Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent (SOLSTICE)

Last Updated   April 24, 2024 - 21:02

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 3
    The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Sites
    169 sites
  • Status
    Recruiting

SUMMARY

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.

CONDITIONS

  • Arthritis, Psoriatic

ELIGIBILITY

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

DETAILS

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.

LOCATIONS

Locations in:
United States, Ukraine, Turkey, Spain, Russia, Puerto Rico, Poland, Malaysia, Israel, Hungary, Czechia, Bulgaria, Australia, Argentina
Country (14) City or Province (169) Status
United States Albuquerque, NM Albuquerque Center for Rheumatology
RECRUITING
United States Baltimore, MD Johns Hopkins University
RECRUITING
United States Bay Pines, FL Bay Pines VA Healthcare System
RECRUITING
United States Beckley, WV Rheumatology and Pulmonary Clinic
RECRUITING
United States Birmingham, AL Rheumatology Associates
COMPLETED
United States Charlotte, NC DJL Clinical Research, PLLC
RECRUITING
United States Chicago, IL Great Lakes Clinical Trials
COMPLETED
United States Clearwater, FL Clinical Research of West Florida
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 Dallas, TX Metroplex Clinical Research Center
COMPLETED
United States Danbury, CT Clinical Research Center of Connecticut
COMPLETED
United States DeBary, FL Omega Research Consultants
RECRUITING
United States Eagan, MN St. Paul Rhuematology P A
RECRUITING
United States Flagstaff, AZ Arizona Arthritis and Rheumatology Research PLLC
RECRUITING
United States Fort Worth, TX Precision Comprehensive Clinical Research Solutions
COMPLETED
United States Hagerstown, MD Klein And Associates M D P A
RECRUITING
United States Huntington Beach, CA Newport Huntington Medical Group
RECRUITING
United States Lansing, MI Great Lakes Center of Rheumatology
RECRUITING
United States Las Cruces, NM Arthritis and Osteoperosis Associates of New Mexico
COMPLETED
United States Lubbock, TX West Texas Clinical Research
RECRUITING
United States Memphis, TN Dr. Ramesh Gupta
RECRUITING
United States Mesa, AZ Arizona Arthritis and Rheumatology Research PLLC
COMPLETED
United States Mesquite, TX Southwest Rheumatology Research LLC
COMPLETED
United States Monroe, LA The Arthritis and Diabetes Clinic
RECRUITING
United States Ocoee, FL Advanced Clinical Research of Orlando
RECRUITING
United States Okemos, MI Arthritis and Rheumatology Center of MI
RECRUITING
United States Oklahoma City, OK Health Research of Oklahoma
COMPLETED
United States Oklahoma City, OK Rheumatology Associates of Oklahoma
RECRUITING
United States Orchard Park, NY Buffalo Rheumatology and Medicine PLLC
RECRUITING
United States Phoenix, AZ Arizona Arthritis and Rheumatology Research PLLC
RECRUITING
United States Phoenix, AZ Arizona Arthritis and Rheumatology Research PLLC
RECRUITING
United States Plano, TX Texas Rheumatology Care
RECRUITING
United States Plantation, FL Integral Rheumatology And Immunology Specialists
RECRUITING
United States Saint Clair Shores, MI Clinical Research Institute of Michigan, LLC
COMPLETED
United States Saint Louis, MO Arthritis Consultants
COMPLETED
United States Searcy, AR Unity Health-White County Medical Center
COMPLETED
United States Skokie, IL Clinic of Robert Hozman
RECRUITING
United States Spokane, WA Arthritis Northwest PLLC
COMPLETED
United States Sun City, AZ Arizona Arthritis and Rheumatology Associates
RECRUITING
United States Tampa, FL Clinical Research of West Florida
RECRUITING
United States The Woodlands, TX Advanced Rheumatology of Houston
RECRUITING
United States Thousand Oaks, CA Medvin Clinical Research
COMPLETED
United States Tomball, TX DM Clinical Research
RECRUITING
United States Tucson, AZ Southern Arizona VA Healthcare System
RECRUITING
United States Tujunga, CA Medvin Clinical Research
RECRUITING
United States Vandalia, OH STAT Research, Inc.
COMPLETED
United States Voorhees, NJ Arthritis Rheumatic And Back Disease Associates
RECRUITING
United States Waco, TX Arthritis & Osteoporosis Clinic
RECRUITING
United States Zephyrhills, FL Florida Medical Clinic, P.A.
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
COMPLETED
Ukraine Kryvyi Rih City Clinical Hospital No. 2
TERMINATED
Ukraine Kyiv Kyiv City Clinical Hospital #3
COMPLETED
Ukraine Kyiv Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
COMPLETED
Ukraine Kyiv Medical Center 'Consylium Medical'
COMPLETED
Ukraine Kyiv Medical Center LLC 'Harmony of Beauty'
TERMINATED
Ukraine Kyiv Medical Center of 'Institute of Rheumatology', LLC
COMPLETED
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 LLC Medical House
TERMINATED
Ukraine Poltava ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
SUSPENDED
Ukraine Vinnytsya Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
TERMINATED
Ukraine Zaporizhzhya Medical Center LLC 'Modern Clinic'
SUSPENDED
Turkey Adana Adana City Hospital
RECRUITING
Turkey Ankara Ankara Bilkent City Hospital
RECRUITING
Turkey Ankara Gulhane Training and Research Hospital
RECRUITING
Turkey Ankara Hacettepe University Medical Faculty
RECRUITING
Turkey Antalya Akdeniz University Medical Faculty
RECRUITING
Turkey Bursa Uludag University Medical Faculty
RECRUITING
Turkey Denizli Pamukkale University Medical Faculty
RECRUITING
Turkey Eskisehir Osmangazi University Medical Faculty
COMPLETED
Turkey Istanbul Istanbul University Cerrahpasa Medical Faculty
COMPLETED
Turkey Istanbul Istanbul University Istanbul Medical Faculty
COMPLETED
Turkey Istanbul Kartal Dr Lutfi Kirdar sehir Hastanesi
RECRUITING
Turkey Istanbul Marmara University Medical Faculty
RECRUITING
Turkey Kocaeli Kocaeli University Medical Faculty
COMPLETED
Turkey Konya Necmettin Erbakan University Meram Medical Faculty
RECRUITING
Spain Barakaldo Hosp. Univ. de Cruces
RECRUITING
Spain Madrid, MD Hosp. Quiron Madrid Pozuelo
RECRUITING
Spain Madrid, MD Hosp. Univ. de La Princesa
RECRUITING
Spain Málaga Hosp. Regional Univ. de Malaga
RECRUITING
Spain Santiago de Compostela Clinica Gaias
RECRUITING
Spain Sevilla Hosp. Quiron Sagrado Corazon
RECRUITING
Spain Valencia, VC Hosp. Clinico Univ. de Valencia
RECRUITING
Russia Barnaul Altay Medical State University
SUSPENDED
Russia Chelyabinsk Chelyabinck Regional Clinical Hospital
TERMINATED
Russia Chelyabinsk Chelyabinsk Regional Clinical Dermatovenerological Dispensary
SUSPENDED
Russia Kemerovo Kemerovo State Medical University
SUSPENDED
Russia Kemerovo LLL Medical Center Revma-Med
SUSPENDED
Russia Korolev LLC Family Outpatient Clinic # 4
COMPLETED
Russia Krasnodar Krasnodar Clinical Dermatovenerologic Dispensary
SUSPENDED
Russia Krasnoyarsk Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
TERMINATED
Russia Moscow Clinical-Diagnostic Center Euromedservice, JSC
TERMINATED
Russia Moscow FGBU Research Institute of Rheumatology named V.A.Nasonova
TERMINATED
Russia Moscow GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
SUSPENDED
Russia Orenburg GBOU VPO Orenburg State Medical University
TERMINATED
Russia Rostov Rostov Regional Clinical Dermatovenerological Dispensary
SUSPENDED
Russia Saratov Saratov Regional Clinical Hospital
TERMINATED
Russia Smolensk Smolensk regional hospital on Smolensk railway station
TERMINATED
Russia St. Petersburg St. Petersburg GBUZ Clinical Reumatological Hospital 25
TERMINATED
Russia St. Petersburg X7 Clinical Research Company Limited
TERMINATED
Russia Tolyatti GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
TERMINATED
Russia Tula Tula Regional Clinical Dermatovenerological Dispensary
TERMINATED
Russia Ufa Republican Clinical Hospital - G.G. Kuvatov
COMPLETED
Puerto Rico San Juan FDI Clinical Research
RECRUITING
Puerto Rico San Juan GCM Medical Group
RECRUITING
Puerto Rico San Juan Mindful Medical Research
RECRUITING
Poland Bytom Nzoz Bif Med
COMPLETED
Poland Elblag Centrum Kliniczno Badawcze
RECRUITING
Poland Krakow Centrum Medyczne Promed
COMPLETED
Poland Krakow Malopolskie Badania Kliniczne Sp z o o
RECRUITING
Poland Krakow Malopolskie Centrum Kliniczne
RECRUITING
Poland Lodz Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
RECRUITING
Poland Lodz Dermed Centrum Medyczne 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 Centrum Medyczne
RECRUITING
Poland Poznan Twoja Przychodnia
RECRUITING
Poland Swidnik Lubelskie Centrum Diagnostyczne
COMPLETED
Poland Warsaw MICS Centrum Medyczne Warszawa
RECRUITING
Poland Warszawa Centrum Medyczne Reuma Park
RECRUITING
Poland Warszawa Rheuma-Medicus, Zaklad Opieki Zdrowotnej
RECRUITING
Poland Wrocław WroMedica I.Bielicka, A.Strzałkowska s.c.
RECRUITING
Malaysia Batu Caves, SL Hospital Selayang
COMPLETED
Malaysia George Town Hospital Pulau Pinang
COMPLETED
Malaysia Ipoh, PK Hospital Raja Permaisuri Bainun
RECRUITING
Malaysia Seremban, NS Hospital Tuanku Jaafar
COMPLETED
Israel Haifa, H Bnai Zion Medical Center
RECRUITING
Israel Haifa, H Rambam Health Care Campus
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 Uno Medical Trials Ltd.
RECRUITING
Hungary Debrecen Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház
COMPLETED
Hungary Gyula Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
RECRUITING
Hungary Kistarcsa Pest Megyei Flor Ferenc Korhaz
RECRUITING
Hungary Szeged Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
RECRUITING
Hungary Szekesfehervar Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
RECRUITING
Hungary Veszprem Vital Medical Center Orvosi es Fogaszati Kozpont
RECRUITING
Czechia Breclav RHEUMA 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 2 Revmatologicky ustav
RECRUITING
Czechia Uherske Hradiste Medical Plus S R O
RECRUITING
Czechia Zlin PV Medical S R O
COMPLETED
Bulgaria Pleven UMHAT 'Dr. Georgi Stranski', EAD
RECRUITING
Bulgaria Plovdiv Medical Center Unimed Plovdiv
RECRUITING
Bulgaria Plovdiv UMHAT Kaspela
RECRUITING
Bulgaria Ruse, 18 Diagnosis-consulting centre-1
RECRUITING
Bulgaria Sfia UMHAT St. Ivan Rilski
RECRUITING
Bulgaria Sofia ASIMP Rheumatology Centre St Irina EOOD
RECRUITING
Bulgaria Sofia Medical Centre Synexus
COMPLETED
Bulgaria Sofia Military Medical Academy
COMPLETED
Bulgaria Sofia University Multiprofile Hospital Sofiamed Sofia
COMPLETED
Australia Hobart, TAS Southern Clinical Research
TERMINATED
Australia Liverpool, NSW Liverpool Hospital
TERMINATED
Australia Melbourne, VIC Eastern Health - Box Hill Hospital
TERMINATED
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 Central Militar Cirujano Mayor Dr Cosme Argerich
RECRUITING
Argentina Ciudad Autonoma de Buenos Aires, B CIPREC
RECRUITING
Argentina Ciudad Autónoma de Buenos Aires, B OMI
RECRUITING
Argentina Ciudad de Mendoza Instituto de Reumatología Mendoza
RECRUITING
Argentina San Miguel De Tucuman Centro de Investigaciones Medicas Tucuman
RECRUITING
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