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

Sponsor
Janssen-Cilag Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03998683
Collaborator
(none)
117
Enrollment
26
Locations
2
Arms
26.9
Actual Duration (Months)
4.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
117 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
Actual Study Start Date :
Sep 3, 2019
Actual Primary Completion Date :
Mar 2, 2021
Actual Study Completion Date :
Nov 30, 2021

Arms and Interventions

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 Names:
  • 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 Names:
  • CNTO1959

    • Drug: Placebo
    Placebo will be administered as SC injection.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants who Achieve Palmoplantar Pustulosis Psoriasis Area and Severity Index 75 (ppPASI75) Response at Week 16 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Bordeaux - Hopital St Andre Bordeaux France 33000
    2 Hôpital Edouard Herriot Lyon Cedex 03 France 69437
    3 CHU de Nice Hopital de l Archet Nice France 06200
    4 Hopital Charles Nicolle Rouen France 76031
    5 Fachklinik Bad Bentheim Bad Bentheim Germany 48455
    6 University Hospital Dresden Dresden Germany 01307
    7 Universitatsklinikum Frankfurt Frankfurt am Main Germany 60590
    8 MensingDerma research GmbH Hamburg Germany 22391
    9 Universitätsklinikum Schleswig Holstein Campus Lübeck Lubeck Germany 23538
    10 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz Germany 55131
    11 Universitaetsklinikum Muenster Muenster Germany 48149
    12 Centrovital Witten Germany 58453
    13 AOU di Cagliari Cagliari Italy 09124
    14 P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele' Catania Italy 95123
    15 Ospedale Santa Chiara AO Universitaria Pisana Pisa Italy 56126
    16 Istituto Clinico Humanitas Rozzano Italy 20089
    17 Hosp. Univ. Germans Trias I Pujol Badalona Spain 08916
    18 Hosp. Univ. Infanta Leonor Madrid Spain 28031
    19 Hosp. Univ. 12 de Octubre Madrid Spain 28041
    20 Hosp. Univ. I Politecni La Fe Valencia Spain 46026
    21 Hosp. de Manises Valencia Spain 46940
    22 Russell's Hall Hospital Dudley United Kingdom DY1 2HQ
    23 Chapel Allerton Hospital Leeds United Kingdom LS7 4SA
    24 Barts Health NHS Trust London United Kingdom E11 1NR
    25 Royal Victoria Infirmary Newcastle upon Tyne United Kingdom NE1 4LP
    26 Salford Royal NHS Foundation Trust Salford United Kingdom M6 8HD

    Sponsors and Collaborators

    • Janssen-Cilag Ltd.

    Investigators

    • Study Director: Janssen-Cilag Ltd. Clinical Trial, Janssen-Cilag Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen-Cilag Ltd.
    ClinicalTrials.gov Identifier:
    NCT03998683
    Other Study ID Numbers:
    • CR108611
    • 2018-003206-58
    • CNTO1959PSO3013
    First Posted:
    Jun 26, 2019
    Last Update Posted:
    Jan 3, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    No Results Posted as of Jan 3, 2022