E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic Lupus Erythematosus (SLE) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042945 |
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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 this study is to demonstrate the efficacy LY2127399 versus placebo, as assessed by the proportion of patients with SLE who achieve a response at 52 weeks (as measured on a composite disease activity index). Please refer to the Protocol for the complete description of the Main objective. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are as follows: - To demonstrate the corticosteroid sparing effects of LY2127399 compared to placebo over 52 weeks - To demonstrate the effect of LY2127399 on serum markers of SLE including anti-double stranded DNA (antidsDNA) compared to placebo over 52 weeks - To demonstrate the efficacy of LY2127399 on disease activity in patients with SLE compared to placebo over 52 weeks - To demonstrate the efficacy of LY2127399 on reducing time to flare in patients with SLE compared to placebo over 52 weeks - To demonstrate the effect of LY2127399 on fatigue in patients with SLE compared to placebo over 52 weeks - To demonstrate the effect of LY2127399 on quality of life in patients with SLE compared to placebo over 52 weeks. Please refer to the Protocol for the complete description of the secondary objective. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Main Inclusion Criteria: [1] Are males or females ≥18 years of age. [2] Have a clinical diagnosis of SLE defined as meeting 4 of the 11 American College of Rheumatology (ACR) criteria. [3] Have a positive ANA (HEp-2 ANA titer ≥1:80) as assessed by a central laboratory at screening. Patients with a negative ANA test result but positive anti-dsDNA test result at screening will have ANA repeated 1 time during the Screening Period. If the repeat ANA is also negative, the patient will be excluded from the study. [4] Have a screening SELENA-SLEDAI score ≥6. (The patient must be actively exhibiting all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.) |
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E.4 | Principal exclusion criteria |
Main Exclusion Criteria: [5] Have active lupus nephritis as assessed by the investigator or urine protein/creatinine ratio of >200 mg/mmol or estimated creatinine clearance <30 mL/min. If urine protein/creatinine ratio or estimated creatinine clearance are inconsistent with the investigator’s clinical assessment of a patient’s renal function, these tests may be repeated 1 time during the Screening Period. If the repeat tests are also outside the stated values, the patient will be excluded from the study. [6] Have active CNS or peripheral neurologic disease including seizure, psychosis, stroke, cerebritis or isolated CNS vasculitis, myelopathy, Guillain-Barre Syndrome, or other severe neurologic involvement requiring treatment within 90 days prior to screening. Fr the complete list of the esclusion criteria, please refer to the protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving an SLE Responder Index response at week 52. |
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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 | Yes |
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 | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Dosing intervals of 120 mg every 2 weeks versus every 4 weeks |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
3 arm study to investigate dosing intervals (2 weeks vs 4 weeks vs placebo) |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
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 | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 74 |
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 | Information not present in EudraCT |
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 |
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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
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End of study (trial) is the date of the last visit or last scheduled procedure shown in the Study Schedule for the last active patient 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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |