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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 January 2022 |
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Main ID: |
NCT03998683 |
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Date of registration:
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25/06/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis
G-PLUS |
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Scientific title:
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A Phase 3b, Multicenter, Interventional, Randomized, Placebo-controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis |
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Date of first enrolment:
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September 3, 2019 |
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Target sample size:
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117 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03998683 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Germany
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Italy
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Spain
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United Kingdom
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Contacts
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Name:
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Janssen-Cilag Ltd. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen-Cilag Ltd. |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psoriasis
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Intervention(s)
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Drug: Guselkumab 100 mg
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Drug: Placebo
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Primary Outcome(s)
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Percentage of Participants who Achieve Palmoplantar Pustulosis Psoriasis Area and Severity Index 75 (ppPASI75) Response at Week 16
[Time Frame: Week 16]
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Secondary Outcome(s)
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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]
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Number of Participants with Adverse Event (AEs) as a Measure of Safety and Tolerability
[Time Frame: Up to 56 weeks]
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Percentage of Participants Achieving PASI 75 Score at Weeks 16, 24 and 48
[Time Frame: Weeks 16, 24 and 48]
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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]
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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]
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Percentage of Participants Achieving PASI 100 at Weeks 16, 24 and 48
[Time Frame: Weeks 16, 24 and 48]
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Percentage of Participants who Achieve ppPASI90 response at Weeks 24 and 48
[Time Frame: Weeks 24 and 48]
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Change from Baseline in absolute PASI Score at Weeks 16, 24 and 48
[Time Frame: Baseline, Weeks 16, 24 and 48]
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Change from Baseline in Body Surface Area (BSA) Score at Weeks 16, 24 and 48
[Time Frame: Baseline and Weeks 16, 24 and 48]
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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]
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Percentage of Participants Achieving PASI 90 Score at Weeks 16, 24 and 48
[Time Frame: Weeks 16, 24 and 48]
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Percentage of Participants who Achieve ppPASI100 response at Weeks 24 and 48
[Time Frame: Weeks 24 and 48]
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Percentage of Participants who Achieve ppPASI75 response at Weeks 24 and 48
[Time Frame: Weeks 24 and 48]
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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]
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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]
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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]
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Secondary ID(s)
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2018-003206-58
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CR108611
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CNTO1959PSO3013
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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