NCT05004727

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. 1.Diminish MSKPDUS findings at 24 weeks, and
  2. 2.Significantly reduce or prevent the emergence of synovio-enthesial phenotype at year 2.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for phase_4

Timeline
30mo left

Started Feb 2022

Longer than P75 for phase_4

Geographic Reach
2 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Feb 2022Nov 2028

First Submitted

Initial submission to the registry

August 6, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

February 16, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

4.9 years

First QC Date

August 6, 2021

Last Update Submit

March 24, 2026

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score

    Score is defined by the ultrasound (General Electric Logiq E9 or E10) equipment, not calculated through a scale.

    Baseline, Week 24

Secondary Outcomes (13)

  • Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 2

    Year 2

  • Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 1

    Year 1

  • Severity of PsA at the time of synovio-entheseal development

    Year 2

  • Change in the ultrasound composite score of synovitis

    Baseline, week 24

  • Change in Madrid Sonographic Enthesis Index (MASEI) Score

    Baseline, week 24

  • +8 more secondary outcomes

Study Arms (3)

Guselkumab + Topicals (GUS)

EXPERIMENTAL
Drug: Guselkumab

Placebo + Topicals (PBO)

PLACEBO COMPARATOR
Drug: GuselkumabDrug: Placebo

Standard-of-Care Therapy (SOC)

NO INTERVENTION

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

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).

Guselkumab + Topicals (GUS)Placebo + Topicals (PBO)
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).

Placebo + Topicals (PBO)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

University of Rochester Medical Center (URMC)

Rochester, New York, 14623, United States

RECRUITING

Memorial University

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

RECRUITING

Women's College Research Institute, University of Toronto

Toronto, Ontario, M5S 1B2, Canada

RECRUITING

Related Publications (1)

  • 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 randomised, double-blind, placebo controlled multicentre trial. BMJ Open. 2022 Dec 23;12(12):e063650. doi: 10.1136/bmjopen-2022-063650.

    PMID: 36564123DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jose Scher, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Scher, MD

CONTACT

6465017400Jose.Scher@nyulangone.org

Stephanie Eichman

CONTACT

Stephanie.Eichman@nyulangone.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Participants, investigator staff, persons performing the assessments, and the CTT will remain blind to the identity of the treatment from the time of randomization until database lock.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 13, 2021

Study Start

February 16, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

November 2, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to jose.scher@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

CA(2)US(3)