E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic Lupus Erythematosus |
|
E.1.1.1 | Medical condition in easily understood language |
Systemic Lupus Erythematosus is a disease in whcih the body's own immune system attacks its own cells and tissues, leading to inflammation and damage. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
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 |
|
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 |
To evaluate the long-term safety and tolerability of intravenous (IV) MEDI-546 in adult
subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE). |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the immunogenicity (IM) of MEDI-546.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Must provide written informed consent
Must have qualified for and completed study CD-IA-MEDI-546-1013
Must be willing to use 2 methods of effective contraception
Must have adequate venous access
Must be willing to forego other forms of experimental treatment
Must be able to complete the study period.
Has adequate reading and writing abilities to comprehend and complete the informed consent,
and all protocol-related subject assessments. |
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E.4 | Principal exclusion criteria |
-Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
-Major surgery within 8 weeks before signing ICF
-Concomitant medications within the last 12 weeks: Azathioprine greater
than 200mg/day, Mycophenolate mofetil/mycophenolic acid greater than 2.0g/day, oral, sc, or intramuscular methotrexate greater than 25mg/week
- Receipt of a live or attenuated vaccine within 4 weeks of signing the ICF
-Receipt of Bacillus of Calmette and Guerin (BCG) vaccine within 1 year of ICF |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The safety and tolerability of MEDI-546 will be assessed primarily by
summarizing treatment-emergent adverse events and treatment emergent
serious adverse events |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Although no formal interim analyses of the extension period data are planned, analyses of the
accumulating data during the extension period may be performed to assess the ongoing safety
and risk/benefit of the study treatment and to assist with Phase 3 planning. The final analysis
of extension period data will take place after the last on-study subject completes the
extension period follow-up visit or discontinues from the study. |
|
E.5.2 | Secondary end point(s) |
The secondary objective of this study is to evaluate the IM of MEDI-546. Immunogenicity
results will be analyzed by summarizing the number and percentage of subjects who develop
detectable ADAs. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Although no formal interim analyses of the extension period data are planned, analyses of the
accumulating data during the extension period may be performed to assess the ongoing safety
and risk/benefit of the study treatment and to assist with Phase 3 planning. The final analysis
of extension period data will take place after the last on-study subject completes the
extension period follow-up visit or discontinues from the study. |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
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.8.3 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
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 |
Brazil |
Bulgaria |
Colombia |
Czech Republic |
Hungary |
Korea, Republic of |
Mexico |
Peru |
Poland |
Romania |
Taiwan |
Ukraine |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
The end of the study ("study completion") is defined as the date of the
last protocol-specified visit/assessment (including telephone contact) for the last subject in
the study. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |