Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

• Register: EUCTR
• Last refreshed on: 8 August 2016
• Main ID: EUCTR2010-020859-30-BE
• Date of registration: 19/11/2010
• Prospective Registration: Yes
• Primary sponsor: UCB Inc.
• Public title: Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)
• Scientific title: A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4
• Date of first enrolment: 25/05/2011
• Target sample size: 1250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020859-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

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:
- The subject has completed double-blind study SL0009 or SL0010, or the subject has terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy, as described in the respective protocols and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment in SL0012. The subject has completed open-label study SL0006 or SL0008, and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment in SL0012.
- Woman of childbearing potential using an acceptable method of birth control.
- Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for a period of 3 months after their final dose of study drug.
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 1215
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion criteria:
- Subject has active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
- Subject has active, severe, SLE disease activity which involves the renal system defined by BILAG renal level A activity.
- Evidence of an immunosuppressive state.
- Subjects with a history of chronic infections, including but not limited to subjects with concurrent acute or chronic viral hepatitis B or C.
- Subjects with substance abuse/dependence or other concurrent medical conditions.
- History of malignant cancer.
- Subjects receiving any biological therapy after ending their participation in SL0006, SL0008, SL0009, or SL0010.
- Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study.
- Subjects with significant hematologic abnormalities, such as hemoglobin <8.0 g/dL, or WBC <2000/mm3, or absolute neutrophil count <1500/mm3, or platelets <30,000/mm3, at the last visit of SL0006, SL0008, SL0009, or SL0010 may be included in the study only after discussion with and approval of the medical monitor (the laboratory results from SL0009 and SL0010 should not be older than 28 days).


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

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus
MedDRA version: 18.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

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

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-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 96 and 192 weeks

Main Objective: The primary objective of the study is to assess the safety and tolerability of long-term epratuzumab treatment in subjects with SLE.

Primary end point(s): The percent of subjects meeting treatment response criteria at Week 96 and Week 192 according to a combined response index.

Secondary Objective: The secondary objectives of the study are to assess the efficacy and immunogenicity of long-term epratuzumab treatment in subjects with SLE.

Secondary Outcome(s)

Secondary end point(s): The percent of subjects meeting treatment response criteria at time points other than Week 96 and Week 192, according to the combined index.

Timepoint(s) of evaluation of this end point: Baseline - 192 weeks

Secondary ID(s)

SL0012

Source(s) of Monetary Support

UCB Inc.