Systemic Lupus ErythematosusPhase 3EMBODY1NCT01262365
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
A Phase 3 study testing Epratuzumab in people with Systemic Lupus Erythematosus, run by UCB Pharma at 141 sites in 21 countries.
Trial 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) 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?
- Yes, some participants may receive a placebo
- How many people
- 793 participants
- Where
- 141 sitesin 21 countries
- Study dates
- Dec 2010to May 2015
- 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
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
141 sites in 21 countries.
141 sites in 21 countries
United States50 sites
048
Aurora, Colorado
078
Austin, Texas
098
Austin, Texas
042
Aventura, Florida
040
Baltimore, Maryland
069
Birmingham, Alabama
099
Charleston, South Carolina
077
Charlotte, North Carolina
052
Chicago, Illinois
090
Clearwater, Florida
037
Colorado Springs, Colorado
001
Columbia, South Carolina
061
Columbus, Ohio
079
Dallas, Texas
092
DeBary, Florida
032
Duncansville, Pennsylvania
058
Durham, North Carolina
085
Escondido, California
039
Farmington, Connecticut
055
Houston, Texas
096
Indianapolis, Indiana
064
Jupiter, Florida
067
Las Cruces, New Mexico
044
Lawrenceville, Georgia
063
Little Rock, Arkansas
031
Los Angeles, California
051
Los Angeles, California
089
Los Angeles, California
057
Memphis, Tennessee
036
Mesquite, Texas
082
Miami, Florida
071
Middleburg Heights, Ohio
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
047
Saint Clair Shores, Michigan
066
San Antonio, Texas
074
San Diego, California
80
San Gabriel, California
060
Shreveport, Louisiana
034
Simpsonville, South Carolina
062
Tamarac, Florida
050
Tampa, Florida
087
Vero Beach, Florida
Israel9 sites
378
Ashkelon
376
Beersheba
375
Haifa
377
Haifa
381
Jerusalem
382
Kfar Saba
380
Rehovot
379
Tel Aviv
383
Tel HaShomer
South Korea9 sites
306
Busan
303
Daegu
309
Daegu
308
Daejeon
304
Incheon
310
Jeonju
301
Junggu
307
Seoul
302
Suwon
Spain8 sites
161
Barcelona
164
Bilbao, Vizcaya
162
Madrid
163
Madrid
166
Málaga
165
San Cristóbal de La Laguna, Santa Cruz De Tenerife
177
Santander
160
Seville
Brazil6 sites
455
Campinas
453
Porto Alegre
451
Recife
450
Rio de Janeiro
452
Salvador
454
São Paulo
Australia5 sites
429
Camperdown
427
Clayton
430
Liverpool
425
Malvern, Victoria
426
Maroochydore, Queensland
Germany5 sites
127
Berlin
128
Frankfurt
126
Freiburg im Breisgau
130
Hanover
129
Plochingen
Romania5 sites
263
Brasov
260
Bucharest
262
Bucharest
264
Bucharest
261
Cluj-Napoca
Taiwan5 sites
325
Changhua
326
Chiayi City
328
Kaohsiung City
329
Taichung
330
Taipei
About this study
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
The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Epratuzumab, Placebo
- 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 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles
EpratuzumabDrug
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
PlaceboDrug
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Weekly infusion) | Placebo comparator | Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles Receives: Drug: Placebo |
| Epratuzumab 600 mg per week | Experimental | 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 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 four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles Receives: Drug: Epratuzumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
Measured: At Week 48
Secondary outcomes (5)
The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
Measured: At Week 24
The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
Measured: At Week 12
The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
Measured: At Week 36
Change From Baseline in Daily Corticosteroid Dose at Week 24
Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.
Measured: At Week 24
Change From Baseline in Daily Corticosteroid Dose at Week 48
Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.
Measured: At Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMay 2015
- Study completionMay 2015
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 793 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, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262365
- Sponsor's protocol ID
- SL0009
- Other IDs
- 2010-018563-41
- Acronym
- EMBODY1
- Status last verified
- Jun 2018
- First submitted
- 14 Dec 2010
- Last updated
- 28 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29381843Clowse 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.
PubMed 27598855
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01262365
- Acronym / sponsor ID
- EMBODY1 / SL0009
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, Monoclonal antibody, B-Cell immunotherapy, Epratuzumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 793 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Posted 29 Jun 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 to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo (Weekly infusion) | Placebo comparator | Drug: PlaceboPlacebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles |
| Epratuzumab 600 mg per week | Experimental | Drug: Epratuzumab600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles |
| Epratuzumab 1200 mg every other week | Experimental | Drug: Epratuzumab, Drug: Placebo1200 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 weeks (cumulative dose 2400 mg) over four 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 four 12-week treatment cycles | Drug | Epratuzumab 1200 mg every other week |
| PlaceboPlacebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles | Drug | Epratuzumab 1200 mg every other week, Placebo (Weekly infusion) |
Primary outcome
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
Time frame: At Week 48
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
5 secondary outcomes
The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index
Time frame: At Week 24
The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index
Time frame: At Week 12
The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index
Time frame: At Week 36
Change From Baseline in Daily Corticosteroid Dose at Week 24
Time frame: At Week 24
Change From Baseline in Daily Corticosteroid Dose at Week 48
Time frame: At Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29381843Gottenberg 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.
- Derived from this study: PubMed 27598855Clowse 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.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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
+1 877 822 9493 (UCB)
141 sites in 21 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 141 sites in 21 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 5 inclusion and 14 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 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 141 sites in United States, Israel, South Korea, Spain, Brazil and 16 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. Some participants in this study may receive a placebo. 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 29 Jun 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?
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index (time frame: At Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01262365, which also lists 2 linked publications.
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 28 Sep 2018.