Psoriasis Clinical Trial
A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
Summary
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) axial disease by assessing reduction in axial symptoms and inflammation.
Full Description
PsA is a chronic inflammatory musculoskeletal disease that has 6 disease domains, and axial disease represents one of the domains. Guselkumab is a fully human immunoglobulin (Ig) G1 lambda monoclonal antibody (mAb) that by binding to the p19 protein subunit of interleukin (IL)-23, blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-mediated intracellular signaling, activation, and cytokine production. This study will consist of a screening phase (up to 6 weeks), a treatment phase (up to 48 weeks, including a placebo-controlled period from Week 0 to Week 24 and an active-controlled treatment phase from Week 24 to Week 48), and a safety follow-up phase (up to Week 60). The efficacy assessments will include assessment such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and the safety assessments will include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events. The overall duration of the study will be up to 14 months.
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of psoriatic arthritis (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
Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender joints at screening and at baseline and b) C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram/deciliter (mg/dL) at screening from the central laboratory, and despite previous non-biologic disease modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine and/or sacroiliac [SI] joints, shown by a Spondyloarthritis Research Consortium of Canada [SPARCC] score of >= 3 in either the spine or the sacroiliac joints)
Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale [VAS]) of at least 4
Have active plaque psoriasis, with at least 1 psoriatic plaque of >= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
Exclusion Criteria:
Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS)/non-radiographic-axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
Has previously received any biologic treatment
Has ever received a 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
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There are 181 Locations for this study
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
Danbury Connecticut, 06810, United States
Bay Pines Florida, 33744, United States
Plantation Florida, 33324, United States
Zephyrhills Florida, 33542, United States
Chicago Illinois, 60640, United States
Hinsdale Illinois, 60521, United States
Rockford Illinois, 61114, United States
Hagerstown Maryland, 21740, United States
Saint Clair Shores Michigan, 48081, United States
Eagan Minnesota, 55121, United States
Springfield Missouri, 65807, United States
Vandalia Ohio, 45377, United States
Portland Oregon, 97239, United States
Austin Texas, 78731, United States
Colleyville Texas, 76034, United States
Corpus Christi Texas, 78404, United States
Houston Texas, 77030, United States
Lubbock Texas, 79424, United States
Mesquite Texas, 75150, United States
Red Oak Texas, 75154, United States
Tomball Texas, 77375, United States
Seattle Washington, 98122, United States
Buenos Aires , 1428, Argentina
Buenos Aires , C1199, Argentina
Buenos Aires , C1417, Argentina
La Plata , B1900, Argentina
Camberwell , 3124, Australia
Hobart , 7000, Australia
Liverpool , 2170, Australia
Maroochydore , 4558, Australia
Melbourne , 3053, Australia
Melbourne , 3128, Australia
Pleven , 5803, Bulgaria
Pleven , 5804, Bulgaria
Plovdiv , 4001, Bulgaria
Plovdiv , 4001, Bulgaria
Sfia , 1612, Bulgaria
Sofia , 1336, Bulgaria
Sofia , 1336, Bulgaria
Sofia , 1606, Bulgaria
Sofia , 1750, Bulgaria
Sofia , 1794, Bulgaria
Targovishte , 7700, Bulgaria
Vancouver British Columbia, V5Z 4, Canada
St. John's Newfoundland and Labrador, A1C 5, Canada
Toronto Ontario, M5T 2, Canada
Quebec , G1V 3, Canada
Brno - Zidenice , 615 0, Czechia
Brno , 61141, Czechia
Brno , 63800, Czechia
Hlucin , 748 0, Czechia
Ostrava , 70800, Czechia
Pardubice , 53002, Czechia
Praha , 128 0, Czechia
Uherske Hradiste , 68601, Czechia
Frederiksberg , 2000, Denmark
Glostrup , 2600, Denmark
Køge , 4600, Denmark
Vejle , 7100, Denmark
Berlin , 10789, Germany
Hamburg , 20095, Germany
Herne , 44649, Germany
Ratingen , 40878, Germany
Hong Kong , , Hong Kong
Budapest , 1023, Hungary
Budapest , H-103, Hungary
Gyula , 5700, Hungary
Kistarcsa , 2143, Hungary
Székesfehérvár , 8000, Hungary
Veszprem , 8200, Hungary
Haifa , 31048, Israel
Hifa , 34362, Israel
Kfar-Sava , 44281, Israel
Ramat Gan , 52656, Israel
Ancona , 60126, Italy
Reggio Emilia , 42123, Italy
Roma , 00133, Italy
Rozzano (MI) , 20089, Italy
Batu Caves , 68100, Malaysia
George Town , 10990, Malaysia
Johor Bahru , 81100, Malaysia
Kuala Lumpur , 59100, Malaysia
Seremban , 70300, Malaysia
Bialystok , 15-87, Poland
Bydgoszcz , 85-16, Poland
Bytom , 41-90, Poland
Elblag , 82-30, Poland
Elblag , 82-30, Poland
Krakow , 30-00, Poland
Krakow , 31-51, Poland
Lodz , 90-26, Poland
Lodz , 90-33, Poland
Lodz , 91-36, Poland
Lublin , 20-41, Poland
Nadarzyn , 05-83, Poland
Nowa Sol , 67-10, Poland
Poznan , 60-44, Poland
Swidnik , 21-04, Poland
Torun , 87-10, Poland
Warsaw , 00-87, Poland
Warszawa , 02-11, Poland
Warszawa , 02-66, Poland
Warszawa , 02-79, Poland
Warszawa , 03-29, Poland
Wrocław , 51-68, Poland
Braga , 4710-, Portugal
Guarda , 6300-, Portugal
Lisboa , 1050-, Portugal
Lisboa , 1349-, Portugal
Lisboa , 1350-, Portugal
Lisboa , 1649-, Portugal
Ponte de Lima , 4990-, Portugal
Porto , 4200-, Portugal
Barnaul , 65603, Russian Federation
Chelyabinsk , 45407, Russian Federation
Chelyabinsk , 45409, Russian Federation
Ekaterinbourg , 62010, Russian Federation
Izhevsk , 42600, Russian Federation
Kemerovo , 65007, Russian Federation
Korolev , 14106, Russian Federation
Krasnoyarsk , 66012, Russian Federation
Moscow , 11541, Russian Federation
Moscow , 11552, Russian Federation
Moscow , 12911, Russian Federation
Omsk , 64402, Russian Federation
Orenburg , 46000, Russian Federation
Perm , 61499, Russian Federation
Petrozavodsk , 18501, Russian Federation
Rostov , 34400, Russian Federation
St. Petersburg , 19006, Russian Federation
St. Petersburg , 19415, Russian Federation
Tolyatti , 44584, Russian Federation
Ufa , 45000, Russian Federation
Yaroslavl , 15000, Russian Federation
A Coruña , 15006, Spain
Barakaldo , 48902, Spain
Barcelona , 08036, Spain
Bilbao , 48013, Spain
Córdoba , 14004, Spain
Madrid , 28040, Spain
Málaga , 29009, Spain
Sabadell , 8208, Spain
Santiago de Compostela , 15702, Spain
Sevilla , 41009, Spain
Sevilla , 41013, Spain
Valencia , 46026, Spain
Solna , 171 7, Sweden
Hsin Chu , 30059, Taiwan
Tainan , 704, Taiwan
Taoyuan , 33305, Taiwan
Bangkok , 10400, Thailand
Bangkok , 10400, Thailand
Chiangmai , 50200, Thailand
Ankara , 06010, Turkey
Ankara , 06800, Turkey
Ankara , 6100, Turkey
Antalya , 7059, Turkey
Bursa , 16059, Turkey
Istanbul , 34098, Turkey
Istanbul , 34899, Turkey
Konya , 42080, Turkey
Cherkasy , 18009, Ukraine
Kharkiv , 61204, Ukraine
Khmelnytsky , 29000, Ukraine
Kryvyi Rih , 50056, Ukraine
Kyiv , 02081, Ukraine
Kyiv , 03049, Ukraine
Kyiv , 03680, Ukraine
Lutsk , 43005, Ukraine
Odessa , 65025, Ukraine
Poltava , 36011, Ukraine
Ternopil , 46002, Ukraine
Vinnytsia , 21009, Ukraine
Zaporizhzhya , 69600, Ukraine
Barnet , EN5 3, United Kingdom
Bradford , BD5 0, United Kingdom
Leeds , LS7 4, United Kingdom
Newcastle , NE29 , United Kingdom
Stoke on Trent , ST6 7, United Kingdom
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