Psoriasis Clinical Trial
Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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There are 168 Locations for this study
Birmingham Alabama, 35205, United States
Flagstaff Arizona, 86001, United States
Mesa Arizona, 85210, United States
Phoenix Arizona, 85032, United States
Phoenix Arizona, 85037, United States
Sun City Arizona, 85351, United States
Tucson Arizona, 85723, United States
Searcy Arkansas, 72143, United States
Huntington Beach California, 92648, United States
Thousand Oaks California, 91360, United States
Tujunga California, 91042, United States
Danbury Connecticut, 06810, United States
Bay Pines Florida, 33744, United States
Clearwater Florida, 33765, United States
DeBary Florida, 32713, United States
Ocoee Florida, 34761, United States
Plantation Florida, 33324, United States
Tampa Florida, 33606, United States
Zephyrhills Florida, 33542, United States
Chicago Illinois, 60640, United States
Skokie Illinois, 60076, United States
Monroe Louisiana, 71203, United States
Baltimore Maryland, 21224, United States
Hagerstown Maryland, 21740, United States
Lansing Michigan, 48911, United States
Okemos Michigan, 48864, United States
Saint Clair Shores Michigan, 48081, United States
Eagan Minnesota, 55121, United States
Saint Louis Missouri, 63141, United States
Voorhees New Jersey, 08043, United States
Albuquerque New Mexico, 87102, United States
Las Cruces New Mexico, 88011, United States
Orchard Park New York, 14127, United States
Charlotte North Carolina, 28211, United States
Vandalia Ohio, 45377, United States
Oklahoma City Oklahoma, 73103, United States
Oklahoma City Oklahoma, 73116, United States
Memphis Tennessee, 38119, United States
Colleyville Texas, 76034, United States
Corpus Christi Texas, 78404, United States
Dallas Texas, 75231, United States
Fort Worth Texas, 76107, United States
Lubbock Texas, 79424, United States
Mesquite Texas, 75150, United States
Plano Texas, 75024, United States
The Woodlands Texas, 77382, United States
Tomball Texas, 77375, United States
Waco Texas, 76710, United States
Spokane Washington, 99204, United States
Beckley West Virginia, 25801, United States
Buenos Aires , 1428, Argentina
Buenos Aires , C1417, Argentina
Buenos Aires , C1426, Argentina
Ciudad Autonoma de Buenos Aires , C1061, Argentina
Ciudad Autónoma de Buenos Aires , C1015, Argentina
Ciudad de Mendoza , M5631, Argentina
San Miguel De Tucuman , T4000, Argentina
Hobart , 7000, Australia
Liverpool , 2170, Australia
Melbourne , 3053, Australia
Melbourne , 3128, Australia
Pleven , 5804, Bulgaria
Plovdiv , 4001, Bulgaria
Plovdiv , 4001, Bulgaria
Ruse , 7002, Bulgaria
Sfia , 1612, Bulgaria
Sofia , 1606, Bulgaria
Sofia , 1750, Bulgaria
Sofia , 1770, Bulgaria
Sofia , 1794, Bulgaria
Breclav , 691 0, Czechia
Hlucin , 748 0, Czechia
Ostrava , 70800, Czechia
Pardubice , 53002, Czechia
Praha 2 , 128 5, Czechia
Uherske Hradiste , 68601, Czechia
Zlin , 76001, Czechia
Budapest , 1023, Hungary
Budapest , 1152, Hungary
Debrecen , 4031, Hungary
Gyula , 5700, Hungary
Kistarcsa , 2143, Hungary
Szeged , 6725, Hungary
Szekesfehervar , H-800, Hungary
Veszprem , 8200, Hungary
Haifa , 31048, Israel
Haifa , 31096, Israel
Hifa , 34362, Israel
Kfar-Sava , 44281, Israel
Ramat Gan , 52656, Israel
Batu Caves , 68100, Malaysia
George Town , 10990, Malaysia
Ipoh , 30450, Malaysia
Seremban , 70300, Malaysia
Bytom , 41-90, Poland
Elblag , 82-30, Poland
Krakow , 30 00, Poland
Krakow , 30 14, Poland
Krakow , 31-51, Poland
Lodz , 90 26, Poland
Lodz , 90-33, Poland
Nadarzyn , 05 83, Poland
Nowa Sol , 67-10, Poland
Poznan , 61 11, Poland
Poznan , 61-29, Poland
Swidnik , 21-04, Poland
Warsaw , 00-87, Poland
Warszawa , 02-11, Poland
Warszawa , 02-66, Poland
Wrocław , 51-68, Poland
San Juan , 00917, Puerto Rico
San Juan , 00918, Puerto Rico
San Juan , 00927, Puerto Rico
Barnaul , 65603, Russian Federation
Chelyabinsk , 45407, Russian Federation
Chelyabinsk , 45409, Russian Federation
Kemerovo , 65000, Russian Federation
Kemerovo , 65007, Russian Federation
Korolev , 14106, Russian Federation
Krasnodar , 35002, Russian Federation
Krasnoyarsk , 66012, Russian Federation
Moscow , 11541, Russian Federation
Moscow , 11552, Russian Federation
Moscow , 12911, Russian Federation
Orenburg , 46000, Russian Federation
Rostov , 34400, Russian Federation
Saratov , 41005, Russian Federation
Smolensk , 21402, Russian Federation
St. Petersburg , 19006, Russian Federation
St. Petersburg , 19415, Russian Federation
Tolyatti , 44584, Russian Federation
Tula , 30005, Russian Federation
Ufa , 45000, Russian Federation
Barakaldo , 48903, Spain
Madrid , 28006, Spain
Madrid , 28223, Spain
Málaga , 29011, Spain
Santiago de Compostela , 15702, Spain
Sevilla , 41013, Spain
Valencia , 46010, Spain
Adana , 01370, Turkey
Ankara , 06010, Turkey
Ankara , 06800, Turkey
Ankara , 6100, Turkey
Antalya , 7059, Turkey
Bursa , 16059, Turkey
Denizli , 20070, Turkey
Eskisehir , 26040, Turkey
Istanbul , 34093, Turkey
Istanbul , 34098, Turkey
Istanbul , 34865, Turkey
Istanbul , 34899, Turkey
Kocaeli , 41380, Turkey
Konya , 42080, Turkey
Cherkasy , 18009, Ukraine
Kharkiv , 61204, Ukraine
Khmelnytsky , 29000, Ukraine
Kryvyi Rih , 50056, Ukraine
Kyiv , 01135, Ukraine
Kyiv , 02081, Ukraine
Kyiv , 02125, Ukraine
Kyiv , 03049, Ukraine
Kyiv , 03151, Ukraine
Kyiv , 04050, Ukraine
Lutsk , 43005, Ukraine
Odessa , 65026, Ukraine
Poltava , 36011, Ukraine
Vinnytsya , 21018, Ukraine
Zaporizhzhya , 69600, Ukraine
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