Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.

Key facts

Study ID

NCT04936308

Run by

Janssen Research & Development, LLC

People needed

453

Starts

2021-09-28

Expected to finish

2026-07-16

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of active psoriatic arthritis (PsA) for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
• Have active PsA as defined by: at least 3 swollen joints and at least 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory
• Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
• Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeters (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
• Have an inadequate response and/or intolerance to anti-tumor necrosis factor alpha (TNF alpha) therapy, defined as presence of active PsA despite previous treatment with one prior anti-TNF alpha agent

You may not qualify if…

• Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy in the treatment of PsA, including but not limited to rheumatoid arthritis, ankylosing spondylitis/nonradiographic axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease
• Has received more than 1 prior anti-tumor necrosis factor (TNF) alpha agent (or biosimilars)
• Has ever received Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor
• Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention
• Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
• Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (example, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

Where it is running

• Arizona Arthritis and Rheumatology Research PLLC 2 — Avondale, Arizona, United States
• Arizona Arthritis and Rheumatology Research PLLC 3 — Flagstaff, Arizona, United States
• Arizona Arthritis and Rheumatology Research PLLC — Mesa, Arizona, United States
• Arizona Arthritis and Rheumatology Research PLLC 1 — Phoenix, Arizona, United States
• Arizona Arthritis and Rheumatology Associates — Sun City, Arizona, United States
• Southern Arizona VA Healthcare System — Tucson, Arizona, United States
• Unity Health-White County Medical Center — Searcy, Arkansas, United States
• Newport Huntington Medical Group — Huntington Beach, California, United States
• Medvin Clinical Research 2 — Thousand Oaks, California, United States
• Medvin Clinical Research — Tujunga, California, United States
• Clinical Research Center of Connecticut — Danbury, Connecticut, United States
• Bay Pines VA Healthcare System — Bay Pines, Florida, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• Omega Research Consultants — DeBary, Florida, United States
• Advanced Clinical Research of Orlando — Ocoee, Florida, United States
• Integral Rheumatology And Immunology Specialists — Plantation, Florida, United States
• Clinical Research of West Florida 1 — Tampa, Florida, United States
• Florida Medical Clinic, P.A. — Zephyrhills, Florida, United States
• Great Lakes Clinical Trials — Chicago, Illinois, United States
• Clinic of Robert Hozman — Skokie, Illinois, United States
• The Arthritis and Diabetes Clinic — Monroe, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Klein And Associates M D P A — Hagerstown, Maryland, United States
• Great Lakes Center of Rheumatology — Lansing, Michigan, United States
• Arthritis Associates — Mountain Brook, Alabama, United States

Full record on ClinicalTrials.gov

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