E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic Lupus Erythematosus
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042945 |
E.1.2 | Term | Systemic lupus erythematosus |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to assess the safety and tolerability of long-term epratuzumab treatment in subjects with SLE. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are to assess the efficacy and immunogenicity of long-term epratuzumab treatment in subjects with SLE. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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. Concomitant participation in studies where no product or
device is administered/used may be allowed if discussed and approved by the medical monitor/UCB.
-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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The percent of subjects meeting treatment response criteria at Week 48 and Week 96 according to a combined response index.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The percent of subjects meeting treatment response criteria at time points other than Week 48 and Week 96, according to the combined index. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 16 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Brazil |
Canada |
Hong Kong |
India |
Israel |
Korea, Republic of |
Mexico |
Russian Federation |
South Africa |
Taiwan |
Ukraine |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study is defined as the date of the last visit of the last subject in the study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |