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A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis (G-PLUS)

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ClinicalTrials.gov Identifier: NCT03998683
Recruitment Status : Not yet recruiting
First Posted : June 26, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Guselkumab 100 mg Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 22, 2019
Estimated Primary Completion Date : September 16, 2021
Estimated Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Guselkumab

Arm Intervention/treatment
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.
Drug: Guselkumab 100 mg
Guselkumab 100 mg will be administered as SC injection.
Other Name: CNTO1959

Drug: Placebo
Placebo will be administered as SC injection.

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.
Drug: Guselkumab 100 mg
Guselkumab 100 mg will be administered as SC injection.
Other Name: CNTO1959

Drug: Placebo
Placebo will be administered as SC injection.




Primary Outcome Measures :
  1. Percentage of Participants who Achieve Palmoplantar Pustulosis Psoriasis Area and Severity Index 75 (ppPASI75) Response at Week 16 [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change from Baseline in Body Surface Area (BSA) Score at Weeks 16, 24 and 48 [ Time Frame: Baseline and 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.

  2. Change from Baseline in absolute PASI Score at Weeks 16, 24 and 48 [ Time Frame: Baseline, 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.

  3. Percentage of Participants Achieving PASI 75 Score at Weeks 16, 24 and 48 [ Time Frame: 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.

  4. Percentage of Participants Achieving PASI 90 Score at Weeks 16, 24 and 48 [ Time Frame: 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.

  5. Percentage of Participants Achieving PASI 100 at Weeks 16, 24 and 48 [ Time Frame: 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.

  6. Change from Baseline in Palmoplantar Quality-of-Life Instrument (ppQLI) Score at Weeks 16, 24 and 48 [ Time Frame: Baseline and 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.

  7. Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16, 24 and 48 [ Time Frame: Baseline and 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.

  8. Change from Baseline in European Quality of Life, 5-Dimension, 5-Level (EQ-5D-5L) Score at Weeks 16, 24 and 48 [ Time Frame: Baseline and 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.

  9. Change from Baseline in Palmoplantar Investigator Global Assessment (ppIGA) Score at Weeks 16, 24 and 48 [ Time Frame: Baseline and 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.

  10. Change from Baseline in Fingernail-Physician Global Assessment (f-PGA) Score at Weeks 16, 24 and 48 [ Time Frame: Baseline and 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.

  11. Percentage of Participants who Achieve ppPASI75 response at Weeks 24 and 48 [ Time Frame: 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.

  12. Percentage of Participants who Achieve ppPASI90 response at Weeks 24 and 48 [ Time Frame: 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.

  13. Percentage of Participants who Achieve ppPASI100 response at Weeks 24 and 48 [ Time Frame: 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.

  14. Change from Baseline in Work Productivity and Activity Impairment: Psoriasis (WPAI: PSO) Score at Weeks 16, 24 and 48 [ Time Frame: Baseline and 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.

  15. Change from Baseline in Numerical Rating Scale: Pain (NRS:P) Score at Weeks 16, 24 and 48 [ Time Frame: Baseline and 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.

  16. Number of Participants with Adverse Event (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 56 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998683


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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France
CHU Bordeaux - Hopital St Andre Not yet recruiting
Bordeaux, France, 33000
Hôpital Edouard Herriot Not yet recruiting
Lyon Cedex 03, France, 69437
CHU de Nice Hopital de l Archet Not yet recruiting
Nice, France, 06200
Hopital Charles Nicolle Not yet recruiting
Rouen, France, 76031
Germany
Fachklinik Bad Bentheim Not yet recruiting
Bad Bentheim, Germany, 48455
University Hospital Dresden Not yet recruiting
Dresden, Germany, 01307
Universitatsklinikum Frankfurt Not yet recruiting
Frankfurt am Main, Germany, 60590
MensingDerma research GmbH Not yet recruiting
Hamburg, Germany, 22391
Universitätsklinikum Schleswig Holstein Campus Lübeck Not yet recruiting
Lubeck, Germany, 23538
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Not yet recruiting
Mainz, Germany, 55131
Universitaetsklinikum Muenster Not yet recruiting
Muenster, Germany, 48149
Centrovital Not yet recruiting
Witten, Germany, 58453
Italy
AOU di Cagliari Not yet recruiting
Cagliari, Italy, 09124
P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele' Not yet recruiting
Catania, Italy, 95123
Ospedale Santa Chiara AO Universitaria Pisana Not yet recruiting
Pisa, Italy, 56126
Istituto Clinico Humanitas Not yet recruiting
Rozzano, Italy, 20089
Spain
Hosp. Univ. Germans Trias I Pujol Not yet recruiting
Badalona, Spain, 08916
Hosp. Univ. Infanta Leonor Not yet recruiting
Madrid, Spain, 28031
Hosp. Univ. 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Hosp. Univ. I Politecni La Fe Not yet recruiting
Valencia, Spain, 46026
Hosp. de Manises Not yet recruiting
Valencia, Spain, 46940
United Kingdom
Russell's Hall Hospital Not yet recruiting
Dudley, United Kingdom, DY1 2HQ
Chapel Allerton Hospital Not yet recruiting
Leeds, United Kingdom, LS7 4SA
Barts Health NHS Trust Not yet recruiting
London, United Kingdom, E11 1NR
Royal Victoria Infirmary Not yet recruiting
Newcastle upon Tyne, United Kingdom, NE1 4LP
Salford Royal NHS Foundation Trust Not yet recruiting
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
Janssen-Cilag Ltd.
Investigators
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Study Director: Janssen-Cilag Ltd. Clinical Trial Janssen-Cilag Ltd.

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Responsible Party: Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT03998683     History of Changes
Other Study ID Numbers: CR108611
2018-003206-58 ( EudraCT Number )
CNTO1959PSO3013 ( Other Identifier: Janssen-Cilag Ltd. )
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs