Palmo-Plantar Pustular Psoriasis Clinical Trial
Official title:
Safety and Efficacy of Ustekinumab in the Treatment of 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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment