A Phase 3b Multicenter Randomized Double-blind Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants with Activ

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Active Psoriatic Arthritis.
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy
    2. Have a diagnosis of PsA for at least 6 months prior to the first administration of study intervention and meet ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria at screening
    3. Have active PsA as defined by having at least three swollen joints and three tender joints at screening and at baseline and CRP = 0.3 mg/dL at screening from the central laboratory
    4. Have = 2 joints with erosions on baseline radiographs of the hands and feet as determined by central read
    5. 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
    6. Have active plaque psoriasis, with at least one psoriatic plaque of = 2cm diameter and/or nail changes consistent with psoriasis
    7. If currently using non-biologic Disease-modifying antirheumatic drugs (DMARDs), participants should have started treatment at least 3 months and the dose must be stable for at least 4 weeks before first administration of study intervention and should have no serious toxic side effects attributable to the non-biologic DMARD
    8. If currently not using MTX, SSZ, or HCQ, must not have received for at least 4 weeks before first administration of study intervention. If currently not using LEF, must not have received for at least 12 weeks before first administration of study intervention
    9. If using NSAIDs or other analgesics for PsA at baseline, participants must be on a stable dose for at least 2 weeks prior to the first administration of study intervention. If currently not using NSAIDs or other analgesics for PsA, must not have received NSAIDs or other analgesics for PsA within 2 weeks prior to the first administration of study intervention.
    10. If using oral corticosteroids at baseline, participants must be on a stable dose equivalent to =10 mg of prednisone/day for at least 2 weeks prior to the first administration of study intervention. If not currently using oral corticosteroids, the participant must not have received oral corticosteroids within 2 weeks prior to the first administration of study intervention.
    11. A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Week 0
    12. A woman of childbearing potential must use highly effective contraceptive methods
    13. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 12 weeks after receiving the last administration of study intervention.
    14. All men must agree not to donate sperm from the first administration of study intervention through at least 12 weeks after receiving the last administration of study intervention.
    15. A man who is sexually active with a woman of childbearing potential and who has not had a vasectomy must agree to use a barrier method of birth control
    16. Have no history of latent or active TB before screening
    17. Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention
    18. Agree not to receive a bacillus Calmette-Guérin (BCG) vaccination during the study, and within 12 weeks after the last administration of study intervention
    19. Agree to avoid prolonged sun exposure and agree not to use of tanning booths or other ultraviolet (UV) light sources during study
    20. Be willing and able to adhere to the prohibitions and restrictions specified in this protocol

You may not be eligible for this study if the following are true:

    1. Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients
    2. Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy
    3. Has the arthritis mutilans subset of PsA
    4. Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab, anti-TNFa agents (such as adalimumab, etanercept, infliximab, golimumab SC or intravenous (IV), certolizumab pegol, or their respective biosimilars), tildrakizumab, ixekizumab, brodalumab, risankizumab or other investigative biologic treatment for PsA or psoriasis
    5. Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (JAK) inhibitor
    6. Has received non-biologic DMARDs other than MTX, SSZ, HCQ, LEF, within 4 weeks before the first administration of study intervention.
    7. Is receiving 3 or more non-biologic DMARDs
    8. Has received phototherapy or any systemic medications/treatments that could affect psoriasis evaluations
    9. Has used topical medications/treatments that could affect psoriasis evaluations
    10. Has received epidural, intra-articular, intramuscular (IM), or IV corticosteroids
    11. Has received lithium within 4 weeks of the first administration of study intervention
    12. Has received an experimental antibody or biologic therapy
    13. Has unstable suicidal ideation or suicidal behavior in the last 6 months
    14. Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
    15. Has unstable cardiovascular disease
    16. Currently has a malignancy or has a history of malignancy within 5 years prior to screening
    17. Has a history of lymphoproliferative disease
    18. Has a history of chronic or recurrent infectious disease
    19. Has a transplanted organ
    20. Has a history of an infected joint prosthesis
    21. Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis) or has been hospitalized or received IV antibiotics for an infection within 2 months prior to screening
    22. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments.



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