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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 treatment with biological agents for palmoplantar-non-pustular psoriasis - 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03998683
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen-Cilag Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen-Cilag Ltd. Clinical Trial
Principal Investigator Affiliation Janssen-Cilag Ltd.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries France, Germany, Italy, Spain, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Placebo Comparator: 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.

Interventions

Drug: - Guselkumab 100 mg

Guselkumab 100 mg will be administered as SC injection.

Drug: - Placebo

Placebo will be administered as SC injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Bordeaux - Hopital St Andre, Bordeaux, France

Status

Recruiting

Address

CHU Bordeaux - Hopital St Andre

Bordeaux, , 33000

Hôpital Edouard Herriot, Lyon Cedex 03, France

Status

Recruiting

Address

Hôpital Edouard Herriot

Lyon Cedex 03, , 69437

CHU de Nice Hopital de l Archet, Nice, France

Status

Recruiting

Address

CHU de Nice Hopital de l Archet

Nice, , 06200

Hopital Charles Nicolle, Rouen, France

Status

Recruiting

Address

Hopital Charles Nicolle

Rouen, , 76031

Fachklinik Bad Bentheim, Bad Bentheim, Germany

Status

Recruiting

Address

Fachklinik Bad Bentheim

Bad Bentheim, , 48455

University Hospital Dresden, Dresden, Germany

Status

Recruiting

Address

University Hospital Dresden

Dresden, , 01307

Universitatsklinikum Frankfurt, Frankfurt am Main, Germany

Status

Recruiting

Address

Universitatsklinikum Frankfurt

Frankfurt am Main, , 60590

MensingDerma research GmbH, Hamburg, Germany

Status

Recruiting

Address

MensingDerma research GmbH

Hamburg, , 22391

Lubeck, Germany

Status

Recruiting

Address

Universitätsklinikum Schleswig Holstein Campus Lübeck

Lubeck, , 23538

Mainz, Germany

Status

Recruiting

Address

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , 55131

Universitaetsklinikum Muenster, Muenster, Germany

Status

Recruiting

Address

Universitaetsklinikum Muenster

Muenster, , 48149

Centrovital, Witten, Germany

Status

Recruiting

Address

Centrovital

Witten, , 58453

AOU di Cagliari, Cagliari, Italy

Status

Suspended

Address

AOU di Cagliari

Cagliari, , 09124

Catania, Italy

Status

Suspended

Address

P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'

Catania, , 95123

Pisa, Italy

Status

Suspended

Address

Ospedale Santa Chiara AO Universitaria Pisana

Pisa, , 56126

Istituto Clinico Humanitas, Rozzano, Italy

Status

Suspended

Address

Istituto Clinico Humanitas

Rozzano, , 20089

Hosp. Univ. Germans Trias I Pujol, Badalona, Spain

Status

Recruiting

Address

Hosp. Univ. Germans Trias I Pujol

Badalona, , 08916

Hosp. Univ. Infanta Leonor, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. Infanta Leonor

Madrid, , 28031

Hosp. Univ. 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. 12 de Octubre

Madrid, , 28041

Hosp. Univ. I Politecni La Fe, Valencia, Spain

Status

Recruiting

Address

Hosp. Univ. I Politecni La Fe

Valencia, , 46026

Hosp. de Manises, Valencia, Spain

Status

Recruiting

Address

Hosp. de Manises

Valencia, , 46940

Russell's Hall Hospital, Dudley, United Kingdom

Status

Recruiting

Address

Russell's Hall Hospital

Dudley, , DY1 2HQ

Chapel Allerton Hospital, Leeds, United Kingdom

Status

Recruiting

Address

Chapel Allerton Hospital

Leeds, , LS7 4SA

Barts Health NHS Trust, London, United Kingdom

Status

Recruiting

Address

Barts Health NHS Trust

London, , E11 1NR

Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom

Status

Recruiting

Address

Royal Victoria Infirmary

Newcastle upon Tyne, , NE1 4LP

Salford Royal NHS Foundation Trust, Salford, United Kingdom

Status

Recruiting

Address

Salford Royal NHS Foundation Trust

Salford, , M6 8HD

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