NCT03998683

A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis

A Phase 3b, Multicenter, Interventional, Randomized, Placebo-controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Janssen-Cilag Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of guselkumab for the treatment of palmoplantar psoriasis.

Detailed description

Chronic plaque psoriasis is the most common form of psoriatic skin disease; however, there is growing evidence that other variants including scalp, nail, inverse, and palmoplantar psoriasis are prevalent, undertreated, and are correlated with an increased risk of psoriatic arthritis that may result in significant morbidity with functional impairment and greater impairment in quality of life. Therefore, the main aim of the study is to provide robust efficacy and safety data on guselkumab treatment for palmoplantar non-pustular psoriasis. The study comprises of a Screening Phase (4 Weeks \[Week -4 to 0\]), a Treatment Phase (up to Week 48) and a post-treatment follow-up phase (up to Week 56). Key efficacy assessments include physician assessments and patient-reported outcomes questionnaires. Safety evaluations will include 12-lead electrocardiogram at baseline, pregnancy testing and monitoring of vital signs at all visits and recording of adverse events throughout the study. Also, participants will be evaluated for signs and symptoms of active tuberculosis at all visits including follow-up visit. Biomarker assessments will include the evaluation of relevant markers in serum for all participants. The study will have an overall duration of 56 weeks.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Guselkumab 100 mg	Guselkumab 100 mg will be administered as SC injection.
DRUG	Placebo	Placebo will be administered as SC injection.

Timeline

• Start date: 2019-09-03
• Primary completion: 2021-03-02
• Completion: 2021-11-30
• First posted: 2019-06-26
• Last updated: 2022-01-03

Locations

26 sites across 5 countries: France, Germany, Italy, Spain, United Kingdom