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

Systemic Lupus Erythematosus Clinical Trial

— EMBODY4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408576
• Other study ID #: SL0012
• Secondary ID: 2010-020859-30
• Status: Completed
• Phase: Phase 3
• Start date: July 2011
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1250
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Czechia,  Estonia,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Korea, Republic of,  Lithuania,  Mexico,  Poland,  Romania,  Russian Federation,  South Africa,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During the treatment period (through Week 96)
Primary	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.	During the treatment period (through Week 96)
Primary	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	During the treatment period (through Week 96)
Primary	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	During the treatment period (through Week 96)
Secondary	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.	At Week 48
Secondary	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.	Week 48
Secondary	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.	Week 96
Secondary	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.	Week 96