Psoriasis Clinical Trial
Multi-Center PAMPA Study
Summary
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 our 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:
Diminish MSKPDUS findings at 24 weeks, and
Significantly reduce or prevent the emergence of synovio-enthesial phenotype at year 2.
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 5 Locations for this study
Boston Massachusetts, 02115, United States More Info
Contact
Principal Investigator
New York New York, 10016, United States More Info
Principal Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Rochester New York, 14623, United States More Info
Contact
Sub-Investigator
Sub-Investigator
Principal Investigator
Saint John's Newfoundland and Labrador, A1C 5, Canada More Info
Sub-Investigator
Principal Investigator
Toronto Ontario, M5S 1, Canada More Info
Principal Investigator
Sub-Investigator
Sub-Investigator
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.