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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

350

Study ID:

NCT05004727

Recruitment Status:

Recruiting

Sponsor:

NYU Langone Health

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There are 5 Locations for this study

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Brigham and Women's Hospital
Boston Massachusetts, 02115, United States More Info
Joseph Merola, MD, MMSc
Contact
Joseph Merola, MD, MMSc
Principal Investigator
NYU Langone Health
New York New York, 10016, United States More Info
Jose Scher, MD
Contact
[email protected]
Amina Abdelaziz, EdD
Contact
[email protected]
Jose Scher, MD
Principal Investigator
Andrea Neimann, MD, MSCE
Sub-Investigator
Jonathan Samuels, MD
Sub-Investigator
Rebecca Haberman, MD, MSCI
Sub-Investigator
Rebecca Blank, MD, PhD
Sub-Investigator
Michael Toprover, MD
Sub-Investigator
Andrea Troxel, ScD
Sub-Investigator
Jiyuan Hu, PhD
Sub-Investigator
University of Rochester Medical Center (URMC)
Rochester New York, 14623, United States More Info
Christopher Ritchlin, MD, MPH
Contact
Francisco Tausk, MD
Sub-Investigator
Ralf Thiele, MD
Sub-Investigator
Christopher Ritchlin, MD, MPH
Principal Investigator
Memorial University
Saint John's Newfoundland and Labrador, A1C 5, Canada More Info
Wayne Gulliver, MD
Contact
[email protected]
Proton Rahman, MD
Sub-Investigator
Wayne Gulliver, MD, FRCPC
Principal Investigator
Women's College Research Institute, University of Toronto
Toronto Ontario, M5S 1, Canada More Info
Lihi Eder, MD PhD
Contact
[email protected]
Lihi Eder, MD PhD
Principal Investigator
Vincent Piguet, MD PhD
Sub-Investigator
Jensen Yeung, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

350

Study ID:

NCT05004727

Recruitment Status:

Recruiting

Sponsor:


NYU Langone Health

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