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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Safety and Efficacy of Ustekinumab in the Treatment of Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis

Brief Summary: 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)

Detailed Summary:

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.


Sponsor: Innovaderm Research Inc.

Current Primary Outcome:

  • Proportion of patients with PPPP who reach PPPASI-50 at Week 16 for patients randomized to ustekinumab as compared to patients randomized to placebo [ Time Frame: 16 week ]
  • Proportion of patients with PPP who reach PPPASI-50 at Week 16 for patients randomized to ustekinumab as compared to patients randomized to placebo. [ Time Frame: 16 Weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluation of safety of ustekinumab as compared to placebo by reporting the incidence rates of adverse events and serious adverse events in patient with PPPP [ Time Frame: 28 Weeks ]
  • Proportion of patients with PPPP who reach PPPASI-75 at Week 16 for patients randomized to ustekinumab as compared to patients randomized to placebo [ Time Frame: 16 Weeks ]
  • Changes from baseline in PPPASI at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo [ Time Frame: baseline to 16 Weeks ]
  • Changes from baseline in the PPPGA at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo [ Time Frame: baseline to 16 Weeks ]
  • Changes from baseline in PPSA at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo [ Time Frame: baseline to 16 Weeks ]
  • Changes from baseline in the DLQI at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo [ Time Frame: baseline to 16 Weeks ]
  • Changes from baseline in WPAI:PSO at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo [ Time Frame: baseline to 16 weeks ]
  • Changes from baseline in PPQoLI at Week 16 for patients with PPPP randomized to ustekinumab as compared to patients randomized to placebo [ Time Frame: baseline to 16 Weeks ]
  • Changes from baseline in PPPP at Week 28 for patients randomized to ustekinumab as measured with the PPPASI, PPPGA, PPSA, DLQI, WPAI:PSO and PPQoLI. [ Time Frame: baseline to 28 Weeks ]


Original Secondary Outcome: Same as current

Information By: Innovaderm Research Inc.

Dates:
Date Received: March 18, 2010
Date Started: March 2010
Date Completion:
Last Updated: June 10, 2013
Last Verified: June 2013