Clinical Trial: An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Palmoplantar Pustul

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of guselkumab for the treatment of participants with palmoplantar pustulosis.

Detailed Summary: This is a phase 3, randomized (study drug assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), multicenter (when more than one hospital works on a medical research study) placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) study in participants with palmoplantar pustulosis. The study will consist of 3 phases: screening phase (up to 6 weeks), treatment period (week 0 - week 60) and observational period (up to week 84). Participants will be assigned to 1 of 3 treatment groups (200 milligram [mg] guselkumab, 100 mg guselkumab or placebo group) using a stratified block randomization method in a 1:1:1 ratio at Week 0 and Group III (placebo) participants will be allocated in a 1:1 ratio to 1 of 2 treatment groups at Week 16. Participants will primarily be assessed for change from baseline in Palmo-Plantar Pustular Area and Severity Index (PPPASI) total score at Week 16. Safety will be monitored throughout the study.
Sponsor: Janssen Pharmaceutical K.K.

Current Primary Outcome: Change From Baseline in Palmo-Plantar Area and Severity Index (PPPASI) Total Score at Week 16 [ Time Frame: Up to Week 16 ]

The PPPASI is a system used for assessing and grading the severity and area of palmoplantar pustulosis lesions and their response to therapy. The PPPASI produces a numeric score that can range from 0 to 72. Higher score indicates worsening.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change From Baseline in Palmo-Planter Severity Index (PPSI) Total Score at Week 16 [ Time Frame: Up to Week 16 ]
    The PPSI assesses the severity of pa lmoplantar pustulosis lesions and their response to therapy with a score ranging from 0 to 12. Higher score indicates worsening.
  • Percentage of Participants who achieve a PPPASI50 at Week 16 [ Time Frame: Week 16 ]


Original Secondary Outcome: Same as current

Information By: Janssen Pharmaceutical K.K.

Dates:
Date Received: December 14, 2015
Date Started: December 15, 2015
Date Completion: January 31, 2019
Last Updated: May 16, 2017
Last Verified: May 2017