Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
EMBODY1
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
2 other identifiers
interventional
793
20 countries
133
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2010
Typical duration for phase_3
133 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 14, 2010
CompletedFirst Posted
Study publicly available on registry
December 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
June 29, 2018
CompletedSeptember 28, 2018
June 1, 2018
4.4 years
December 14, 2010
May 30, 2018
August 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At Week 48
Secondary Outcomes (5)
The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index
At Week 24
The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index
At Week 12
The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index
At Week 36
Change From Baseline in Daily Corticosteroid Dose at Week 24
At Week 24
Change From Baseline in Daily Corticosteroid Dose at Week 48
At Week 48
Study Arms (3)
Placebo (Weekly infusion)
PLACEBO COMPARATORPlacebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
Epratuzumab 600 mg per week
EXPERIMENTAL600 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
EXPERIMENTAL1200 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
Interventions
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (141)
069
Birmingham, Alabama, United States
063
Little Rock, Arkansas, United States
085
Escondido, California, United States
031
Los Angeles, California, United States
051
Los Angeles, California, United States
089
Los Angeles, California, United States
074
San Diego, California, United States
80
San Gabriel, California, United States
048
Aurora, Colorado, United States
037
Colorado Springs, Colorado, United States
039
Farmington, Connecticut, United States
042
Aventura, Florida, United States
090
Clearwater, Florida, United States
092
DeBary, Florida, United States
064
Jupiter, Florida, United States
082
Miami, Florida, United States
070
Ormond Beach, Florida, United States
084
Palm Harbor, Florida, United States
062
Tamarac, Florida, United States
050
Tampa, Florida, United States
087
Vero Beach, Florida, United States
044
Lawrenceville, Georgia, United States
052
Chicago, Illinois, United States
096
Indianapolis, Indiana, United States
060
Shreveport, Louisiana, United States
040
Baltimore, Maryland, United States
047
Saint Clair Shores, Michigan, United States
067
Las Cruces, New Mexico, United States
053
New York, New York, United States
077
Charlotte, North Carolina, United States
058
Durham, North Carolina, United States
061
Columbus, Ohio, United States
071
Middleburg Heights, Ohio, United States
041
Oklahoma City, Oklahoma, United States
076
Oklahoma City, Oklahoma, United States
097
Oklahoma City, Oklahoma, United States
032
Duncansville, Pennsylvania, United States
093
Philadelphia, Pennsylvania, United States
073
Pittsburgh, Pennsylvania, United States
094
Pittsburgh, Pennsylvania, United States
099
Charleston, South Carolina, United States
001
Columbia, South Carolina, United States
034
Simpsonville, South Carolina, United States
057
Memphis, Tennessee, United States
078
Austin, Texas, United States
098
Austin, Texas, United States
079
Dallas, Texas, United States
055
Houston, Texas, United States
036
Mesquite, Texas, United States
066
San Antonio, Texas, United States
426
Maroochydore, Queensland, Australia
425
Malvern, Victoria, Australia
429
Camperdown, Australia
427
Clayton, Australia
430
Liverpool, Australia
106
Brussels, Belgium
107
Brussels, Belgium
105
Leuven, Belgium
104
Liège, Belgium
455
Campinas, Brazil
453
Porto Alegre, Brazil
451
Recife, Brazil
450
Rio de Janeiro, Brazil
452
Salvador, Brazil
454
São Paulo, Brazil
201
Plovdiv, Bulgaria
200
Sofia, Bulgaria
202
Sofia, Bulgaria
203
Sofia, Bulgaria
204
Sofia, Bulgaria
205
Sofia, Bulgaria
218
Olomouc, Czechia
216
Prague, Czechia
215
Zlín, Czechia
226
Tallinn, Estonia
113
Lille, France
114
Nantes, France
112
Paris, France
116
Pessac, France
127
Berlin, Germany
128
Frankfurt, Germany
126
Freiburg im Breisgau, Germany
130
Hanover, Germany
129
Plochingen, Germany
351
Bangalore, India
352
Hyderabad, India
350
Lucknow, India
378
Ashkelon, Israel
376
Beersheba, Israel
375
Haifa, Israel
377
Haifa, Israel
381
Jerusalem, Israel
382
Kfar Saba, Israel
380
Rehovot, Israel
379
Tel Aviv, Israel
383
Tel Litwinsky, Israel
149
Ferrara, Italy
148
Padua, Italy
147
Torino, Italy
155
Kaunas, Lithuania
156
Klaipėda, Lithuania
475
Guadalajara, Mexico
476
Guadalajara, Mexico
478
Guadalajara, Mexico
480
Mérida, Mexico
091
Cidra, Puerto Rico
086
San Juan, Puerto Rico
263
Brasov, Romania
260
Bucharest, Romania
262
Bucharest, Romania
264
Bucharest, Romania
261
Cluj-Napoca, Romania
285
Petrozavodsk, Russia
284
Saint Petersburg, Russia
281
Yekaterinburg, Russia
306
Busan, South Korea
303
Daegu, South Korea
309
Daegu, South Korea
308
Daejeon, South Korea
304
Incheon, South Korea
310
Jeonju, South Korea
301
Junggu, South Korea
307
Seoul, South Korea
302
Suwon, South Korea
165
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
164
Bilbao, Vizcaya, Spain
161
Barcelona, Spain
162
Madrid, Spain
163
Madrid, Spain
166
Málaga, Spain
177
Santander, Spain
160
Seville, Spain
325
Changhua, Taiwan
326
Chiayi City, Taiwan
328
Kaohsiung City, Taiwan
329
Taichung, Taiwan
330
Taipei, Taiwan
178
Brighton, United Kingdom
182
Doncaster, United Kingdom
179
Leeds, United Kingdom
181
Romford, United Kingdom
Related Publications (2)
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.
PMID: 29381843DERIVEDClowse 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.
PMID: 27598855DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCb Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2010
First Posted
December 17, 2010
Study Start
December 1, 2010
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
September 28, 2018
Results First Posted
June 29, 2018
Record last verified: 2018-06