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

Last updated: December 30, 2021
Sponsor: Janssen-Cilag Ltd.
Overall Status: Completed

Phase

3

Condition

Warts

Rosacea

Scalp Disorders

Treatment

N/A

Clinical Study ID

NCT03998683
CR108611
CNTO1959PSO3013
2018-003206-58
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Should have all the following: A confirmed diagnosis of moderate-to-severepalmoplantar-non-pustular psoriasis with palm and/or sole involvement and at least oneplaque at a body site other than the palms and soles for at least 6 months, to confirma diagnosis of chronic psoriasis; psoriatic area and severity index (PASI) scoregreater than or equal to (>=) 3 and less than (<) 10 at screening and at baseline;Palmoplantar Investigator Global Assessment (ppIGA) score >=3 at screening and atbaseline
  • Should be eligible to receive biological treatments; only participants who are naiveto biological treatments can be included
  • A woman of childbearing potential must have a negative urine pregnancy test atscreening and at Week 0
  • Agree not to receive a live virus or live bacterial vaccination during the study, orwithin 12 weeks after the last administration of study intervention
  • Agree to avoid prolonged sun exposure and agree not to use tanning booths or otherultraviolet (UV) light sources from the first administration of study interventionthrough 12 weeks after the final dose of study intervention (Week 56)

Exclusion

Exclusion Criteria:

  • Currently has palmoplantar pustulosis, pustular psoriasis, or any other forms otherthan plaque-type psoriasis (e.g, erythrodermic, guttate), or hyperkeratotic eczema
  • Has current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation ofpsoriasis 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, orineligible to treatment with biological agents
  • Is infected with human immunodeficiency virus (HIV, positive serology for HIVantibody)

Study Design

Total Participants: 117
Study Start date:
September 03, 2019
Estimated Completion Date:
November 30, 2021

Study 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.

Connect with a study center

  • CHU Bordeaux - Hopital St Andre

    Bordeaux, 33000
    France

    Site Not Available

  • Hôpital Edouard Herriot

    Lyon Cedex 03, 69437
    France

    Site Not Available

  • CHU de Nice Hopital de l Archet

    Nice, 06200
    France

    Site Not Available

  • Hopital Charles Nicolle

    Rouen, 76031
    France

    Site Not Available

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455
    Germany

    Site Not Available

  • University Hospital Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt

    Frankfurt am Main, 60590
    Germany

    Site Not Available

  • MensingDerma research GmbH

    Hamburg, 22391
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig Holstein Campus Lübeck

    Lubeck, 23538
    Germany

    Site Not Available

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • Universitaetsklinikum Muenster

    Muenster, 48149
    Germany

    Site Not Available

  • Centrovital

    Witten, 58453
    Germany

    Site Not Available

  • AOU di Cagliari

    Cagliari, 09124
    Italy

    Site Not Available

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

    Catania, 95123
    Italy

    Site Not Available

  • Ospedale Santa Chiara AO Universitaria Pisana

    Pisa, 56126
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916
    Spain

    Site Not Available

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031
    Spain

    Site Not Available

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hosp. de Manises

    Valencia, 46940
    Spain

    Site Not Available

  • Rame Medical Ltd

    Cornwall, PL11 2TB
    United Kingdom

    Site Not Available

  • Russell's Hall Hospital

    Dudley, DY1 2HQ
    United Kingdom

    Site Not Available

  • Chapel Allerton Hospital

    Leeds, LS7 4SA
    United Kingdom

    Site Not Available

  • Barts Health NHS Trust

    London, E11 1NR
    United Kingdom

    Site Not Available

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • Salford Royal NHS Foundation Trust

    Salford, M6 8HD
    United Kingdom

    Site Not Available

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