Testing Guselkumab against a placebo for psoriasis
Official title: Multi-Center PAMPA Study
Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort
- Phase 4
- 3 groups
- Sites in St. John's and Toronto
- Recruiting
Interventions
- Medication
Guselkumab
Guselkumab 100 mg 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (month 0 to month 24 for arm 1; week 24 to month 24 for arm 2).
- Medication
Placebo
• Placebo to Guselkumab 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (Month 0 to Week 20 for Arm 2).
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
Memorial University
St. John's, Newfoundland and Labrador
- Recruiting
Women's College Research Institute, University of Toronto
Toronto, Ontario
Eligibility Criteria
See who this study is looking for12 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +18 years old or older;
- +Both male \& female;
- +Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants);
- +Willing and able to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →;
- +Fulfillment of HR-PsO criteria (Psoriasis (PsO) patients will meet the definition of HR if they fulfill the following criteria: a) PsO duration \>2 years and Psoriasis Body Surface Area (BSA) \>3% and positive imaging findings in MSKPDUS defined as a RM-PsASon score of \>3.36
Exclusion
- −Known hypersensitivity to the study agent.
- −Evidence of inflammatory joint pain, enthesitis and/or dactylitis on exam;
- −Current systemic immunosuppressive medication use (i.e., methotrexate, apremilast) at the time of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → or biologic therapy (ever);
- −RA seropositivity (mid-high RF/ACPA titers);
- −Current active malignancy;
- −History of symptomatic polyarticular OA or other joint conditions (such as RA, gout, etc) that may impair the ability to assess for PsA development
- −Conditions where initiation of guselkumab is prohibited in the prescribing information, including clinically important active infection and untreated latent tuberculosis;
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives Guselkumab.
Registry label: A: Guselkumab + Topicals (GUS)
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo, together with one or more of: Guselkumab.
Registry label: B: Placebo + Topicals (PBO)
Group C receives no study treatment and is followed for comparison.
Registry label: C: Standard-of-Care Therapy (SOC)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 176 people.
The study is currently expected to finish around November 2028.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Week 24.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Week 24.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05004727 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About GuselkumabDrug
Guselkumab 100 mg 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (month 0 to month 24 for arm 1; week 24 to month 24 for arm 2).
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
• Placebo to Guselkumab 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (Month 0 to Week 20 for Arm 2).
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Week 24.
The study as a whole is currently expected to finish around 2028-11-02.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 176 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: St. John's, Newfoundland and Labrador, Canada; Toronto, Ontario, Canada; New York, New York, United States; Rochester, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This is a multi-center (North-America), randomized, double-blind, placebo-controlled, wait-list, interventional, preventive trial of guselkumab in high-risk psoriasis patients compared to non-biologic standard of care. The primary objective of the proposed trial will be to test the hypothesis that a prolonged, unresolved skin inflammation coupled with musculoskeletal power-doppler ultrasound (MSKPDUS) abnormalities driven by IL-23 increase the risk for transition into PsA and that an intervention that targets one of these pivotal molecules (i.e., Guselkumab) will: 1. Diminish MSKPDUS findings at 24 weeks, and 2. Significantly reduce or prevent the emergence of synovio-enthesial phenotype at year 2.
Other Sites (2)
NYU Langone Health
New York, New York, United States
University of Rochester Medical Center (URMC)
Rochester, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.