New Jersey
547
Tulsa, Oklahoma
087
Vero Beach, Florida
075
Wilmington, North Carolina
Germany14 sites
127
Berlin
628
Berlin
633
Berlin
625
Cologne
128
Frankfurt
126
Freiburg im Breisgau
637
Hamburg
632
Herne
626
Leipzig
634
Mainz
627
Münster
129
Plochingen
636
Roßlau
631
Zerbst
Spain14 sites
161
Barcelona
661
Barcelona
164
Bilbao
660
Getafe
662
Las Palmas de Gran Canaria
162
Madrid
163
Madrid
664
Madrid
166
Málaga
165
San Cristóbal de La Laguna
177
Santander
663
Santiago de Compostela
160
Seville
659
Vigo
Poland11 sites
743
Bydgoszcz
744
Częstochowa
752
Elblag
754
Elblag
746
Katowice
748
Lublin
750
Lublin
742
Poznan
747
Szczecin
751
Ustroń
749
Warsaw
Brazil10 sites
954
Belo Horizonte
956
Campinas
955
Goiânia
950
Juiz de Fora
453
Porto Alegre
451
Recife
450
Rio de Janeiro
952
Rio de Janeiro
452
Salvador
454
São Paulo
Romania10 sites
263
Brasov
260
Bucharest
262
Bucharest
264
Bucharest
757
Bucharest
758
Bucharest
261
Cluj-Napoca
759
Constanța
756
Galati
761
Iași
Israel9 sites
378
Ashkelon
376
Beersheba
375
Haifa
377
Haifa
381
Jerusalem
382
Kfar Saba
380
Rehovot
379
Tel Aviv
383
Tel HaShomer
Ukraine8 sites
791
Donetsk
799
Ivano-Frankivsk
790
Kiev
794
Kiev
797
Kiev
792
Luhansk
793
Odesa
796
Vinnytsia
Hungary7 sites
712
Budapest
716
Budapest
718
Budapest
717
Debrecen
711
Szeged
715
Szeged
713
Zalaegerszeg
Canada6 sites
502
Hamilton
500
London, Ontario
507
Mississauga
508
Rimouski
506
St. John's
504
Toronto
France6 sites
113
Lille
618
Limoges
617
Montpellier
614
Paris
116
Pessac
616
Toulouse
South Korea6 sites
306
Busan
303
Daegu
308
Daejeon
301
Incheon
307
Seoul
302
Suwon
Australia5 sites
429
Camperdown
427
Clayton
430
Liverpool
425
Malvern
426
Maroochydore
Mexico5 sites
478
Guadalajara
480
Mérida
976
Mexico City
982
Mexico City
981
Torreón
United Kingdom5 sites
677
Birmingham
178
Brighton
182
Doncaster
179
Leeds
181
Romford
About this study
Official title: 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)
Read the detailed description
Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared accordingly.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Epratuzumab
- Keywords
- Lupus, Monoclonal antibody, B-Cell immunotherapy, Epratuzumab
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpratuzumabDrug
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles
EpratuzumabDrug
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles
| Study group | Role | What they receive |
|---|---|---|
| Epratuzumab 600 mg per week | Experimental | 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles Receives: Drug: Epratuzumab |
| Epratuzumab 1200 mg every other week | Experimental | 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles Receives: Drug: Epratuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
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.
Measured: 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)
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.
Measured: 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)
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
Measured: 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)
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
Measured: During the treatment period (through Week 96)
Secondary outcomes (4)
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
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.
Measured: At Week 48
Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
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.
Measured: Week 48
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
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.
Measured: Week 96
The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
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.
Measured: Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408576
- Sponsor's protocol ID
- SL0012
- Other IDs
- 2010-020859-30
- Acronym
- EMBODY4
- Status last verified
- Mar 2016
- First submitted
- 1 Aug 2011
- Last updated
- 3 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects
- ClinicalTrials.gov ID
- NCT01408576
- Acronym / sponsor ID
- EMBODY4 / SL0012
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, Monoclonal antibody, B-Cell immunotherapy, Epratuzumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Posted 3 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)
Detailed description
Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared accordingly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epratuzumab 600 mg per week | Experimental | Drug: Epratuzumab600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles |
| Epratuzumab 1200 mg every other week | Experimental | Drug: Epratuzumab1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epratuzumab600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles | Drug | Epratuzumab 600 mg per week |
| Epratuzumab1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles | Drug | Epratuzumab 1200 mg every other week |
Primary outcome
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.
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.
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
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
4 secondary outcomes
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Time frame: At Week 48
Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Time frame: Week 48
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Time frame: Week 96
The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Time frame: Week 96
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Dapagliflozin in Active Lupus Nephritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
UCB Pharma
228 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epratuzumab in people with Systemic Lupus Erythematosus, run by UCB Pharma at 228 sites in 25 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 228 sites in United States, Germany, Spain, Poland, Brazil and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.