Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

— EMBODY1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262365
• Other study ID #: SL0009
• Secondary ID: 2010-018563-41
• Status: Completed
• Phase: Phase 3
• Start date: December 2010
• Est. completion date: May 2015

Study information

• Verified date: June 2018
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 793
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Epratuzumab
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles
• Epratuzumab
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
• Placebo
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles

Locations

Country	Name	City	State
Australia	429	Camperdown
Australia	427	Clayton
Australia	430	Liverpool
Australia	425	Malvern	Victoria
Australia	426	Maroochydore	Queensland
Belgium	106	Brussels
Belgium	107	Brussels
Belgium	105	Leuven
Belgium	104	Liege
Brazil	455	Campinas
Brazil	453	Porto Alegre
Brazil	451	Recife
Brazil	450	Rio de Janeiro
Brazil	452	Salvador
Brazil	454	Sao Paulo
Bulgaria	201	Plovdiv
Bulgaria	200	Sofia
Bulgaria	202	Sofia
Bulgaria	203	Sofia
Bulgaria	204	Sofia
Bulgaria	205	Sofia
Czechia	218	Olomouc
Czechia	216	Praha 2
Czechia	215	Zlin
Estonia	226	Tallinn
France	113	Lille
France	114	Nantes
France	112	Paris
France	116	Pessac
Germany	127	Berlin
Germany	128	Frankfurt
Germany	126	Freiburg
Germany	130	Hannover
Germany	129	Plochingen
India	351	Bangalore
India	352	Hyderabad
India	350	Lucknow
Israel	378	Ashkelon
Israel	376	Beer Sheva
Israel	375	Haifa
Israel	377	Haifa
Israel	381	Jerusalem
Israel	382	Kfar Saba
Israel	380	Rehovot
Israel	379	Tel Aviv
Israel	383	Tel-Hashomer
Italy	149	Ferrara
Italy	148	Padova
Italy	147	Torino
Korea, Republic of	306	Busan
Korea, Republic of	303	Daegu
Korea, Republic of	309	Daegu
Korea, Republic of	308	Daejeon
Korea, Republic of	304	Incheon
Korea, Republic of	310	Jeonju
Korea, Republic of	301	Junggu
Korea, Republic of	307	Seoul
Korea, Republic of	302	Suwon
Lithuania	155	Kaunas
Lithuania	156	Klaipeda
Mexico	475	Guadalajara
Mexico	476	Guadalajara
Mexico	478	Guadalajara
Mexico	480	Mérida
Puerto Rico	091	Cidra
Puerto Rico	086	San Juan
Romania	263	Brasov
Romania	260	Bucharest
Romania	262	Bucharest
Romania	264	Bucharest
Romania	261	Cluj-Napoca
Russian Federation	281	Ekaterinburg
Russian Federation	285	Petrozavodsk
Russian Federation	284	Saint Petersburg
Spain	161	Barcelona
Spain	164	Bilbao	Vizcaya
Spain	165	La Laguna	Santa Cruz De Tenerife
Spain	162	Madrid
Spain	163	Madrid
Spain	166	Malaga
Spain	177	Santander
Spain	160	Sevilla
Taiwan	325	Changhua
Taiwan	326	Chiayi City
Taiwan	328	Kaohsiung
Taiwan	329	Taichung
Taiwan	330	Taipei
United Kingdom	178	Brighton
United Kingdom	182	Doncaster
United Kingdom	179	Leeds
United Kingdom	181	Romford
United States	048	Aurora	Colorado
United States	078	Austin	Texas
United States	098	Austin	Texas
United States	042	Aventura	Florida
United States	040	Baltimore	Maryland
United States	069	Birmingham	Alabama
United States	099	Charleston	South Carolina
United States	077	Charlotte	North Carolina
United States	052	Chicago	Illinois
United States	090	Clearwater	Florida
United States	037	Colorado Springs	Colorado
United States	001	Columbia	South Carolina
United States	061	Columbus	Ohio
United States	079	Dallas	Texas
United States	092	DeBary	Florida
United States	032	Duncansville	Pennsylvania
United States	058	Durham	North Carolina
United States	085	Escondido	California
United States	039	Farmington	Connecticut
United States	055	Houston	Texas
United States	096	Indianapolis	Indiana
United States	064	Jupiter	Florida
United States	067	Las Cruces	New Mexico
United States	044	Lawrenceville	Georgia
United States	063	Little Rock	Arkansas
United States	031	Los Angeles	California
United States	051	Los Angeles	California
United States	089	Los Angeles	California
United States	057	Memphis	Tennessee
United States	036	Mesquite	Texas
United States	082	Miami	Florida
United States	071	Middleburg Heights	Ohio
United States	053	New York	New York
United States	041	Oklahoma City	Oklahoma
United States	076	Oklahoma City	Oklahoma
United States	097	Oklahoma City	Oklahoma
United States	070	Ormond Beach	Florida
United States	084	Palm Harbor	Florida
United States	093	Philadelphia	Pennsylvania
United States	073	Pittsburgh	Pennsylvania
United States	094	Pittsburgh	Pennsylvania
United States	047	Saint Clair Shores	Michigan
United States	066	San Antonio	Texas
United States	074	San Diego	California
United States	80	San Gabriel	California
United States	060	Shreveport	Louisiana
United States	034	Simpsonville	South Carolina
United States	062	Tamarac	Florida
United States	050	Tampa	Florida
United States	087	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Bulgaria,  Czechia,  Estonia,  France,  Germany,  India,  Israel,  Italy,  Korea, Republic of,  Lithuania,  Mexico,  Puerto Rico,  Romania,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At Week 24
Secondary	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.	At Week 12
Secondary	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.	At Week 36
Secondary	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.	At Week 24
Secondary	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.	At Week 48