Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies

Exclusion Criteria

• •Have predominantly pustular, erythrodermic, and/or guttate forms of psoriasis.
• •History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) at Screening. Subjects with a positive or indeterminate PPD or QFT test may participate in the study if a full tuberculosis work up (according to local practice/guidelines) is completed within 12 weeks prior to randomization and establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated at least for 4 weeks prior to randomization and the course of prophylaxis is planned to be completed.
• •Subjects with a history of HIV, or history of positive HCV or HBV
• •Use of any of the following therapies within 4 weeks prior to Baseline (Visit 2): systemic non-biologic psoriasis therapies (including, but not limited to): psoralens and ultraviolet A (PUVA) therapy, cyclosporine, methotrexate, azathioprine, corticosteroids, apremilast, tofacitinib, oral retinoids, mycophenolate mofetil, sirolimus; 1, 25 dihydroxyvitamin D analogs; or phototherapy (including UVB or self-treatment with tanning beds or therapeutic sunbathing) or topical psoriasis therapy with psoralens.
• •Use of topical corticosteroid preparations, topical calcineurin inhibitors, or other topical preparations with immunomodulatory properties within 2 weeks prior to Baseline (Visit 2).
• •Use of any investigational drug or any systemic drug for psoriasis within four weeks prior to Baseline (Visit 2).
• •Serious concomitant illness that could require the use of systemic corticosteroids or otherwise interfere with the patient's participation in the trial.
• •Clinically important deviation as judged by the investigator (such WBC\< 3) from normal limits in physical examination, vital sign measurements, clinical laboratory tests results, not associated with a chronic, well-controlled medical condition.
• •Any active live-vaccines 3 months prior to baseline and throughout the study.
• •Have a current or history of lymphoproliferative disease within 5 years prior to Baseline (Visit 2); or have current or history of any malignant disease within 5 years prior to Baseline (Visit 2).
• •History of suicide attempt, or are clinically judged by investigator to be at risk of suicide.
• •History of Crohn's disease.
• •Had a serious infection, been hospitalized, or received IV antibiotics for an infection, within 12 weeks prior to Baseline (Visit 2).
• •Known immunodeficiency, or history of infection typical of an immunocompromised host.
• •At screening, have a neutrophil count \<1500 cells/uL.
• •At screening, have a lymphocyte count \<800 cells/uL.
• •At screening, have a platelet count \<100,000 cells/uL.
• •At screening, have a total white blood count (WBC) \< 3000 cells/uL.
• •At screening, have a hemoglobin \<8.5 g/dL.
• •Have donated \>450 mL of blood within 4 weeks prior to screening (Visit 1), or intend to donate blood during the course of the study.
• •Women who are lactating or breastfeeding.
• •Any other condition that precludes the patient from following and completing the protocol, in the opinion of the investigator.