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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)
Full description
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.
Enrollment
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Inclusion criteria
Have had for at least 6 months either:
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:
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:
Female patients of childbearing potential have had a negative serum pregnancy test at the screening visit
Exclusion criteria
Primary purpose
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Interventional model
Masking
33 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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