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

NCT ID: NCT03998683

Last Updated: 2022-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-03
• Study Completion Date: 2021-11-30

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Guselkumab Group

Participants will receive guselkumab 100 mg SC injections at Weeks 0, 4, 12 and placebo subcutaneous (SC) injection at Week 16 in double-blind phase followed by guselkumab 100 mg SC injections at Weeks 20, 28, 36, and 44 in open-label phase.

Group Type: EXPERIMENTAL

Guselkumab 100 mg

Intervention Type: DRUG

Guselkumab 100 mg will be administered as SC injection.

Placebo

Intervention Type: DRUG

Placebo will be administered as SC injection.

Placebo Group

Participants will receive placebo SC injection at Weeks 0, 4, 12 and guselkumab 100 mg SC injection at Week 16 in double-blind phase followed by guselkumab 100 mg SC injection at Week 20, 28, 36, and 44 in open-label phase.

Group Type: PLACEBO_COMPARATOR

Guselkumab 100 mg

Intervention Type: DRUG

Guselkumab 100 mg will be administered as SC injection.

Placebo

Intervention Type: DRUG

Placebo will be administered as SC injection.

Interventions

Guselkumab 100 mg

Guselkumab 100 mg will be administered as SC injection.

Intervention Type: DRUG

Placebo

Placebo will be administered as SC injection.

Intervention Type: DRUG

Other Intervention Names

CNTO1959

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag Ltd. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Ltd.

Locations

CHU Bordeaux - Hopital St Andre

Bordeaux, , France

Hôpital Edouard Herriot

Lyon, , France

CHU de Nice Hopital de l Archet

Nice, , France

Hopital Charles Nicolle

Rouen, , France

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

Lübeck, , Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Universitaetsklinikum Muenster

Münster, , Germany

Centrovital

Witten, , Germany

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, , Italy

Hosp. Univ. Germans Trias I Pujol

Badalona, , Spain

Hosp. Univ. Infanta Leonor

Madrid, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp. Univ. I Politecni La Fe

Valencia, , Spain

Hosp. de Manises

Valencia, , Spain

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, , United Kingdom

Countries

France; Germany; Italy; Spain; United Kingdom

Other Identifiers

2018-003206-58

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CNTO1959PSO3013

Identifier Type: OTHER

Identifier Source: secondary_id

CR108611

Identifier Type: -

Identifier Source: org_study_id