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Recruiting NCT05004727

Multi-Center PAMPA Study

Phase IV Interventional Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Guselkumab, Placebo.
Who it may be relevant to
Registry conditions: Psoriasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort

Overview

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.

Interventions

  • Drug 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).
  • Drug 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).

Primary outcome measures

  • Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score [Time frame: Baseline, Week 24]
Secondary outcome measures (12)
  • Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 2 [Time frame: Year 2]
  • Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 1 [Time frame: Year 1]
  • Severity of PsA at the time of synovio-entheseal development [Time frame: Year 2]
  • Change in the ultrasound composite score of synovitis [Time frame: Baseline, week 24]
  • Change in Madrid Sonographic Enthesis Index (MASEI) Score [Time frame: Baseline, week 24]
  • Psoriasis Body Surface Area (BSA) [Time frame: Week 24]
  • Achieved IGA mod 2011 Score [Time frame: Week 24]
  • Change in Functional Assessment of Chronic Illness Therapy (FACIT) Scale [Time frame: Week 24]
  • Change in EuroQol-5D (EQ-5D) Score [Time frame: Baseline, Week 24]
  • Change in EuroQol-5D (EQ-5D) Score [Time frame: Baseline, Year 2]
  • Change in International Dermatology Outcome Measures - Musculoskeletal -8 (IDEOM-MSK-8) Score [Time frame: Baseline, Week 24]
  • Change in Ultrasound (US) Score [Time frame: Baseline, Week 24]

Eligibility criteria

Inclusion criteria

  • 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 consent;
  • 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 criteria

  • Evidence of inflammatory joint pain, enthesitis and/or dactylitis on exam;
  • Current systemic immunosuppressive medication use (i.e., methotrexate, apremilast) at the time of enrollment 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;
  • Known hypersensitivity to the study agent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Brigham and Women's Hospital — Boston
  • NYU Langone Health — New York
  • University of Rochester Medical Center (URMC) — Rochester
Canada · 2 centers
  • Memorial University — St. John's
  • Women's College Research Institute, University of Toronto — Toronto

Publications

  • Haberman RH, MacFarlane KA, Catron S, Samuels J, Blank RB, Toprover M, Uddin Z, Hu J, Castillo R, Gong C, Qian K, Piguet V, Tausk F, Yeung J, Neimann AL, Gulliver W, Thiele RG, Merola JF, Ogdie A, Rahman P, Chakravarty SD, Eder L, Ritchlin CT, Scher JU. Efficacy of guselkumab, a selective IL-23 inhibitor, in Preventing Arthritis in a Multicentre Psoriasis At-Risk cohort (PAMPA): protocol of a rand PMID 36564123

Identifiers

NCT: NCT05004727 · 20-01158

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗