Multi-Center PAMPA Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
NYU Langone Health
Study ID
NCT05004727
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    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 — DRUG
    • 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).

Study Details

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.

Key Dates

Start date
Feb 16, 2022
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Nov 2, 2028

Study Design

Enrollment
176 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Jeffrey Sparks, MD
Joseph Merola, MD, MMSc (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Jose Scher, MD
[email protected]
Stephanie Eichman, EdD
[email protected]
Jose Scher, MD (PRINCIPAL_INVESTIGATOR)
Andrea Neimann, MD, MSCE (SUB_INVESTIGATOR)
Jonathan Samuels, MD (SUB_INVESTIGATOR)
Rebecca Haberman, MD, MSCI (SUB_INVESTIGATOR)
Michael Toprover, MD (SUB_INVESTIGATOR)
Andrea Troxel, ScD (SUB_INVESTIGATOR)
Jiyuan Hu, PhD (SUB_INVESTIGATOR)
University of Rochester Medical Center (URMC)RochesterNew York14623
Christopher Ritchlin, MD, MPH
[email protected]
Francisco Tausk, MD (SUB_INVESTIGATOR)
Ralf Thiele, MD (SUB_INVESTIGATOR)
Christopher Ritchlin, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Brigham and Women's Hospital· Boston, MANYU Langone Health· New York, NYUniversity of Rochester Medical Center (URMC)· Rochester, NY

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