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

Psoriasis Clinical Trial

— G-PLUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998683
• Other study ID #: CR108611
• Secondary ID: 2018-003206-58CN
• Status: Completed
• Phase: Phase 3
• Start date: September 3, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: December 2021
• Source: Janssen-Cilag Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: November 30, 2021
• Est. primary completion date: March 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Should have all the following: A confirmed diagnosis of moderate-to-severe palmoplantar-non-pustular psoriasis with palm and/or sole involvement and at least one plaque at a body site other than the palms and soles for at least 6 months, to confirm a diagnosis of chronic psoriasis; psoriatic area and severity index (PASI) score greater than or equal to (>=) 3 and less than (<) 10 at screening and at baseline; Palmoplantar Investigator Global Assessment (ppIGA) score >=3 at screening and at baseline

• Should be eligible to receive biological treatments; only participants who are naive to biological treatments can be included

• A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0

• Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention

• Agree to avoid prolonged sun exposure and agree not to use tanning booths or other ultraviolet (UV) light sources from the first administration of study intervention through 12 weeks after the final dose of study intervention (Week 56)

Exclusion Criteria:

• Currently has palmoplantar pustulosis, pustular psoriasis, or any other forms other than plaque-type psoriasis (e.g, erythrodermic, guttate), or hyperkeratotic eczema

• Has current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)

• Has received prior systemic treatment with biological agents or Janus Kinase (JAK) inhibitors

• Has had prior exposure, known and reported intolerance to guselkumab or excipients, or ineligible to treatment with biological agents

• Is infected with human immunodeficiency virus (HIV, positive serology for HIV antibody)

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Guselkumab 100 mg
Guselkumab 100 mg will be administered as SC injection.
• Placebo
Placebo will be administered as SC injection.

Locations

Country	Name	City	State
France	CHU Bordeaux - Hopital St Andre	Bordeaux
France	Hôpital Edouard Herriot	Lyon Cedex 03
France	CHU de Nice Hopital de l Archet	Nice
France	Hopital Charles Nicolle	Rouen
Germany	Fachklinik Bad Bentheim	Bad Bentheim
Germany	University Hospital Dresden	Dresden
Germany	Universitatsklinikum Frankfurt	Frankfurt am Main
Germany	MensingDerma research GmbH	Hamburg
Germany	Universitätsklinikum Schleswig Holstein Campus Lübeck	Lubeck
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Universitaetsklinikum Muenster	Muenster
Germany	Centrovital	Witten
Italy	AOU di Cagliari	Cagliari
Italy	P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'	Catania
Italy	Ospedale Santa Chiara AO Universitaria Pisana	Pisa
Italy	Istituto Clinico Humanitas	Rozzano
Spain	Hosp. Univ. Germans Trias I Pujol	Badalona
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Univ. Infanta Leonor	Madrid
Spain	Hosp. de Manises	Valencia
Spain	Hosp. Univ. I Politecni La Fe	Valencia
United Kingdom	Russell's Hall Hospital	Dudley
United Kingdom	Chapel Allerton Hospital	Leeds
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	Salford Royal NHS Foundation Trust	Salford

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Ltd.

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who Achieve Palmoplantar Pustulosis Psoriasis Area and Severity Index 75 (ppPASI75) Response at Week 16	Percentage of participants who achieve ppPASI75 response, defined as improvement greater than or equal to (>=) 75 percent (%) in the ppPASI score at Week 16 will be reported. The ppPASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of disease of the palms and/or soles.	Week 16
Secondary	Change from Baseline in Body Surface Area (BSA) Score at Weeks 16, 24 and 48	Change from baseline in BSA score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups by measuring the arithmetic mean of the affected skin surface.	Baseline and Weeks 16, 24 and 48
Secondary	Change from Baseline in absolute PASI Score at Weeks 16, 24 and 48	Change from baseline in absolute PASI score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups.	Baseline, Weeks 16, 24 and 48
Secondary	Percentage of Participants Achieving PASI 75 Score at Weeks 16, 24 and 48	Percentage of participants achieving PASI 75 score (participants who achieve >=75% improvement in PASI score) at Weeks 16, 24 and 48 will be reported in guselkumab versus the placebo group. PASI is a common clinical tool used to measure the severity and extent of psoriasis. The PASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of disease of the palms and/or soles.	Weeks 16, 24 and 48
Secondary	Percentage of Participants Achieving PASI 90 Score at Weeks 16, 24 and 48	Percentage of participants achieving PASI 90 score (participants who achieve >=90 % improvement in PASI score) at Weeks 16, 24 and 48 will be reported in guselkumab versus the placebo group. PASI is a common clinical tool used to measure the severity and extent of psoriasis. The PASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of disease of the palms and/or soles.	Weeks 16, 24 and 48
Secondary	Percentage of Participants Achieving PASI 100 at Weeks 16, 24 and 48	Percenatge of participants who achieving PASI 100 score (participants who achieve >=100 % improvement in PASI score) at Weeks 16, 24 and 48 will be reported in guselkumab versus the placebo group. PASI is a common clinical tool used to measure the severity and extent of psoriasis. The PASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of disease of the palms and/or soles.	Weeks 16, 24 and 48
Secondary	Change from Baseline in Palmoplantar Quality-of-Life Instrument (ppQLI) Score at Weeks 16, 24 and 48	Change from baseline in ppQLI score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. ppQLI assesses relevant dimensions affected by palmoplantar psoriasis (pain/discomfort, functionality, and social/activity limitations) to assess quality of life.	Baseline and Weeks 16, 24 and 48
Secondary	Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16, 24 and 48	Change from baseline in DLQI score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. DLQI a 10-item questionnaire that can be used to assess overall quality-of-life.	Baseline and Weeks 16, 24 and 48
Secondary	Change from Baseline in European Quality of Life, 5-Dimension, 5-Level (EQ-5D-5L) Score at Weeks 16, 24 and 48	Change from baseline in EQ-5D- 5L score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. EQ-5D-5L is a standardized instrument to measure health-related quality of life.	Baseline and Weeks 16, 24 and 48
Secondary	Change from Baseline in Palmoplantar Investigator Global Assessment (ppIGA) Score at Weeks 16, 24 and 48	Change from baseline in ppIGA score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups to assess psoriasis overall lesions.	Baseline and Weeks 16, 24 and 48
Secondary	Change from Baseline in Fingernail-Physician Global Assessment (f-PGA) Score at Weeks 16, 24 and 48	Change from baseline in f-PGA score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups to assess fingernails separately for nail bed and nail matrix for signs of disease.	Baseline and Weeks 16, 24 and 48
Secondary	Percentage of Participants who Achieve ppPASI75 response at Weeks 24 and 48	Percentage of participants who achieve ppPASI75 response, defined as improvement >=75% in the ppPASI score at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. The ppPASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of disease of the palms and/or soles.	Weeks 24 and 48
Secondary	Percentage of Participants who Achieve ppPASI90 response at Weeks 24 and 48	Percentage of participants who achieve ppPASI90 response (participants who achieve >=90 % improvement in the ppPASI score) at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. The ppPASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of the affection of the palms and/or soles.	Weeks 24 and 48
Secondary	Percentage of Participants who Achieve ppPASI100 response at Weeks 24 and 48	Percentage of participants who achieve ppPASI100 response (participants who achieve >=100 % improvement in the ppPASI score) at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. The ppPASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of the affection of the palms and/or soles.	Weeks 24 and 48
Secondary	Change from Baseline in Work Productivity and Activity Impairment: Psoriasis (WPAI: PSO) Score at Weeks 16, 24 and 48	Change from baseline in WPAI: PSO score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. WPAI-PSO is a questionnaire which includes 6 questions to measure work productivity and activity impairment related to skin psoriasis.	Baseline and Weeks 16, 24 and 48
Secondary	Change from Baseline in Numerical Rating Scale: Pain (NRS:P) Score at Weeks 16, 24 and 48	Change from baseline in NRS:P score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. NRS:P is a self-administered scale that assess pain intensity in participants.	Baseline and Weeks 16, 24 and 48
Secondary	Number of Participants with Adverse Event (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to 56 weeks