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.

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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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

405

Study ID:

NCT04929210

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 212 Locations for this study

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Arizona Arthritis & Rheumatology Research, PLLC
Chandler Arizona, 85225, United States
Arizona Arthritis and Rheumatology Research PLLC
Mesa Arizona, 85210, United States
Arizona Arthritis Research, PLC.
Phoenix Arizona, 85032, United States
Arizona Arthritis and Rheumatology Research PLLC
Phoenix Arizona, 85037, United States
Arizona Arthritis and Rheumatology Associates
Sun City Arizona, 85351, United States
Southern Arizona VA Healthcare System
Tucson Arizona, 85723, United States
Unity Health-White County Medical Center
Searcy Arkansas, 72143, United States
Newport Huntington Medical Group
Huntington Beach California, 92648, United States
Clinical Research Center of Connecticut
Danbury Connecticut, 06810, United States
Bay Pines VA Healthcare System
Bay Pines Florida, 33744, United States
Integral Rheumatology And Immunology Specialists
Plantation Florida, 33324, United States
Florida Medical Clinic, P.A.
Zephyrhills Florida, 33542, United States
Great Lakes Clinical Trials
Chicago Illinois, 60640, United States
RC Research
Hinsdale Illinois, 60521, United States
OrthoIllinois
Rockford Illinois, 61114, United States
Klein And Associates M D P A
Hagerstown Maryland, 21740, United States
Clinical Research Institute of Michigan, LLC
Saint Clair Shores Michigan, 48081, United States
St. Paul Rhuematology P A
Eagan Minnesota, 55121, United States
Clinvest
Springfield Missouri, 65807, United States
STAT Research, Inc.
Vandalia Ohio, 45377, United States
OHSU Rheumatology Clinic, Marquam Hill
Portland Oregon, 97239, United States
Amarillo Center for Clinical Research
Amarillo Texas, 79124, United States
Austin Regional Clinic
Austin Texas, 78731, United States
Precision Comprehensive Clinical Research Solutions
Colleyville Texas, 76034, United States
Adriana Pop Moody MD Clinic PA
Corpus Christi Texas, 78404, United States
UT Physicians Center for Autoimmunity
Houston Texas, 77030, United States
West Texas Clinical Research
Lubbock Texas, 79424, United States
Southwest Rheumatology Research LLC
Mesquite Texas, 75150, United States
Epic Medical Research
Red Oak Texas, 75154, United States
DM Clinical Research
Tomball Texas, 77375, United States
Swedish Medical Center
Seattle Washington, 98122, United States
Cosultorios Reumatologógicos Pampa
Buenos Aires , 1428, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires , C1199, Argentina
Centro Privado de Medicina Familiar
Buenos Aires , C1417, Argentina
Hospital Italiano La Plata
La Plata , B1900, Argentina
Emeritus Research
Camberwell , 3124, Australia
Southern Clinical Research
Hobart , 7000, Australia
Liverpool Hospital
Liverpool , 2170, Australia
Rheumatology Research Unit
Maroochydore , 4558, Australia
Skin Health Institute Inc.
Melbourne , 3053, Australia
Eastern Health - Box Hill Hospital
Melbourne , 3128, Australia
Exacta Medica
Pleven , 5803, Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
Pleven , 5804, Bulgaria
Medical Center Unimed Plovdiv
Plovdiv , 4001, Bulgaria
UMHAT Kaspela
Plovdiv , 4001, Bulgaria
Medical Center Artmed
Plovdiv , 4002, Bulgaria
UMHAT St. Ivan Rilski
Sfia , 1612, Bulgaria
MHAT 'Lyulin' EAD
Sofia , 1336, Bulgaria
University Multiprofile Hospital Sofiamed Sofia
Sofia , 1336, Bulgaria
Military Medical Academy
Sofia , 1606, Bulgaria
DCC Convex EOOD
Sofia , 1680, Bulgaria
ASIMP Rheumatology Centre St Irina EOOD
Sofia , 1750, Bulgaria
Medical Centre Synexus
Sofia , 1794, Bulgaria
DDC Sv. Ivan Rilski OOD
Targovishte , 7700, Bulgaria
Skin Care Centre
Vancouver British Columbia, V5Z 4, Canada
Eastern Regional Health Authority, St. Clare's Mercy Hospital
St. John's Newfoundland and Labrador, A1C 5, Canada
Toronto Western Hospital
Toronto Ontario, M5T 2, Canada
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Quebec , G1V 3, Canada
Revmacentrum MUDr Mostera s r o
Brno Zidenice , 615 0, Czechia
Revmaclinic
Brno , 61141, Czechia
Revmatologie s r o
Brno , 63800, Czechia
L K N Arthrocentrum
Hlucin , 748 0, Czechia
MUDr Rosypalova s r o
Ostrava , 70800, Czechia
Arthrohelp S.R.O.
Pardubice , 53002, Czechia
Revmatologicky ustav
Praha , 128 0, Czechia
Medical Plus S R O
Uherske Hradiste , 68601, Czechia
Frederiksberg Hospital
Frederiksberg , 2000, Denmark
Rigshospitalet Glostrup
Glostrup , 2600, Denmark
Køge Sygehus Region Sjaelland
Køge , 4600, Denmark
Vejle Sygehus
Vejle , 7100, Denmark
LTD Clinic LJ
Kutaisi , 4600, Georgia
Ltd American Hospital Network
T'bilisi , 0102, Georgia
Tbilisi Heart and Vascular Clinic Ltd
T'bilisi , 0159, Georgia
LTD 'Aversi Clinic'
T'bilisi , 0160, Georgia
Clinic on Mtskheta Street
T'bilisi , 0179, Georgia
Aleksandre Aladashvili Clinic LLC
Tbilisi , 0102, Georgia
LTD Helsicore
Tbilisi , 0112, Georgia
Ltd New Hospitals
Tbilisi , 0114, Georgia
TSMU The First University Clinic
Tbilisi , 0141, Georgia
LTD MediClub Georgia
Tbilisi , 0160, Georgia
LTD The First Medical Center
Tbilisi , 0180, Georgia
Consilium Medulla-multiprofile clinic Ltd
Tbilisi , 0186, Georgia
JSC Evex Hospitals
Tnilisi , 0159, Georgia
ISA - Interdisciplinary Study Association GmbH
Berlin , 10789, Germany
Hamburger Rheuma Forschungszentrum II
Hamburg , 20095, Germany
Rheumazentrum Ruhrgebiet
Herne , 44649, Germany
Rheumazentrum Ratingen
Ratingen , 40878, Germany
Prince Of Wales Hospital
Hong Kong , , Hong Kong
Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz
Budapest , 1023, Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest , 1036, Hungary
Qualiclinic Kft
Budapest , H-103, Hungary
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula , 5700, Hungary
Kistarcsai Flor Ferenc Korhaz
Kistarcsa , 2143, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
Székesfehérvár , 8000, Hungary
Vital Medical Center Orvosi es Fogaszati Kozpont
Veszprem , 8200, Hungary
Bnai Zion Medical Center
Haifa , 31048, Israel
Carmel Medical Center
Hifa , 34362, Israel
Meir Medical Center
Kfar-Sava , 44281, Israel
Sheba Medical Center
Ramat Gan , 52656, Israel
A.O. Universitaria Ospedali Riuniti di Ancona
Ancona , 60126, Italy
Azienda Ospedaliero-Universitaria di Cagliari
Monserrato , 09124, Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia , 42123, Italy
Policlinico Tor Vergata
Roma , 00133, Italy
Humanitas Hospital
Rozzano (MI) , 20089, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona , 37126, Italy
Hospital Selayang
Batu Caves , 68100, Malaysia
Hospital Pulau Pinang
George Town , 10990, Malaysia
Hospital Sultan Ismail
Johor Bahru , 81100, Malaysia
University Malaya Medical Centre
Kuala Lumpur , 59100, Malaysia
Hospital Tuanku Jaafar
Seremban , 70300, Malaysia
Cebu Doctors' University Hospital
Cebu City , 6000, Philippines
Davao Doctors Hospital
Davao City , 8000, Philippines
Lipa Medix Medical Hospital
Lipa , 4217, Philippines
ManilaMed Medical Center Manila
Manila , 1000, Philippines
Ilocos Training and Regional Medical Center
San Fernando , 2500, Philippines
ClinicMed Daniluk Nowak Spolka Komandytowa
Bialystok , 15 87, Poland
Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
Bydgoszcz , 85-16, Poland
Nzoz Bif Med
Bytom , 41-90, Poland
Ambulatorium sp. z o.o.
Elblag , 82 30, Poland
Centrum Kliniczno Badawcze
Elblag , 82-30, Poland
Malopolskie Badania Kliniczne Sp z o o
Krakow , 30 00, Poland
Centrum Medyczne Promed
Krakow , 31-51, Poland
Dermed Centrum Medyczne Sp z o o
Lodz , 90 26, Poland
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz , 90-33, Poland
Centrum Medyczne AMED oddzial w Lodzi
Lodz , 91-36, Poland
KO-MED Centra Kliniczne LUBLIN
Lublin , 20-36, Poland
Pro Life Medica Sp. z o.o.
Lublin , 20-41, Poland
NZOZ Lecznica MAK MED S C
Nadarzyn , 05 83, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sol , 67-10, Poland
Reumedika s c Wieslawa Porawska Lukasz Porawski
Poznan , 60-44, Poland
Twoja Przychodnia Poznanskie Centrum Medyczne
Poznan , 61-29, Poland
Lubelskie Centrum Diagnostyczne
Swidnik , 21-04, Poland
MICS Centrum Medyczne Torun
Torun , 87-10, Poland
MICS Centrum Medyczne Warszawa
Warsaw , 00-87, Poland
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw , 02 63, Poland
Rheuma-Medicus Sp. z o.o.
Warszawa , 02-11, Poland
Centrum Medyczne Reuma Park
Warszawa , 02-66, Poland
ETG Warszawa
Warszawa , 02-79, Poland
Centrum Medyczne AMED Targowek
Warszawa , 03-29, Poland
WroMedica I.Bielicka, A.Strzałkowska s.c.
Wrocław , 51-68, Poland
Ccab - Hosp. de Braga
Braga , 4710-, Portugal
Ulsg - Hosp. Sousa Martins
Guarda , 6300-, Portugal
Ipr - Inst. Port. de Reumatologia
Lisboa , 1050 , Portugal
Chlo - Hosp. Egas Moniz
Lisboa , 1349-, Portugal
Hospital CUF Tejo
Lisboa , 1350-, Portugal
Chln - Hosp. Santa Maria
Lisboa , 1649-, Portugal
Ulsam - Hosp. Conde de Bertiandos
Ponte de Lima , 4990-, Portugal
Chsj - Hosp. Sao Joao
Porto , 4200-, Portugal
Altay Medical State University
Barnaul , 65603, Russian Federation
Chelyabinck Regional Clinical Hospital
Chelyabinsk , 45407, Russian Federation
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Chelyabinsk , 45409, Russian Federation
Sverdlovsk Regional Clinical Hospital N. 1
Ekaterinbourg , 62010, Russian Federation
Regional Clinical Diagnostic Center of Udmurtia Region
Izhevsk , 42600, Russian Federation
LLL Medical Center Revma-Med
Kemerovo , 65007, Russian Federation
LLC Family Outpatient Clinic # 4
Korolev , 14106, Russian Federation
Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
Krasnoyarsk , 66012, Russian Federation
Clinical-Diagnostic Center Euromedservice, JSC
Moscow , 11541, Russian Federation
FGBU Research Institute of Rheumatology named V.A.Nasonova
Moscow , 11552, Russian Federation
GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
Moscow , 12911, Russian Federation
Llc Ultramed
Omsk , 64402, Russian Federation
GBOU VPO Orenburg State Medical University
Orenburg , 46000, Russian Federation
GBUZ Perm Regional Clinical Hospital
Perm , 61499, Russian Federation
Republican Hospital n.a.V.A.Baranov
Petrozavodsk , 18501, Russian Federation
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov , 34400, Russian Federation
St. Petersburg GBUZ Clinical Reumatological Hospital 25
St. Petersburg , 19006, Russian Federation
X7 Clinical Research Company Limited
St. Petersburg , 19415, Russian Federation
GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
Tolyatti , 44584, Russian Federation
Republican Clinical Hospital - G.G. Kuvatov
Ufa , 45000, Russian Federation
Clinical Hospital #3
Yaroslavl , 15000, Russian Federation
Reumatologicka ambulancia
Martin , 036 0, Slovakia
Reumatologicka ambulancia
Nove Mesto nad Vahom , 91501, Slovakia
Reumatologická ambulancia Thermium s.r.o.
Piestany , 921 0, Slovakia
REUMAMED POPRAD, s.r.o.
Poprad , 05801, Slovakia
Reumex s.r.o
Rimavska Sobota , , Slovakia
Hosp. Univ. A Coruna
A Coruna , 15006, Spain
Hosp. Univ. de Cruces
Barakaldo , 48902, Spain
Hosp. Clinic de Barcelona
Barcelona , 08036, Spain
Hosp. Univ. de Basurto
Bilbao , 48013, Spain
Hosp. Reina Sofia
Cordoba , 14004, Spain
Hosp. Clinico San Carlos
Madrid , 28040, Spain
Hosp. Regional Univ. de Malaga
Málaga , 29009, Spain
Corporacio Sanitari Parc Tauli
Sabadell , 8208, Spain
Clinica Gaias
Santiago de Compostela , 15702, Spain
Hosp. Virgen Macarena
Sevilla , 41009, Spain
Hosp. Quiron Sagrado Corazon
Sevilla , 41013, Spain
Hosp. Univ. I Politecni La Fe
Valencia , 46026, Spain
Karolinska Universitetssjukhuset
Solna , 171 7, Sweden
Akademiska Sjukhuset
Uppsala , 753 0, Sweden
National Taiwan University Hospital
Hsin Chu , 30059, Taiwan
National Cheng Kung University Hospital
Tainan , 704, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan , 33305, Taiwan
Phramongkutklao Hospital and Medical College
Bangkok , 10400, Thailand
Ramathibodi Hospital, Mahidol University
Bangkok , 10400, Thailand
Chiang Mai University
Chiangmai , 50200, Thailand
Adana City Hospital
Adana , 01370, Turkey
Gulhane Training and Research Hospital
Ankara , 06010, Turkey
Ankara Bilkent City Hospital
Ankara , 06800, Turkey
Hacettepe University Medical Faculty
Ankara , 6100, Turkey
Akdeniz University Medical Faculty
Antalya , 7059, Turkey
Uludag University Medical Faculty
Bursa , 16059, Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul , 34098, Turkey
Marmara University Medical Faculty
Istanbul , 34899, Turkey
Necmettin Erbakan University Meram Medical Faculty
Konya , 42080, Turkey
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy , 18009, Ukraine
Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
Kharkiv , 61204, Ukraine
Khmelnitckiy regional hospital
Khmelnytsky , 29000, Ukraine
City Clinical Hospital No. 2
Kryvyi Rih , 50056, Ukraine
Medical Center of 'Institute of Rheumatology', LLC
Kyiv , 02081, Ukraine
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
Kyiv , 03049, Ukraine
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
Kyiv , 03680, Ukraine
Volyn Regional Clinical Hospital
Lutsk , 43005, Ukraine
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
Odessa , 65025, Ukraine
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
Poltava , 36011, Ukraine
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Ternopil , 46002, Ukraine
Health Clinic Limited Liability Company
Vinnytsia , 21009, Ukraine
Medical Center LLC 'Modern Clinic'
Zaporizhzhya , 69600, Ukraine
Royal Free London NHS Foundation Trust
Barnet , EN5 3, United Kingdom
St. Lukes Hospital
Bradford , BD5 0, United Kingdom
University Hospital Coventry & Warwickshire NHS Trust
Coventry , CV2 2, United Kingdom
Chapel Allerton Hospital
Leeds , LS7 4, United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester , M13 9, United Kingdom
North Tyneside General Hospital
Newcastle , NE29 , United Kingdom
Haywood Hospital
Stoke on Trent , ST6 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

405

Study ID:

NCT04929210

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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