NCT02641730

An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Palmoplantar Pustulosis

Interventions

Type	Name	Description
DRUG	Guselkumab	Participants will receive two or one syringe of guselkumab 100 mg subcutaneously at Week 0, 4, 12 and every 8 weeks thereafter through Week 60 in group 1 or 2. Group 3a or 3b participants will receive two or one syringe of guselkumab 100 mg at Week 16, 20 and every 8 weeks thereafter through Week 60.
DRUG	Placebo	Participants in group 1 will receive placebo at Week 16. Participants in group 2 will receive placebo at Week 0, 4, 12, 16, 20 and every 8 weeks thereafter through Week 60. Participants in group 3 will receive placebo at Week 0, 4, 12, then at Week 16, 20 and every 8 weeks thereafter through Week 60 for group 3b.

Timeline

• Start date: 2015-12-15
• Primary completion: 2017-03-28
• Completion: 2018-07-17
• First posted: 2015-12-29
• Last updated: 2025-02-04
• Results posted: 2019-02-21

Locations

32 sites across 1 country: Japan