Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)

• Register: EUCTR
• Last refreshed on: 4 August 2015
• Main ID: EUCTR2010-018565-26-HU
• Date of registration: 22/11/2010
• Prospective Registration: Yes
• Primary sponsor: UCB Inc.
• Public title: Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)
• Scientific 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 (EMBODY 2) - EMBODY 2
• Date of first enrolment: 16/01/2011
• Target sample size: 780
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018565-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Brazil, Canada, Germany, Hungary, India, Italy, Mexico, Russian Federation, South Africa, Spain, Ukraine, United Kingdom

Contacts

• Name: Clin Trial Reg & Results disclosure
• Affiliation: UCB BIOSCIENCES GmbH

• Name: Clin Trial Reg & Results disclosure
• Affiliation: UCB BIOSCIENCES GmbH

Key inclusion & exclusion criteria

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 randomization (Visit 2)
- Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
- Subject has previously received epratuzumab treatment.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Body processes [G] - Immune system processes [G12]

Systemic Lupus Erythmatosus
MedDRA version: 17.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: Epratuzumab
Product Code: CDP3194
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Epratuzumab
CAS Number: 205923-57-5
Current Sponsor code: CDP3194
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Secondary Objective: The secondary objectives of the study are to assess the safety, tolerability, and immunogenicity of epratuzumab, and to assess the steroid-sparing effects of epratuzumab treatment.

Main Objective: The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with moderate to severe general SLE despite standard of care treatments (ie, corticosteroids, and potentially antimalarials and immunosuppressants) continued from Baseline.

Timepoint(s) of evaluation of this end point: 48 weeks

Primary end point(s): The percent of subjects meeting treatment response criteria at Week 48 according to a combined response index.

Secondary Outcome(s)

Secondary end point(s): a) The percent of subjects meeting treatment response criteria at Week 24, according to the combined index.
b) The percent of subjects meeting treatment response criteria at Week 12, according to the combined index.
c) The percent of subjects meeting treatment response criteria at Week 36, according to the combined index.
d) Change from Baseline in daily corticosteroid dose at Week 24
e) Change from Baseline in daily corticosteroid dose at Week 48

Timepoint(s) of evaluation of this end point: a) 24 weeks
b) 12 weeks
c) 36 weeks
d) Baseline - 24 weeks
e) Baseline - 48 weeks

Secondary ID(s)

SL0010

Source(s) of Monetary Support

UCB Inc.