Recruiting
Phase 4

Guselkumab

Sponsor:

NYU Langone Health

Code:

NCT05004727

Conditions

Psoriasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Guselkumab

Placebo

Study Details

Brief 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 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.

Conditions

Psoriasis

Study ID

NCT05004727

Start date

Feb 16, 2022

Status verified date

Mar, 2026

Completion date

Nov 2, 2028

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18 years old or older;
2. Both male \& female;
3. Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants);
4. Willing and able to provide informed consent;
5. 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:

1. Evidence of inflammatory joint pain, enthesitis and/or dactylitis on exam;
2. Current systemic immunosuppressive medication use (i.e., methotrexate, apremilast) at the time of enrollment or biologic therapy (ever);
3. RA seropositivity (mid-high RF/ACPA titers);
4. Current active malignancy;
5. History of symptomatic polyarticular OA or other joint conditions (such as RA, gout, etc) that may impair the ability to assess for PsA development
6. Conditions where initiation of guselkumab is prohibited in the prescribing information, including clinically important active infection and untreated latent tuberculosis;
7. Known hypersensitivity to the study agent.

Study Design

Enrollment

176 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Guselkumab + Topicals (GUS)

placebo comparator: Placebo + Topicals (PBO)

no intervention: Standard-of-Care Therapy (SOC)

In this third, non-randomized arm, patients would continue treatment with topical therapy or UVB, as part of our ongoing natural history of disease registries. This arm will include participants fulfilling RM-PsASon criteria but also those that do not (to serve as "negative" controls).

Interventions

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).

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 measure

  • Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score [ Time Frame: Baseline, Week 24 ]

Central Contacts and Locations

Central contacts

Jose Scher, MD

6465017400Jose.Scher@nyulangone.org

Stephanie Eichman

Stephanie.Eichman@nyulangone.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Joseph Merola, MD, MMSc

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Jose Scher, MD

Jose.Scher@nyulangone.org

Stephanie Eichman, EdD

Stephanie.Eichman@nyulangone.org

Principal Investigator:

Jose Scher, MD

University of Rochester Medical Center (URMC)

Recruiting

Rochester, New York, United States, 14623

Contacts

Christopher_Ritchlin@urmc.rochester.edu

Principal Investigator:

Christopher Ritchlin, MD, MPH

Memorial University

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1C 5B8

Contacts

Wayne Gulliver, MD

drgulliver@newlabresearch.com

Principal Investigator:

Wayne Gulliver, MD, FRCPC

Women's College Research Institute, University of Toronto

Recruiting

Toronto, Ontario, Canada, M5S 1B2

Contacts

Lihi Eder, MD PhD

lihi.eder@wchospital.ca

Principal Investigator:

Lihi Eder, MD PhD

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.