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Therapeutic Areas: Immunology | Musculoskeletal | Rheumatology | Family Medicine
Disease Category: Lupus
Location: United States, NJ
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE)
Patient Inclusion Criteria:
- Are males or females =18 years of age.
- Have a clinical diagnosis of SLE defined as meeting 4 of the 11 American
College of Rheumatology (ACR) criteria (Protocol BCDS American College
of Rheumatology (ACR) Criteria for Lupus, Attachment 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.
- 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.)
- 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 during the study or for at least 8 weeks following the last
dose of study drug, whichever is longer, 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, or
- 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.
Patient Exclusion Criteria:
- 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.
- 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.
- Have received oral corticosteroids at daily doses of >40 mg of prednisone or
its equivalent (including IV equivalent) within 30 days prior to baseline.
- Have adjusted their dose of oral antimalarial drugs, such as chloroquine,
hydroxychloroquine, or quinacrine, within 30 days prior to baseline.
- Have initiated treatment of immunosuppressant drugs, such as azathioprine,
leflunomide, MTX, mycofenolate mofetil, mycofenolate sodium, cyclophosphamide, or cyclosporine, within 90 days prior to baseline.
- Have adjusted their dose of immunosuppressant drugs, such as azathioprine,
leflunomide, MTX, mycofenolate mofetil, mycofenolate sodium, cyclophosphamide, or cyclosporine, within 30 days prior to baseline.
- Have received intravenous immunoglobulin (IVIg) within 180 days prior to
- Have previously received rituximab or any other B cell targeted therapies.
- Have received any biologic disease-modifying antirheumatic drug (DMARD)
including etanercept, anakinra, infliximab, adalimumab, golimumab, certolizumab, tocilizumab, and abatacept within 90 days; or any other biologic therapy within 5 half-lives prior to baseline.
- Have received plasmapheresis within 90 days prior to baseline.
- Have received a live vaccine within 90 days prior to baseline or intend to
receive a live vaccine during the course of the study.
- Have a history of severe reaction to any biologic therapy that, in the opinion
of the investigator, puts the patient at serious risk.
- Have an active or recent infection (including symptomatic herpes zoster or
herpes simplex) within 30 days of screening. H9B-MC-BCDS Clinical Protocol Page 33 LY2127399
- Have had a serious infection (for example, pneumonia, cellulitis) within
90 days prior to baseline or a serious bone or joint infection within 180 days
prior to baseline or, in the opinion of the investigator, are immunocompromised to an extent such that participation in the study would pose an unacceptable risk to the patient.
- Have evidence of or test positive for active hepatitis B (positive for hepatitis B
surface antigen [HBsAg+]) OR are positive for hepatitis B core antibody and
negative for hepatitis B surface antibody (HBcAb+, HBsAb-) at screening.
- Have hepatitis C virus (HCV; positive for anti-hepatitis C antibody, confirmed
by Hepatitis C recombinant immunoblot assay [RIBA]).
- Are positive for human immunodeficiency virus (HIV; positive for human
- Have evidence of active or latent tuberculosis (TB) as documented by a
positive purified protein derivative (PPD) test (=5 mm induration between approximately 2 and 3 days after application, regardless of vaccination history), medical history, and chest x-ray at screening. In countries where the QuantiFERON®-TB Gold test is available and certified, it may be used instead
of the PPD test (patients with positive tests are excluded). If the QuantiFERON®-TB Gold test is indeterminate, a retest is allowed. If the retest is also indeterminate, the patient will be excluded from the study. Exceptions include patients with a history of active or latent TB who have documented evidence of appropriate treatment.
- Have experienced a thrombotic event within 180 days prior to baseline or
have adjusted their dose of an anticoagulant drug within 30 days prior to
- Presence of electrocardiogram (ECG) abnormalities that, in the opinion of the
investigator, are considered clinically significant and would pose an unacceptable risk to the patient if participating in the study.
- Have significant hematological abnormalities, including hemoglobin <8 g/dL,
total platelet count <25,000 cells/µL, neutrophil count <1500 cells/µL, or
lymphocyte count <300 cells/µL.
- Presence of significant uncontrolled cerebro-cardiovascular (for example,
myocardial infarction, unstable angina, unstable arterial hypertension, severe
heart failure, or cerebrovascular accident [CVA]), respiratory, hepatic, renal,
gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or
abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the patient if study drug would be administered.
H9B-MC-BCDS Clinical Protocol Page 34 LY2127399
- Have had any malignancy within the past 5 years, except for cervical
carcinoma in situ that has been resected with no evidence of recurrence or
metastatic disease, or basal cell or squamous epithelial skin cancers that were
completely resected and have no evidence of recurrence for at least 3 years
prior to baseline.
- Have had a major surgery within 60 days prior to baseline or will require such
during the study that, in the opinion of the investigator in consultation with
Lilly or its designee, would pose an unacceptable risk to the patient.
- 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.
- Have previously received LY2127399 in this or any other study.
- Are women who are lactating or breast-feeding.
- Have donated blood of more than 500 mL within the past 30 days or intend to
donate blood during the course of the study.
- 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 third party organizations involved in
the study who require exclusion of their employees.
- Are currently enrolled in, or discontinued within the last 30 days or within
5 half-lives (whichever is longer) from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Mary Jo Sites
Physicians Research Center, LLC
601 Route 37 West, Suite 104
Toms River, NJ 08755
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