A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis

Inclusion Criteria: Palmoplantar pustulosis with a severity score of at least 8 on hands and-or feet Age 18 years or older Patient who would benefit from systemic therapy Unless surgically sterile (or at least 1 year post-menopausal for women) patients (heterosexual men and women) must have used a effective method of contraception for at least 30 days before the start of the study drug and until at least 1 month after the last drug administration Informed consent obtained Normal or non clinically significant chest X ray taken within 6 months of screening Negative serum pregnancy test at screening and negative urine pregnancy test at day 0 for women of childbearing potential Negative personal history of tuberculosis Presence of PPP for more than 6 months Subject must be willing to inject themselves subcutaneously. Negative PPD results Exclusion Criteria: Use of topical steroids, topical tar preparations, or other topical anti PPP or anti-psoriatic preparations within the past two weeks Unstable forms of psoriasis (acute guttate psoriasis, psoriatic erythroderma, generalized pustular psoriasis) At the investigator's discretion any significant infection within 30 days of screening or a patient at risk of septicemia Presence of acute forms of tinea pedis and other causes of pustular eruptions of the palms and soles apart from PPP based on clinical evaluation Evidence of any skin condition that would interfere with the evaluation of PPP Use of investigational drugs within the past four weeks Use of systemic anti-PPP or anti-psoriatic drugs such as steroids, retinoids, or methotrexate within the past four weeks Use of parenteral systemic antibiotics within the past four weeks Use of cyclosporine within the past four weeks Use of ultraviolet light therapy (UVB, nbUVB or PUVA) within the past two weeks An unstable or serious medical condition Known sero-positivity for the HIV virus Known hypersensitivity to etanercept or one of its components Receipt of live attenuated vaccines 12 weeks or less before Day 0 and during the course of the study Pregnant or breast feeding female subject Any significant medical condition that might cause this study to be detrimental to the patient At the investigator's discretion current or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol Presence of congestive heart failure Presence of a demyelinating disorder (optic neuritis, multiple sclerosis or other)