A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease (STAR)

Last Updated   April 24, 2024 - 21:02

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 4
    These studies are conducted after a drug or treatment is approved for use by regulatory authorities. Phase 4 studies gather additional information on the drug's effects and side effects.
  • Sites
    223 sites
  • Status
    Recruiting

SUMMARY

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.

CONDITIONS

  • Arthritis, Psoriatic

ELIGIBILITY

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

DETAILS

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.

LOCATIONS

Locations in:
United States, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Sweden, Spain, Slovakia, Russia, Portugal, Poland, Philippines, Malaysia, Italy, Israel, Hungary, Hong Kong, Germany, Georgia, Denmark, Czechia, Canada, Bulgaria, Australia, Argentina
Country (26) City or Province (223) Status
United States Amarillo, TX Amarillo Center for Clinical Research
RECRUITING
United States Austin, TX Austin Regional Clinic
COMPLETED
United States Bay Pines, FL Bay Pines VA Healthcare System
RECRUITING
United States Chandler, AZ Arizona Arthritis & Rheumatology Research, PLLC
RECRUITING
United States Chicago, IL Great Lakes Clinical Trials
RECRUITING
United States Colleyville, TX Precision Comprehensive Clinical Research Solutions
RECRUITING
United States Corpus Christi, TX Adriana Pop Moody MD Clinic PA
COMPLETED
United States Danbury, CT Clinical Research Center of Connecticut
COMPLETED
United States Eagan, MN St. Paul Rhuematology P A
RECRUITING
United States Hagerstown, MD Klein And Associates M D P A
COMPLETED
United States Hinsdale, IL RC Research
RECRUITING
United States Houston, TX UT Physicians Center for Autoimmunity
RECRUITING
United States Huntington Beach, CA Newport Huntington Medical Group
RECRUITING
United States Lubbock, TX West Texas Clinical Research
RECRUITING
United States Mesa, AZ Arizona Arthritis and Rheumatology Research PLLC
RECRUITING
United States Mesquite, TX Southwest Rheumatology Research LLC
COMPLETED
United States Phoenix, AZ Arizona Arthritis Research, PLC.
RECRUITING
United States Phoenix, AZ Arizona Arthritis and Rheumatology Research PLLC
RECRUITING
United States Plantation, FL Integral Rheumatology And Immunology Specialists
RECRUITING
United States Portland, OR OHSU Rheumatology Clinic, Marquam Hill
RECRUITING
United States Red Oak, TX Epic Medical Research
RECRUITING
United States Rockford, IL OrthoIllinois
RECRUITING
United States Saint Clair Shores, MI Clinical Research Institute of Michigan, LLC
RECRUITING
United States Searcy, AR Unity Health-White County Medical Center
RECRUITING
United States Seattle, WA Swedish Medical Center
RECRUITING
United States Springfield, MO Clinvest
RECRUITING
United States Sun City, AZ Arizona Arthritis and Rheumatology Associates
RECRUITING
United States Tomball, TX DM Clinical Research
RECRUITING
United States Tucson, AZ Southern Arizona VA Healthcare System
RECRUITING
United States Vandalia, OH STAT Research, Inc.
COMPLETED
United States Zephyrhills, FL Florida Medical Clinic, P.A.
COMPLETED
United Kingdom Barnet Royal Free London NHS Foundation Trust
RECRUITING
United Kingdom Bradford, WYK St. Lukes Hospital
RECRUITING
United Kingdom Coventry, WMD University Hospital Coventry & Warwickshire NHS Trust
RECRUITING
United Kingdom Leeds, WYK Chapel Allerton Hospital
RECRUITING
United Kingdom Manchester Central Manchester University Hospitals NHS Foundation Trust
RECRUITING
United Kingdom Newcastle North Tyneside General Hospital
RECRUITING
United Kingdom Stoke on Trent Haywood Hospital
RECRUITING
Ukraine Cherkasy Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
TERMINATED
Ukraine Kharkiv Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
COMPLETED
Ukraine Khmelnytsky Khmelnitckiy regional hospital
TERMINATED
Ukraine Kryvyi Rih City Clinical Hospital No. 2
TERMINATED
Ukraine Kyiv Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
COMPLETED
Ukraine Kyiv Medical Center of 'Institute of Rheumatology', LLC
TERMINATED
Ukraine Kyiv SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
COMPLETED
Ukraine Lutsk Volyn Regional Clinical Hospital
COMPLETED
Ukraine Odessa Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
TERMINATED
Ukraine Poltava ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
TERMINATED
Ukraine Ternopil Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
COMPLETED
Ukraine Vinnytsia Health Clinic Limited Liability Company
TERMINATED
Ukraine Zaporizhzhya Medical Center LLC 'Modern Clinic'
TERMINATED
Turkey Adana Adana City Hospital
RECRUITING
Turkey Ankara Ankara Bilkent City Hospital
COMPLETED
Turkey Ankara Gulhane Training and Research Hospital
RECRUITING
Turkey Ankara Hacettepe University Medical Faculty
COMPLETED
Turkey Antalya Akdeniz University Medical Faculty
RECRUITING
Turkey Bursa Uludag University Medical Faculty
RECRUITING
Turkey Istanbul Istanbul University Cerrahpasa Medical Faculty
RECRUITING
Turkey Istanbul Marmara University Medical Faculty
RECRUITING
Turkey Konya Necmettin Erbakan University Meram Medical Faculty
RECRUITING
Thailand Bangkok, 10 Phramongkutklao Hospital and Medical College
RECRUITING
Thailand Bangkok, 10 Ramathibodi Hospital, Mahidol University
RECRUITING
Thailand Chiangmai, 50 Chiang Mai University
RECRUITING
Taiwan Hsin Chu National Taiwan University Hospital
RECRUITING
Taiwan Tainan National Cheng Kung University Hospital
RECRUITING
Taiwan Taoyuan Linkou Chang Gung Memorial Hospital
RECRUITING
Sweden Solna Karolinska Universitetssjukhuset
RECRUITING
Sweden Uppsala Akademiska Sjukhuset
RECRUITING
Spain A Coruna Hosp. Univ. A Coruna
RECRUITING
Spain Barakaldo Hosp. Univ. de Cruces
RECRUITING
Spain Barcelona, BA Hosp. Clinic de Barcelona
RECRUITING
Spain Bilbao Hosp. Univ. de Basurto
RECRUITING
Spain Cordoba Hosp. Reina Sofia
RECRUITING
Spain Madrid, MD Hosp. Clinico San Carlos
COMPLETED
Spain Málaga Hosp. Regional Univ. de Malaga
RECRUITING
Spain Sabadell, BA Corporacio Sanitari Parc Tauli
RECRUITING
Spain Santiago de Compostela Clinica Gaias
RECRUITING
Spain Sevilla Hosp. Quiron Sagrado Corazon
RECRUITING
Spain Sevilla Hosp. Virgen Macarena
RECRUITING
Spain Valencia, VC Hosp. Univ. I Politecni La Fe
RECRUITING
Slovakia Martin Reumatologicka ambulancia
RECRUITING
Slovakia Nove Mesto nad Vahom Reumatologicka ambulancia
RECRUITING
Slovakia Piestany Reumatologická ambulancia Thermium s.r.o.
RECRUITING
Slovakia Poprad REUMAMED POPRAD, s.r.o.
RECRUITING
Slovakia Rimavska Sobota Reumex s.r.o
RECRUITING
Russia Barnaul Altay Medical State University
COMPLETED
Russia Chelyabinsk Chelyabinck Regional Clinical Hospital
TERMINATED
Russia Chelyabinsk Chelyabinsk Regional Clinical Dermatovenerological Dispensary
COMPLETED
Russia Ekaterinbourg Sverdlovsk Regional Clinical Hospital N. 1
TERMINATED
Russia Izhevsk Regional Clinical Diagnostic Center of Udmurtia Region
COMPLETED
Russia Kemerovo LLL Medical Center Revma-Med
COMPLETED
Russia Korolev LLC Family Outpatient Clinic # 4
COMPLETED
Russia Krasnoyarsk Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
TERMINATED
Russia Moscow Clinical-Diagnostic Center Euromedservice, JSC
COMPLETED
Russia Moscow FGBU Research Institute of Rheumatology named V.A.Nasonova
COMPLETED
Russia Moscow GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
COMPLETED
Russia Omsk Llc Ultramed
COMPLETED
Russia Orenburg GBOU VPO Orenburg State Medical University
TERMINATED
Russia Perm GBUZ Perm Regional Clinical Hospital
TERMINATED
Russia Petrozavodsk Republican Hospital n.a.V.A.Baranov
COMPLETED
Russia Rostov Rostov Regional Clinical Dermatovenerological Dispensary
COMPLETED
Russia St. Petersburg St. Petersburg GBUZ Clinical Reumatological Hospital 25
COMPLETED
Russia St. Petersburg X7 Clinical Research Company Limited
TERMINATED
Russia Tolyatti GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
COMPLETED
Russia Ufa Republican Clinical Hospital - G.G. Kuvatov
COMPLETED
Russia Yaroslavl Clinical Hospital #3
COMPLETED
Portugal Braga, Braga Ccab - Hosp. de Braga
RECRUITING
Portugal Guarda Ulsg - Hosp. Sousa Martins
RECRUITING
Portugal Lisboa Chln - Hosp. Santa Maria
RECRUITING
Portugal Lisboa Chlo Hosp Egas Moniz
RECRUITING
Portugal Lisboa Hospital CUF Tejo
COMPLETED
Portugal Lisboa Ipr - Inst. Port. de Reumatologia
RECRUITING
Portugal Ponte de Lima Ulsam - Hosp. Conde de Bertiandos
RECRUITING
Portugal Porto Chsj - Hosp. Sao Joao
RECRUITING
Poland Bialystok ClinicMed Daniluk Nowak Spolka Komandytowa
RECRUITING
Poland Bydgoszcz Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
RECRUITING
Poland Bytom Nzoz Bif Med
RECRUITING
Poland Elblag Ambulatorium sp. z o.o.
RECRUITING
Poland Elblag Centrum Kliniczno Badawcze
RECRUITING
Poland Krakow Centrum Medyczne Promed
RECRUITING
Poland Krakow Malopolskie Badania Kliniczne Sp z o o
RECRUITING
Poland Lodz Centrum Medyczne AMED oddzial w Lodzi
RECRUITING
Poland Lodz Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
RECRUITING
Poland Lodz Dermed Centrum Medyczne Sp z o o
RECRUITING
Poland Lublin KO-MED Centra Kliniczne LUBLIN
RECRUITING
Poland Lublin Pro Life Medica Sp. z o.o.
RECRUITING
Poland Nadarzyn NZOZ Lecznica MAK MED S C
RECRUITING
Poland Nowa Sol Twoja Przychodnia - Centrum Medyczne Nowa Sol
RECRUITING
Poland Poznan Reumedika s c Wieslawa Porawska Lukasz Porawski
RECRUITING
Poland Poznan Twoja Przychodnia Poznanskie Centrum Medyczne
RECRUITING
Poland Swidnik Lubelskie Centrum Diagnostyczne
RECRUITING
Poland Torun MICS Centrum Medyczne Torun
RECRUITING
Poland Warsaw MICS Centrum Medyczne Warszawa
RECRUITING
Poland Warsaw Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
RECRUITING
Poland Warszawa Centrum Medyczne AMED Targowek
RECRUITING
Poland Warszawa Centrum Medyczne Reuma Park
RECRUITING
Poland Warszawa ETG Warszawa
COMPLETED
Poland Warszawa Rheuma-Medicus Sp. z o.o.
RECRUITING
Poland Wrocław WroMedica I.Bielicka, A.Strzałkowska s.c.
RECRUITING
Philippines Cebu City, CEB Cebu Doctors' University Hospital
RECRUITING
Philippines Davao City, DSU Davao Doctors Hospital
RECRUITING
Philippines Lipa, BTG Lipa Medix Medical Hospital
RECRUITING
Philippines Manila ManilaMed Medical Center Manila
RECRUITING
Philippines San Fernando, PMP Ilocos Training and Regional Medical Center
RECRUITING
Malaysia Batu Caves, SL Hospital Selayang
RECRUITING
Malaysia George Town Hospital Pulau Pinang
RECRUITING
Malaysia Johor Bahru, JH Hospital Sultan Ismail
RECRUITING
Malaysia Kuala Lumpur University Malaya Medical Centre
RECRUITING
Malaysia Seremban, NS Hospital Tuanku Jaafar
RECRUITING
Italy Ancona A.O. Universitaria Ospedali Riuniti di Ancona
RECRUITING
Italy Monserrato Azienda Ospedaliero-Universitaria di Cagliari
RECRUITING
Italy Reggio Emilia Arcispedale Santa Maria Nuova - IRCCS
RECRUITING
Italy Roma Policlinico Tor Vergata
RECRUITING
Italy Rozzano (MI) Humanitas Hospital
RECRUITING
Italy Verona Azienda Ospedaliera Universitaria Integrata Verona
RECRUITING
Israel Haifa, H Bnai Zion Medical Center
RECRUITING
Israel Hifa, H Carmel Medical Center
RECRUITING
Israel Kfar-Sava Meir Medical Center
COMPLETED
Israel Ramat Gan Sheba Medical Center
RECRUITING
Hungary Budapest Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz
RECRUITING
Hungary Budapest Obudai Egeszsegugyi Centrum Kft
RECRUITING
Hungary Budapest Qualiclinic Kft
RECRUITING
Hungary Gyula Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
RECRUITING
Hungary Kistarcsa Kistarcsai Flor Ferenc Korhaz
RECRUITING
Hungary Székesfehérvár Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
RECRUITING
Hungary Veszprem Vital Medical Center Orvosi es Fogaszati Kozpont
RECRUITING
Hong Kong Hong Kong Prince Of Wales Hospital
RECRUITING
Germany Berlin, BE ISA - Interdisciplinary Study Association GmbH
RECRUITING
Germany Hamburg, HH Hamburger Rheuma Forschungszentrum II
COMPLETED
Germany Herne, NW Rheumazentrum Ruhrgebiet
RECRUITING
Germany Ratingen Rheumazentrum Ratingen
COMPLETED
Georgia Kutaisi, IM LTD Clinic LJ
RECRUITING
Georgia T'bilisi, TB Clinic on Mtskheta Street
RECRUITING
Georgia T'bilisi, TB LTD 'Aversi Clinic'
RECRUITING
Georgia T'bilisi, TB Ltd American Hospital Network
RECRUITING
Georgia T'bilisi, TB Tbilisi Heart and Vascular Clinic Ltd
RECRUITING
Georgia Tbilisi, TB Aleksandre Aladashvili Clinic LLC
RECRUITING
Georgia Tbilisi, TB Consilium Medulla-multiprofile clinic Ltd
RECRUITING
Georgia Tbilisi, TB LTD Helsicore
RECRUITING
Georgia Tbilisi, TB LTD MediClub Georgia
RECRUITING
Georgia Tbilisi, TB LTD The First Medical Center
RECRUITING
Georgia Tbilisi, TB Ltd New Hospitals
RECRUITING
Georgia Tbilisi, TB TSMU The First University Clinic
RECRUITING
Georgia Tnilisi, TB JSC Evex Hospitals
RECRUITING
Denmark Frederiksberg Frederiksberg Hospital
RECRUITING
Denmark Glostrup Rigshospitalet Glostrup
RECRUITING
Denmark Køge Køge Sygehus Region Sjaelland
RECRUITING
Denmark Vejle Vejle Sygehus
RECRUITING
Czechia Brno Revmaclinic
COMPLETED
Czechia Brno Revmatologie s r o
COMPLETED
Czechia Brno Zidenice Revmacentrum MUDr Mostera s r o
RECRUITING
Czechia Hlucin L K N Arthrocentrum
RECRUITING
Czechia Ostrava MUDr Rosypalova s r o
RECRUITING
Czechia Pardubice Arthrohelp S.R.O.
RECRUITING
Czechia Praha Revmatologicky ustav
RECRUITING
Czechia Uherske Hradiste Medical Plus S R O
RECRUITING
Canada Quebec, QC G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
RECRUITING
Canada St. John's, NL Eastern Regional Health Authority, St. Clare's Mercy Hospital
RECRUITING
Canada Toronto, ON Toronto Western Hospital
RECRUITING
Canada Vancouver, BC Skin Care Centre
RECRUITING
Bulgaria Pleven Exacta Medica
RECRUITING
Bulgaria Pleven UMHAT 'Dr. Georgi Stranski', EAD
RECRUITING
Bulgaria Plovdiv Medical Center Artmed
RECRUITING
Bulgaria Plovdiv Medical Center Unimed Plovdiv
RECRUITING
Bulgaria Plovdiv UMHAT Kaspela
RECRUITING
Bulgaria Sfia UMHAT St. Ivan Rilski
RECRUITING
Bulgaria Sofia ASIMP Rheumatology Centre St Irina EOOD
RECRUITING
Bulgaria Sofia DCC Convex EOOD
RECRUITING
Bulgaria Sofia MHAT 'Lyulin' EAD
RECRUITING
Bulgaria Sofia Medical Centre Synexus
RECRUITING
Bulgaria Sofia Military Medical Academy
RECRUITING
Bulgaria Sofia University Multiprofile Hospital Sofiamed Sofia
COMPLETED
Bulgaria Targovishte DDC Sv. Ivan Rilski OOD
RECRUITING
Australia Camberwell, VIC Emeritus Research
COMPLETED
Australia Hobart, TAS Southern Clinical Research
RECRUITING
Australia Liverpool, NSW Liverpool Hospital
COMPLETED
Australia Maroochydore, QLD Rheumatology Research Unit
TERMINATED
Australia Melbourne, VIC Eastern Health - Box Hill Hospital
COMPLETED
Australia Melbourne, VIC Skin Health Institute Inc.
TERMINATED
Argentina Buenos Aires, B Centro Privado de Medicina Familiar
RECRUITING
Argentina Buenos Aires, B Cosultorios Reumatologógicos Pampa
RECRUITING
Argentina Buenos Aires, B Hospital Italiano de Buenos Aires
RECRUITING
Argentina La Plata Hospital Italiano La Plata
RECRUITING
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