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

Systemic Lupus Erythematosus Clinical Trial

— EMBODY2  

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: NCT01261793
• Other study ID #: SL0010
• Secondary ID: 2010-018565-26
• Status: Completed
• Phase: Phase 3
• Start date: December 2010
• Est. completion date: June 2015

Study information

• Verified date: November 2020
• 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: 791
• Est. completion date: June 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 SLE disease activity index (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:
• Placebo
Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
• 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

Locations

Country	Name	City	State
Brazil	954	Belo Horizonte
Brazil	956	Campinas
Brazil	955	Goiânia
Brazil	950	Juiz de Fora
Brazil	952	Rio de Janeiro
Canada	502	Hamilton
Canada	500	London
Canada	507	Mississauga	Ontario
Canada	508	Rimouski	Quebec
Canada	506	St. John's	Newfoundland and Labrador
Canada	504	Toronto
Canada	517	Victoria
France	613	Caen
France	618	Limoges Cedex
France	617	Montpellier Cedex 5
France	614	Paris
France	616	Toulouse Cedex 9
Germany	628	Berlin
Germany	633	Berlin
Germany	636	Dessau
Germany	637	Hamburg
Germany	632	Herne
Germany	629	Kiel
Germany	625	Köln
Germany	626	Leipzig
Germany	634	Mainz
Germany	627	Münster
Germany	639	Wiesbaden
Germany	631	Zerbst
Hungary	712	Budapest
Hungary	716	Budapest
Hungary	718	Budapest
Hungary	717	Debrecen
Hungary	711	Szeged
Hungary	715	Szeged
Hungary	713	Zalaegerszeg
India	852	Ahmedabad
India	853	Bangalore
Italy	648	Milano
Italy	647	Pisa
Italy	646	Roma
Mexico	978	Cuauhtémoc
Mexico	982	Mexico
Mexico	976	Mexico City
Mexico	981	Torreon
Poland	743	Bydgoszcz
Poland	744	Czestochowa
Poland	752	Elblag
Poland	745	Katowice
Poland	746	Katowice
Poland	748	Lublin
Poland	750	Lublin
Poland	742	Poznan
Poland	747	Szczecin
Poland	751	Ustron
Poland	749	Warsaw
Romania	757	Bucharest
Romania	758	Bucharest
Romania	760	Bucharest
Romania	759	Constanta
Romania	756	Galati
Romania	761	Iasi
Russian Federation	778	Kemerovo
Russian Federation	780	Kemerovo
Russian Federation	779	Moscow
South Africa	901	Cape Town
South Africa	902	Durban
South Africa	903	Stellenbosch
Spain	661	Barcelona
Spain	660	Getafe
Spain	662	Las Palmas de Gran Canaria
Spain	664	Madrid
Spain	663	Santiago de Compostela
Spain	659	Vigo
Ukraine	791	Donetsk
Ukraine	790	Kiev
Ukraine	794	Kiev
Ukraine	797	Kiev
Ukraine	792	Luhansk
Ukraine	793	Odessa
Ukraine	796	Vinnytsya
United Kingdom	677	Birmingham
United Kingdom	678	Christchurch
United Kingdom	679	London
United States	574	Amarillo	Texas
United States	554	Ann Arbor	Michigan
United States	537	Atlanta	Georgia
United States	570	Austin	Texas
United States	539	Birmingham	Alabama
United States	572	Boston	Massachusetts
United States	543	Bowling Green	Kentucky
United States	514	Brandon	Florida
United States	511	Bridgeport	Connecticut
United States	551	Brooklyn	New York
United States	535	Charleston	South Carolina
United States	559	Charlotte	North Carolina
United States	552	Chesapeake	Virginia
United States	593	Clifton	New Jersey
United States	587	Decatur	Georgia
United States	532	Denver	Colorado
United States	575	Florissant	Missouri
United States	533	Fort Lauderdale	Florida
United States	568	Freehold	New Jersey
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	571	Jackson	Tennessee
United States	550	La Jolla	California
United States	553	Lake Success	New York
United States	513	Lansing	Michigan
United States	599	Lansing	Michigan
United States	592	Lexington	Kentucky
United States	557	Little Rock	Arkansas
United States	548	Los Angeles	California
United States	545	Manhasset	New York
United States	598	Myrtle Beach	South Carolina
United States	596	Nashua	New Hampshire
United States	576	New Orleans	Louisiana
United States	518	Plantation	Florida
United States	585	Port Orange	Florida
United States	577	Roslyn	New York
United States	549	Saint Louis	Missouri
United States	562	San Antonio	Texas
United States	589	San Diego	California
United States	531	San Leandro	California
United States	534	Seattle	Washington
United States	538	Tampa	Florida
United States	558	Torrance	California
United States	547	Tulsa	Oklahoma
United States	594	Westlake Village	California
United States	561	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  France,  Germany,  Hungary,  India,  Italy,  Mexico,  Poland,  Romania,  Russian Federation,  South Africa,  Spain,  Ukraine,  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 (FAS). 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 (FAS). 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 (FAS). 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 (FAS). 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	Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to =50%, No change in dose and Dose increased or missing data.	At Week 24
Secondary	Change From Baseline in Daily Corticosteroid Dose at Week 48	Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to =50%, No change in dose and Dose increased or missing data.	At Week 48