Study to Evaluate the Safety and Efficacy of Placulumab (CEP-37247) Administered by the Transforaminal Epidural Route for the Treatment of Patients With Lumbosacral Radicular Pain Associated With Disk Herniation

Exclusion Criteria

• •The patient:
• •has a documented history of an allergic reaction (hives, rash, etc.) or a clinically significant intolerance to study drug or ingredients.
• •has a body mass index (BMI) greater than 40 kg/m2.
• •the patient has an established history of a major psychiatric disorder, not controlled with medication or appears to have anxiety that would interfere with clinical pain scores or participation in the trial.
• •has clinically significant abnormalities in clinical chemistry, hematology or urinalysis, including serum glutamic-oxaloacetic transaminase/aspartate aminotransferase (AST) or serum glutamic-pyruvic transaminase/alanine aminotransferase (ALT) greater than or equal to 3 times the upper limit of the reference range or an estimated glomerular filtration rate (eGFR) less than or equal to 30 mL/min/1.73 m2 (Modification of Diet in Renal Disease \[MDRD\] study formula) at screening.
• •has received an intra-epidural steroid injection for the treatment of the current episode of sciatica during the last 3 months prior to screening.
• •has significant pain unrelated to the disk herniation that would significantly compromise assessment of the radicular back and leg pain related to the disk herniation.
• •has radiologic evidence of disk herniation at more than 1 spinal level, and clinical evidence of lumbosacral radicular pain at more than 1 spinal nerve corresponding to the levels of the multiple disk herniations.
• •has received any investigational drug within 30 days prior to screening, or is scheduled to receive an investigational drug other than blinded study drug during the course of this study.
• •has had lumbar or sacral back surgery related to the specific disk that is the cause of the radicular pain upon presentation to the study, or currently plans to undergo spine surgical intervention while in the study.
• •has received epidural corticosteroid injections in the back within 3 months of screening.
• •is involved in an ongoing worker's compensation claim, disability claim, or litigation related to any pain problem.
• •has any active infection that is not self-limiting and not resolved prior to study drug administration.
• •has a history of malignancy or evidence of malignancy or lymphoproliferative or neoplastic disease with the exception of successfully treated basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia within 5 years of the screening visit.
• •has a history of systemic fungal infection.
• •has a history of opportunistic infection within 3 months prior to screening.
• •has a history of known or suspected chronic infection, tuberculosis, hepatitis B virus (HBV), hepatitis C virus (HCV), or Human Immunodeficiency Virus (HIV). The investigator will review all medical history (including medication history), and patients found to be HIV positive based on medical review are to be excluded from the study.
• •has a history of any demyelinating disease, including multiple sclerosis and optic neuritis.
• •has used anti-tumor necrosis factor (TNF) receptor medication (anakinra \[KINERET®, Biovitrum\]) or anti-TNF medication (etanercept \[ENBREL®, Amgen Inc.\], infliximab \[REMICADE®, Centocor Ortho Biotech Inc.\], or adalimumab \[HUMIRA®, Abbott Laboratories\], or any experimental TNF inhibitor) within the past year.
• •has a planned joint replacement surgery or a history of infected joint prosthesis or has received antibiotics for a suspected infection of a joint prosthesis if that prosthesis has not been removed or replaced.
• •has been given live vaccines within 14 days of study drug administration.
• •has severe spinal stenosis or spondylolisthesis (grade 2 or higher).
• •has coagulopathy.
• •is a pregnant or lactating woman (any women becoming pregnant during the study will be withdrawn from the study).
• •has a history of diabetic neuropathy or peripheral neuropathy in the lower extremities.
• •has a history of any condition (not otherwise specified) known to be amenable to TNF inhibitors (e.g., Crohn's disease).
• •has a known allergy or idiosyncratic (atopic) reaction to contrast agent, local anesthetic, study drug, any ingredient listed as being present in a study formulation, or any other pain management compound likely to be prescribed in the study, including their metabolites (if applicable) or any ingredient listed as being present in their formulations.
• •has any clinically significant uncontrolled medical condition (treated or untreated).