E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic Lupus Erythematosus (SLE) |
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E.1.1.1 | Medical condition in easily understood language |
Systemic Lupus Erythematosus (SLE) |
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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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025139 |
E.1.2 | Term | Lupus erythematosus systemic |
E.1.2 | System Organ Class | 100000004859 |
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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 evaluate the safety and tolerability of LY2127399 (120 mg every 4 weeks [Q4W] + SoC or 120 mg every 2 weeks [Q2W] + SoC) in patients with SLE who have completed 52 weeks of treatment in either Study BCDS or Study BCDT. Safety and tolerability assessments for Study BCDX include the following:
- Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
- Laboratory evaluations (including chemistry, immunoglobulins, hematology, B cell counts, and urinalysis)
- Immunogenicity (anti-LY2127399 antibodies) |
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E.2.2 | Secondary objectives of the trial |
The following secondary objectives will examine the effect over time during long-term administration of LY2127399 on the following outcomes:
- Proportion of patients who achieve a response over time as defined by the SLE responder index-5 (SRI-5).
- Proportion of patients who achieve a response as defined by each subcomponent of SRI-5.
- Proportion of patients who achieve a response as defined by the SRI-4, the SRI-6, and the SRI-7.
- Proportion of patients able to decrease dose to 7.5 mg/day or less of prednisone or equivalent, with quiescent disease (BILAG C score or better in all 9 systems) and no flares (BILAG A or B) for at least 3 consecutive months.
- Change in anti-double-stranded deoxyribonucleic acid (anti-dsDNA) level.
- Change in SLE Disease Activity Index-2000 (SLEDAI-2K) score.
- Proportion of patients with new severe SLE flares (modified SELENA-SLEDAI Flare Index [SFI]).
- Patient-reported outcomes (PROs) as measured by Lupus Quality of Life (Lupus QoL) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients are eligible to be included in the study only if they meet all of the following criteria:
- Have completed 52 weeks of treatment in Study BCDS or Study BCDT.
- For female patients of childbearing potential, must test negative for pregnancy at the time of enrollment and agree to use a reliable method of birth control or remain abstinent while on study drug and for at least 8 weeks following the last dose of study drug or- For female patients of non-childbearing potential, defined as:
• Women who have had surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation)
• Women ≥60 years of age
• Women ≥40 and <60 years of age who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential (FSH ≥40 mIU/mL).
- Have given written informed consent approved by Lilly or its designee and the Investigational Review Board/Ethical Review Board (IRB/ERB) governing the site. |
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E.4 | Principal exclusion criteria |
Patients will be excluded from the study if they meet any of the following criteria:
- Presence of significant uncontrolled cerebrocardiovascular (for example: myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic or neuropsychiatric disorders, infectious events or abnormal laboratory
values (based on results obtained from the previous study visit in Study BCDS or BCDT, and/or recent local laboratory data, if available) that in the opinion of the Investigator pose an unacceptable risk to the patient if study drug would be administered. NOTE: Patients with evidence of active or latent tuberculosis (TB) infection at Visit 1 are excluded.
- Have any other condition that renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol, in the opinion of the Investigator.
- Are unwilling or unable to comply with study procedures.
- Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Are Lilly employees or representatives of a third party organization (TPO) involved in the study who require exclusion of their employees. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of Study BCDX is to evaluate the safety and tolerability of LY2127399 in patients with SLE who have completed 52 weeks of treatment in either Study BCDS or Study BCDT. Safety and tolerability assessments will include frequency of TEAEs and SAEs and laboratory evaluations. |
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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) |
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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 | 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 7 |
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 |
Bulgaria |
Canada |
France |
Italy |
Japan |
Austria |
Croatia |
New Zealand |
Romania |
Argentina |
Australia |
Belarus |
Brazil |
Chile |
Colombia |
Ecuador |
Egypt |
Germany |
Guatemala |
Hungary |
India |
Korea, Democratic People's Republic of |
Latvia |
Malaysia |
Spain |
Thailand |
Israel |
Macedonia, the former Yugoslav Republic of |
Mexico |
Peru |
Philippines |
Poland |
Russian Federation |
Serbia |
Singapore |
South Africa |
Taiwan |
Tunisia |
Turkey |
Ukraine |
United Kingdom |
United States |
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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 | 5 |
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 | 5 |
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 |