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

Last updated: April 2, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Joint Injuries

Psoriatic Arthritis

Treatment

Guselkumab

Placebo

Clinical Study ID

NCT04936308
CR109039
CNTO1959PSA3005
2021-000482-32
2023-504715-33-00
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of active psoriatic arthritis (PsA) for at least 6 months beforethe first administration of study agent and meet Classification criteria forPsoriatic Arthritis (CASPAR) at screening

  • Have active PsA as defined by: at least 3 swollen joints and at least 3 tenderjoints at screening and at baseline; and C-reactive protein (CRP) greater than orequal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening from the centrallaboratory

  • Have at least one of the following PsA subsets: distal interphalangeal jointinvolvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetricperipheral 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 historyof 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 treatmentwith one prior anti-TNF alpha agent

Exclusion

Exclusion Criteria:

  • Has other inflammatory diseases that might confound the evaluations of benefit ofguselkumab therapy in the treatment of PsA, including but not limited to rheumatoidarthritis, ankylosing spondylitis/nonradiographic axial spondyloarthritis, systemiclupus erythematosus, or Lyme disease

  • Has received more than 1 prior anti-tumor necrosis factor (TNF) alpha agent (orbiosimilars)

  • Has ever received Janus kinase (JAK) inhibitor including but not limited totofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or anyother investigational JAK inhibitor

  • Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention

  • Has known allergies, hypersensitivity, or intolerance to guselkumab or itsexcipients

  • Has a history of chronic or recurrent infectious disease, including but not limitedto chronic renal infection, chronic chest infection (example, bronchiectasis),recurrent urinary tract infection (example, recurrent pyelonephritis or chronicnon-remitting cystitis), fungal infection (example, mucocutaneous candidiasis), oropen, draining, or infected skin wounds or ulcers

Study Design

Total Participants: 453
Treatment Group(s): 2
Primary Treatment: Guselkumab
Phase: 3
Study Start date:
September 28, 2021
Estimated Completion Date:
July 16, 2026

Study Description

PsA is a chronic, immune-mediated inflammatory disease characterized by peripheral joint inflammation, enthesitis, dactylitis, axial disease, and the skin lesions associated with psoriasis. Guselkumab is a fully human monoclonal antibody (mAb) that binds to p19 protein subunit of interleukin (IL)-23 and blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling, subsequent activation, and cytokine production. The primary hypothesis of this study is that guselkumab is superior to placebo as assessed by the proportion of participants who had an inadequate response (IR) and/or intolerance to one prior anti-tumor necrosis factor (anti-TNF) achieving an American College of Rheumatology 20 (ACR 20) response at Week 24. This study will consist of a screening phase (up to 6 weeks), blinded treatment phase (approximately up to 2 years), which includes a placebo-controlled period from Week 0 to Week 24, and an active-controlled treatment phase from Week 24 to Week 100, and safety follow-up phase (Week 112). Safety assessments will include physical examinations, vital signs, height, weight, electrocardiograms, and clinical safety laboratory assessments. The total duration of the study will be up to 118 weeks.

Connect with a study center

  • Centro Privado de Medicina Familiar

    Buenos Aires, C1417EYG
    Argentina

    Site Not Available

  • Cosultorios Reumatologógicos Pampa

    Buenos Aires, 1428
    Argentina

    Site Not Available

  • Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

    Buenos Aires, C1426BOS
    Argentina

    Site Not Available

  • CIPREC

    Ciudad Autonoma de Buenos Aires, C1061AAS
    Argentina

    Site Not Available

  • OMI

    Ciudad Autónoma de Buenos Aires, C1015ABO
    Argentina

    Site Not Available

  • Instituto de Reumatología Mendoza

    Ciudad de Mendoza, M5631AHF
    Argentina

    Site Not Available

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    San Miguel De Tucuman, T4000AXL
    Argentina

    Site Not Available

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    San Miguel De Tucuman, T4000AXL
    Argentina

    Active - Recruiting

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    Camberwell, 3124
    Australia

    Site Not Available

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    Footscray, 3011
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    Hobart, 7000
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    Kogarah, 2217
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    Liverpool, 2170
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    Melbourne, 3128
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    Melbourne, 3053
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    Woodville South, 5011
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    Poznan, 60 324
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    Warszawa, 02 665
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    Warszawa, 02 118
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    Warszawa, 02-118
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    Warszawa, 02-118
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  • WroMedica I Bielicka A Strzalkowska s c

    Wroclaw, 51 685
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    Wrocław, 51-685
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    Wrocław, 51-685
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    San Juan, 00918
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    Chelyabinsk, 454092
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    Kemerovo, 650000
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    Kirov, 610027
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    Korolev, 141060
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    Krasnodar, 350020
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    Krasnoyarsk, 660123
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    United States

    Completed

  • Arizona Arthritis and Rheumatology Research PLLC

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Arizona Arthritis and Rheumatology Research, PLLC

    Phoenix, Arizona 85037
    United States

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Associates

    Sun City, Arizona 85351
    United States

    Active - Recruiting

  • Arizona Arthritis and Rheumatology Associates

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Southern Arizona VA Healthcare System

    Tucson, Arizona 85723
    United States

    Site Not Available

  • Unity Health-White County Medical Center

    Searcy, Arkansas 72143
    United States

    Site Not Available

  • Medvin Clinical Research

    Covina, California 91722
    United States

    Site Not Available

  • Newport Huntington Medical Group

    Huntington Beach, California 92648
    United States

    Site Not Available

  • Medvin Clinical Research

    Thousand Oaks, California 91360
    United States

    Site Not Available

  • Medvin Clinical Research

    Tujunga, California 91042
    United States

    Site Not Available

  • Clinical Research Center of Connecticut

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Bay Pines VA Healthcare System

    Bay Pines, Florida 33744
    United States

    Site Not Available

  • Clinical Research of West Florida

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Omega Research Consultants

    DeBary, Florida 32713
    United States

    Site Not Available

  • The Center for Arthritis and Rheumatic Diseases

    Miami, Florida 33173
    United States

    Site Not Available

  • Advanced Clinical Research of Orlando

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Integral Rheumatology & Immunology Specialists

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Integral Rheumatology And Immunology Specialists

    Plantation, Florida 33324
    United States

    Site Not Available

  • Clinical Research of West Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida 33542
    United States

    Site Not Available

  • Augusta University

    Augusta, Georgia 30912-3125
    United States

    Site Not Available

  • Great Lakes Clinical Trials

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Clinic of Robert Hozman

    Skokie, Illinois 60076
    United States

    Site Not Available

  • The Arthritis and Diabetes Clinic

    Monroe, Louisiana 71203
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Klein & Associates, M.D., P.A.

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Klein And Associates M D P A

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Great Lakes Center of Rheumatology

    Lansing, Michigan 48911
    United States

    Site Not Available

  • Arthritis and Rheumatology Center of MI

    Okemos, Michigan 48864
    United States

    Site Not Available

  • Clinical Research Institute of Michigan, LLC

    Saint Clair Shores, Michigan 48081
    United States

    Site Not Available

  • St. Paul Rheumatology P A

    Eagan, Minnesota 55121
    United States

    Site Not Available

  • St. Paul Rhuematology P A

    Eagan, Minnesota 55121
    United States

    Site Not Available

  • St. Paul Rhuematology, P.A.

    Eagan, Minnesota 55121
    United States

    Active - Recruiting

  • Arthritis Consultants

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Physician Research Collaboration

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Excel Clinical Research

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Arthritis Rheumatic And Back Disease Associates

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Albuquerque Center for Rheumatology

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Arthritis and Osteoperosis Associates of New Mexico

    Las Cruces, New Mexico 88011
    United States

    Site Not Available

  • VA NY Harbor Healthcare System

    Brooklyn, New York 11209
    United States

    Site Not Available

  • Buffalo Rheumatology and Medicine PLLC

    Orchard Park, New York 14127
    United States

    Site Not Available

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • STAT Research, Inc.

    Vandalia, Ohio 45377
    United States

    Site Not Available

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Rheumatology Associates of Oklahoma

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • Dr. Ramesh Gupta

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Tekton Research Inc.

    Austin, Texas 78745
    United States

    Site Not Available

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas 76034
    United States

    Site Not Available

  • Adriana Pop Moody MD Clinic PA

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • Metroplex Clinical Research Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • Precision Comprehensive Clinical Research Solutions

    Fort Worth, Texas 76107
    United States

    Site Not Available

  • Precision Comprehensive Clinical Research Solutions

    Grapevine, Texas 76051
    United States

    Site Not Available

  • West Texas Clinical Research

    Lubbock, Texas 79424
    United States

    Site Not Available

  • Southwest Rheumatology Research LLC

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Texas Rheumatology Care

    Plano, Texas 75024
    United States

    Site Not Available

  • Epic Medical Research

    Red Oak, Texas 75154
    United States

    Site Not Available

  • Advanced Rheumatology of Houston

    The Woodlands, Texas 77382
    United States

    Site Not Available

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Site Not Available

  • Arthritis & Osteoporosis Clinic

    Waco, Texas 76710
    United States

    Site Not Available

  • Arthritis And Osteoporosis Clinic

    Waco, Texas 76710
    United States

    Site Not Available

  • Arthritis Northwest PLLC

    Spokane, Washington 99204
    United States

    Site Not Available

  • Rheumatology & Pulmonary Clinic

    Beckley, West Virginia 25801
    United States

    Active - Recruiting

  • Rheumatology and Pulmonary Clinic

    Beckley, West Virginia 25801
    United States

    Site Not Available

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