Safety and Efficacy of Ustekinumab in Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis
Safety and Efficacy of Ustekinumab in Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis
This study will provide data on sasety and efficacy of Ustekinumab in patients suffering from
 Palmo-Plantar Pustular Psoriasis (PPPP) or Palmo-Plantar Pustulosis(PPP)
Twenty patients with active Palmo-Plantar Pustular Psoriasis (cohort A) and twenty patients
 with active Palmo-Plantar Pustulosis (cohort B) will be included in this placebo-controlled
 double-blind study.Patients in each cohort will be randomized (1:1) to receive either
 ustekinumab S/C (Sub-Cutaneous) (45 mg for patients weighting 100 kg or less, and 90 mg for
 patients weighting more than 100 kg) or placebo.

 Patients randomized to ustekinumab (10 with PPPP and 10 with PPP) will receive ustekinumab at
 Day 0, Weeks 4 and 16 and placebo at Week 20 whereas patients randomized to placebo (10 with
 PPPP and 10 with PPP) will receive placebo at Weeks 0 and 4 and ustekinumab at Weeks 16 and
 20.

 Patients will be seen at screening, Day 0, Weeks 4, 8, 16, 20, 24 and 28. The PPPASI
 (Palmo-Plantar Pustular Area and Severity Index), PPPGA (Palmo-Plantar Physician Global
 Assessment), PPSA (Palmo-Plantar Surface Area) will be used to evaluate severity and DLQI
 (Dermatology Life Quality Index), WPAI:PSO (Work Productivity and Activity Impairement
 Questionnaire:Psoriasis) and PPQoLI (Palmo-Plantar Quality of Life Index)will be used to
 evaluate quality of life. Safety will be assessed by physical examinations, evaluation of
 adverse events and laboratory analyses.

 High quality digital medical photographs of palms and soles will be taken at Day 0, Weeks 4,
 16 and 28. In addition, one optional skin biopsy from a palm or a sole will be performed at
 Day 0 and Week 16 and pus will be collected from pustules on palms and/or soles at Day 0 and
 Week 16. Finally, blood will be collected at Day 0 for genetic analysis from every patient
 who consents to DNA blood sampling.
Inclusion Criteria:

 -  Have had for at least 6 months either:

 -  Palmo-plantar pustular psoriasis defined as active palmo-plantar disease
 morphology suggestive of psoriasis with at least one plaque of typical psoriasis
 outside the palms and soles or a history of typical plaque psoriasis outside the
 palms and soles (cohort A) OR

 -  Palmo-plantar pustulosis defined as active palmo-plantar morphology suggestive of
 palmo-plantar pustulosis without lesions of psoriasis outside palms and soles and
 without a history of psoriasis (cohort B).

 -  PPPASI score of at least 8 on hands and/or feet and a PPPGA score of 3 (moderate) or 4
 (severe) at Day 0

 -  Stable palmo-plantar pustular psoriasis or palmo-plantar pustulosis for the past 4
 weeks

 -  Men or women 18 years of age or older at time of consent

 -  Must be candidate for phototherapy and systemic therapy

 -  Unless surgically sterile (or at least 1 year post-menopausal for women), or
 abstinent, patient (male or female) is willing to use an effective method of
 contraception for at least 30 days before Day 0 and until at least 12 months after the
 last drug administration. Effective method of contraception are:

 -  Condom with spermicide, sponge with spermicide, foams with spermicide, jellies
 with spermicide, diaphragm with spermicide

 -  Intra uterine device (IUD)

 -  Contraceptives (oral or parenteral)

 -  Nuvaring

 -  Vasectomy or vasectomised partner

 -  Surgically sterile or post-menopausal partner

 -  Same-sex partner

 -  Capable of giving informed consent and the consent must be obtained prior to any study
 related procedures

 -  Are considered eligible according to the following TB (Tuberculosis) screening
 criteria:

 -  Have no history of latent or active TB prior to screening Patients with latent TB
 discovered at screening are not eligible for this study, even if they receive
 isoniazide or rifampin prophylaxis.

 -  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

 Exclusion Criteria:

 -  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