Safety and Efficacy of Ustekinumab in Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis

Exclusion Criteria

• •* No signs or symptoms suggestive of active TB upon medical history and/or physical examination.
• •* No recent close contact with a person with active TB or, if there was such contact, have a negative QuantiFERON-TB Gold test (or a negative tuberculin (less than 5mm) skin test when QuantiFERON-TB Gold is not available) and have been referred to a physician specializing in TB to undergo additional evaluation to rule out TB infection.
• •* Within 6 weeks prior to the first administration of study agent, have a negative QuantiFERON-TB Gold test. For patients enrolled at sites that where QuantiFERON-TB Gold test is not available, have a negative tuberculin (less than 5mm) skin test.
• •* A chest radiograph (posterior-anterior as defined by site-specific requirements), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB
• •Female patients of childbearing potential have had a negative serum pregnancy test at the screening visit
• •Have used topical steroids, topical tar preparations or other topical anti-psoriatic preparations within 2 weeks preceding Day 0 except for the following which is allowed- mild to moderate potency topical corticosteroids for the face, groin, axilla, genitalia and scalp as long as they are applied with gloves: hydrocortisone, desonide, hydrocortisone valerate
• •Have presence of erythrodermic or generalized pustular psoriasis
• •Have presence of acute forms of tinea pedis and other causes of pustular eruptions of palms and soles apart from PPPP or PPP based on clinical evaluation or evidence of any skin condition that would interfere with the evaluation of PPPP or PPP
• •Have had, based on investigator's judgment, any significant infection within 30 days preceding Day 0
• •Have used any investigational drugs within 4 weeks of Day 0 or 5 times the half-life of the investigational agent prior to the first administration of study agent, whichever is longer
• •Have used systemic anti-psoriatic drugs such as steroids, retinoids, cyclosporine, or methotrexate within 4 weeks of Day 0
• •Have used any biologic such as alefacept, etanercept, adalimumab or infliximab within 12 weeks or 5 half-lives which ever is longer of Day 0
• •Have received ultraviolet light therapy: UVB (Ultraviolet B), nbUVB (Narrow Band Ultraviolet B), PUVA (Psoralen Ultraviolet A), or tanning bed within 4 weeks of Day 0
• •Have had any severe, progressive or uncontrolled renal, hepatic, endocrine, cardiac, gastrointestinal, pulmonary, neurologic, psychiatric, cerebral, hematologic medical condition
• •Are known to be infected with hepatitis B, hepatitis C virus or Human Immunodeficiency Virus (HIV)
• •Are currently treated for latent tuberculosis
• •Have or have had a serious infection (eg: sepsis, pneumonia or pyelonephritis) or have been hospitalized or received IV (Intravenous) antibiotics for an infection during the 2 months prior to screening
• •Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent)
• •Have received within 3 months (within 1 year for BCG (Bacillus Calmette-Guérin) vaccination) prior to the first injection a live virus or bacterial vaccination. Patients must agree not to receive a live virus or bacterial vaccination during the trial or up to 12 months after the last study agent injection
• •Have a clinically significant laboratory result that, in the opinion of the investigator, prevents ustekinumab administration for safety reasons
• •Are pregnant, nursing or planning pregnancy (both men and women) while enrolled in the study
• •Are known to have had a substance abuse (drug or alcohol) problem within the previous 12 months
• •Have known hypersensitivity to ustekinumab or any of its components