Clinical trial NCT03998683: A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-26
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Participants who Achieve Palmoplantar Pustulosis Psoriasis Area and Severity Index 75 (ppPASI75) Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Change from Baseline in Body Surface Area (BSA) Score at Weeks 16, 24 and 48
timeFrame: Baseline and Weeks 16, 24 and 48
measure: Change from Baseline in absolute PASI Score at Weeks 16, 24 and 48
timeFrame: Baseline, Weeks 16, 24 and 48
measure: Percentage of Participants Achieving PASI 75 Score at Weeks 16, 24 and 48
timeFrame: Weeks 16, 24 and 48
measure: Percentage of Participants Achieving PASI 90 Score at Weeks 16, 24 and 48
timeFrame: Weeks 16, 24 and 48
measure: Percentage of Participants Achieving PASI 100 at Weeks 16, 24 and 48
timeFrame: Weeks 16, 24 and 48
measure: Change from Baseline in Palmoplantar Quality-of-Life Instrument (ppQLI) Score at Weeks 16, 24 and 48
timeFrame: Baseline and Weeks 16, 24 and 48
measure: Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16, 24 and 48
timeFrame: Baseline and Weeks 16, 24 and 48
measure: Change from Baseline in European Quality of Life, 5-Dimension, 5-Level (EQ-5D-5L) Score at Weeks 16, 24 and 48
timeFrame: Baseline and Weeks 16, 24 and 48
measure: Change from Baseline in Palmoplantar Investigator Global Assessment (ppIGA) Score at Weeks 16, 24 and 48
timeFrame: Baseline and Weeks 16, 24 and 48
measure: Change from Baseline in Fingernail-Physician Global Assessment (f-PGA) Score at Weeks 16, 24 and 48
timeFrame: Baseline and Weeks 16, 24 and 48
measure: Percentage of Participants who Achieve ppPASI75 response at Weeks 24 and 48
timeFrame: Weeks 24 and 48
measure: Percentage of Participants who Achieve ppPASI90 response at Weeks 24 and 48
timeFrame: Weeks 24 and 48
measure: Percentage of Participants who Achieve ppPASI100 response at Weeks 24 and 48
timeFrame: Weeks 24 and 48
measure: Change from Baseline in Work Productivity and Activity Impairment: Psoriasis (WPAI: PSO) Score at Weeks 16, 24 and 48
timeFrame: Baseline and Weeks 16, 24 and 48
measure: Change from Baseline in Numerical Rating Scale: Pain (NRS:P) Score at Weeks 16, 24 and 48
timeFrame: Baseline and Weeks 16, 24 and 48
measure: Number of Participants with Adverse Event (AEs) as a Measure of Safety and Tolerability
timeFrame: Up to 56 weeks
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux - Hopital St Andre
city: Lyon Cedex 03
country: France
facility: Hôpital Edouard Herriot
city: Nice
country: France
facility: CHU de Nice Hopital de l Archet
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Dresden
country: Germany
facility: University Hospital Dresden
city: Frankfurt am Main
country: Germany
facility: Universitatsklinikum Frankfurt
city: Hamburg
country: Germany
facility: MensingDerma research GmbH
city: Lubeck
country: Germany
facility: Universitätsklinikum Schleswig Holstein Campus Lübeck
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Witten
country: Germany
facility: Centrovital
city: Cagliari
country: Italy
facility: AOU di Cagliari
city: Catania
country: Italy
facility: P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'
city: Pisa
country: Italy
facility: Ospedale Santa Chiara AO Universitaria Pisana
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Madrid
country: Spain
facility: Hosp. Univ. Infanta Leonor
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Valencia
country: Spain
facility: Hosp. de Manises
city: Dudley
country: United Kingdom
facility: Russell's Hall Hospital
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: