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Nipocalimab nella malattia di Sjogren da moderata a grave (DAFFODIL)

2 novembre 2026 aggiornato da: Janssen Research & Development, LLC

Un protocollo di fase 3 randomizzato, controllato con placebo, in doppio cieco, multicentrico per valutare l'efficacia e la sicurezza di Nipocalimab negli adulti con malattia di Sjogren (SjD) da moderata a grave

The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This clinical development program for nipocalimab in SjD includes 2 identical double blind, placebo-controlled studies to evaluate the efficacy, safety, and tolerability of nipocalimab in participants greater than or equal to (>=) 18 years of age with moderate to severe SjD.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

655

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Argentina
      • Buenos Aires, Argentina, B1643CRO
        • Instituto Medico De Alta Complejidad (IMAC)
      • Buenos Aires, Argentina, B1663GJE
        • Centro de Investigacion San Miguel CISM
      • CABA, Argentina, C1128AAF
        • Mautalen Salud e Investigacion
      • Cdad Autonoma de Buenos Aires, Argentina, C1123AAO
        • Centro Medico del Dr. Javier Gerardo Tartaglione
      • Ciudad de Buenos Aires, Argentina, C1055
        • Centro de Investigacion en Enfermedades Reumaticas CIER
      • Ciudad de Buenos Aires, Argentina, C1414
        • Centro Medico Barrio Parque. Swiss Medical Group
      • Ciudad de Buenos Aires, Argentina, C1428
        • Cosultorios Reumatologógicos Pampa
      • Quilmes, Argentina, B1878DVB
        • Cer Instituto Medico
      • San Fernando, Argentina, B1646GHP
        • MR Medicina Reumatologica
      • San Miguel de Tucumán, Argentina, T4000AXL
        • Centro de Investigaciones Medicas Tucuman
  • Austria
      • Graz, Austria, 8036
        • Medizinische Universitaet Graz
      • Salzburg, Austria, 5020
        • SCRI CCCIT gem GmbH
      • Stockerau, Austria, 2000
        • LK Weinviertel Stockerau
      • Vienna, Austria, 1090
        • Medizinische Universitaet Wien
      • Vienna, Austria, 1130
        • Wiener Gesundheitsverbund Klinik Hietzing
  • Brasile
      • Brasília, Brasile, 70390 700
        • Instituto D Or de Pesquisa e Ensino 1
      • Curitiba, Brasile, 80030 110
        • Ceti - Centro de Estudos Em Terapias Inovadoras
      • Porto Alegre, Brasile, 90035-001
        • Hospital Moinhos de Vento
      • Porto Alegre, Brasile, 90480 000
        • LMK Servicos Medicos S S
      • Porto Alegre, Brasile, 90035 903
        • Hospital De Clinicas De Porto Alegre
      • Ribeirão Preto, Brasile, 14048 900
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
      • Salvador, Brasile, 41253-190
        • IDOR - Regional Bahia
      • Salvador, Brasile, 40150 150
        • SER - Servicos Especializados em Reumatologia da Bahia
      • São José do Rio Preto, Brasile, 15090-000
        • Funfarme Sjrp
      • São Paulo, Brasile, 04266 010
        • CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
      • São Paulo, Brasile, 05403 000
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
      • São Paulo, Brasile, 01243 020
        • Hospital Samaritano de Sao Paulo
      • Vitória, Brasile, 29055 450
        • CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda
  • Bulgaria
      • Plovdiv, Bulgaria, 4001
        • UMHAT Kaspela
      • Plovdiv, Bulgaria, 4002
        • Medical Center Artmed
      • Rousse, Bulgaria, 7003
        • Medical Center Teodora
      • Sofia, Bulgaria, 1431
        • St Ivan Rilski University Multiprofile Hospital For Active Treatment
      • Sofia, Bulgaria, 1431
        • Diagnostic-Consultative Center (DCC) Aleksandrovska
      • Sofia, Bulgaria, 1606
        • Military Medical Academy Multiprofile Hospital for Active Treatment Sofia
      • Sofia, Bulgaria, 1336
        • Lyulin Multi Profile Hospital For Active Medical Treatment
      • Varna, Bulgaria, 9010
        • MHAT 'St. Marina' EAD
      • Varna, Bulgaria, 9000
        • Diagnostic Consultative Center - DCC Equita EOOD
  • Canada
    • Ontario
      • Windsor, Ontario, Canada, N8X 1T3
        • Dr Sabeen Anwar Medicine Professional Corporation
    • Quebec
      • Rimouski, Quebec, Canada, G5L 5T1
        • Hospital Regional de Rimouski
      • Trois-Rivières, Quebec, Canada, G9A 3X2
        • Centre de Recherche Musculo Squelettique
  • Cechia
      • Brno, Cechia, 63800
        • Revmatologie s r o
      • Karvina Frystat, Cechia, 73301
        • Revimex Pro s r o
      • Ostrava, Cechia, 722 00
        • Artroscan s r o
      • Prague, Cechia, 140 00
        • Nuselska Poliklinika
      • Uherské Hradiště, Cechia, 68601
        • MEDICAL PLUS Research, s.r.o.
  • Cina
      • Beijing, Cina, 100191
        • Peking University Third Hospital
      • Beijing, Cina, 100050
        • Beiijing Friendship Hospital, Capital Medical University
      • Changsha, Cina, 410008
        • Xiangya Hospital Central South University
      • Changzhou, Cina, 213164
        • Changzhou No 2 Peoples Hospital
      • Chengdu, Cina, 610041
        • West China Hospital Sichuan University
      • Dazhou, Cina, 635002
        • Dazhou Central Hospital
      • Ganzhou, Cina, 341006
        • First Affiliated Hospital of Gannan Medical University
      • Guangzhou, Cina, 510275
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Guiyang, Cina, 550004
        • The Affiliated Hospital of Guizhou Medical University
      • Hangzhou, Cina, 311608
        • The Second Affiliated Hospital of Zhejiang University College of Medicine
      • Hefei, Cina, 230001
        • Anhui Provincial Hospital
      • Jinan, Cina, 250021
        • Shandong Provincial Hospital
      • Jinhua, Cina, 321013
        • Jinhua municipal central hospital
      • Linyi, Cina, 276002
        • Linyi City People Hospital
      • Nanchang, Cina, 330019
        • The First Affiliated Hospital of NanChang University
      • Nanchong, Cina, 637503
        • Affiliated Hospital of North Sichuan Medical College
      • Nanjing, Cina, 210009
        • Zhongda Hospital Southeast University
      • Nanning, Cina, 530000
        • The People's Hospital of Guangxi Zhuang Autonomous Region
      • Ningbo, Cina, 315041
        • Ningbo medical center lihuili hospital
      • Shanghai, Cina, 200031
        • Huashan Hospital affiliated to Fudan University
      • Shanwei, Cina, 516601
        • Shenshan Medical Center Memorial Hospital of Sun Yat Sen University
      • Shijiazhuang, Cina, 050004
        • The Second Hospital of Hebei Medical University
      • Taiyuan, Cina, 030000
        • Shanxi Academy of Medical Sciences
      • Tianjin, Cina, 300384
        • Tianjin First Central Hospital
      • Wenzhou, Cina, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
      • Xiamen, Cina, 361003
        • The first affiliated hospital of xiamen university
      • Xinxiang, Cina, 453099
        • Xinxiang Central Hospital
      • Xuzhou, Cina, 221000
        • The Affiliated Hospital of Xuzhou Medical University
      • Yinchuan, Cina, 750031
        • People s Hospital of Ningxia Hui Autonomous Region
      • Zhongshan, Cina, 528401
        • Zhongshan Traditional Chinese Medicine Hospital
  • Corea del Sud
      • Gwangju, Corea del Sud, 61469
        • Chonnam National University Hospital
      • Seongnam-si, Corea del Sud, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Corea del Sud, 03080
        • Seoul National University Hospital
      • Seoul, Corea del Sud, 05030
        • Konkuk University Medical Center
      • Seoul, Corea del Sud, 06591
        • The Catholic University of Korea Seoul St Mary s Hospital
      • Seoul, Corea del Sud, 04763
        • Hanyang University Medical Center
      • Suwon, Corea del Sud, 16499
        • Ajou University Hospital
      • Suwon, Corea del Sud, 16247
        • The Catholic university of Korea, St. Vincent's Hospital
  • Danimarca
      • Aarhus, Danimarca, 8200
        • Aarhus University Hospital
      • Copenhagen, Danimarca, 2100
        • Rigshospitalet
      • Køge, Danimarca, 4600
        • Zealand University Hospital
  • Francia
      • Brest, Francia, 29200
        • CHU de Brest - Hopital de la Cavale Blanche
      • Dijon, Francia, 21000
        • CHU Dijon Bourgogne - Hopital Francois Mitterrand
      • Le Kremlin-Bicêtre, Francia, 94270
        • Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud
      • Lille, Francia, 59037
        • CHRU de Lille Hopital Claude Huriez
      • Montpellier, Francia, 34090
        • CHRU Montpellier Hopital Lapeyronie
      • Saint-Priest-en-Jarez, Francia, 42270
        • CHU Saint Etienne Hopital Nord
      • Strasbourg, Francia, 67200
        • CHRU de Strasbourg - Hopital de Hautepierre
      • Talence, Francia, 33400
        • CHU Bordeaux
  • Germania
      • Cologne, Germania, 51149
        • Krankenhaus Porz am Rhein
      • Dresden, Germania, 01307
        • Universitatsklinikum Carl Gustav Carus Dresden
      • Erlangen, Germania, 91054
        • Universitatsklinikum Erlangen Medizinische Klinik 3
      • Freiburg im Breisgau, Germania, 79106
        • Universitatsklinikum Freiburg
      • Hamburg, Germania, 20095
        • Hamburger Rheuma Forschungszentrum II
      • Hanover, Germania, 30625
        • Medizinische Hochschule Hannover
      • Herne, Germania, 44649
        • Rheumazentrum Ruhrgebiet
      • München, Germania, 80336
        • Klinikum der Universitaet Muenchen
      • München, Germania, 81667
        • Medicover Muenchen Ost MVZ
      • Ratingen, Germania, 40878
        • Rheumazentrum Ratingen
      • Würzburg, Germania, 97080
        • Universitaetsklinikum Wuerzburg
  • Giappone
      • Chūōku, Giappone, 104 8560
        • St. Luke's International Hospital
      • Fuchū, Giappone, 183 8524
        • Tokyo Metropolitan Tama Medical Center
      • Fukuoka, Giappone, 810 8563
        • National Hospital Organization Kyushu Medical Center
      • Kawachi-Nagano, Giappone, 586 8521
        • National Hospital Organization Osaka Minami Medical Center
      • Naha, Giappone, 900 0015
        • Shinkenko Clinic
      • Okayama, Giappone, 700 8557
        • Okayama City General Medical Center Okayama City Hospital
      • Sapporo, Giappone, 060 8648
        • Hokkaido University Hospital
      • Sasebo, Giappone, 857 1195
        • Sasebo Chuo Hospital
      • Sendai, Giappone, 983 0005
        • Tohoku Medical And Pharmaceutical University Hospital
      • Shimotsuga Gun, Giappone, 321 0293
        • Dokkyo Medical University Hospital
      • Sumida Ku, Giappone, 130 8575
        • Tokyo Metropolitan Bokutoh Hospital
      • Tokyo, Giappone, 173 8610
        • Nihon University Itabashi Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital
  • Israele
      • Ashkelon, Israele, 7830604
        • Barzilai Medical Center
      • Haifa, Israele, 3109601
        • Rambam Health Care Campus
      • Haifa, Israele, 34362
        • Carmel Medical Center
      • Har Poriyya, Israele, 1528001
        • Tzafon Medical Center Poria
      • Nahariya, Israele, 2210001
        • Galil Medical Center
      • Petah Tikva, Israele, 4941492
        • Rabin Medical Center
      • Ramat Gan, Israele, 5262100
        • Sheba Medical Center
      • Tel Aviv, Israele
        • Sourasky Medical Center
  • Italia
      • Milan, Italia, 20122
        • Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
      • Milan, Italia, 20132
        • Ospedale San Raffaele
      • Palermo, Italia, 90127
        • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
      • Perugia, Italia, 06129
        • Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
      • Pisa, Italia, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Roma, Italia, 00161
        • Umberto I Policlinico di Roma
      • Roma, Italia, 00168
        • Fondazione Policlinico Universitario A Gemelli IRCCS
      • Roma, Italia, 128
        • Campus Bio Medico di Roma
      • Rozzano, Italia, 20089
        • Istituto Clinico Humanitas
      • Udine, Italia, 33100
        • Ospedale S. Maria Della Misericordia
  • Messico
      • Culiacán, Messico, 80000
        • Centro de Investigacion de Tratamientos Innovadores de Sinaloa
      • Guadalajara, Messico, 44650
        • Clinica de Investigacion en Reumatologia y Obesidad
      • Mexico City, Messico, 06720
        • Centro Medico Nacional Siglo XXI IMSS
      • Mexico D F, Messico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
      • Mérida, Messico, 97070
        • Medical Care & Research SA de CV
      • México, Messico, 06700
        • CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V
      • Querétaro, Messico, 76070
        • SMIQ S de R L de C V
      • San Luis Potosí City, Messico, 78213
        • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi
  • Norvegia
      • Oslo, Norvegia, 0372
        • Oslo universitetssykehus HF, Rikshospitalet
      • Stavanger, Norvegia, 4011
        • Stavanger University Hospital
  • Olanda
      • Enschede, Olanda, 7512 KZ
        • Medisch Spectrum Twente
  • Polonia
      • Bydgoszcz, Polonia, 85 065
        • MICS Centrum Medyczne Bydgoszcz
      • Bydgoszcz, Polonia, 85 168
        • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
      • Dębica, Polonia, 39 200
        • ETG Debica
      • Krakow, Polonia, 30-002
        • Malopolskie Badania Kliniczne Sp z o o
      • Krakow, Polonia, 31 501
        • Futuremeds Krakow
      • Lublin, Polonia, 20 412
        • ETG Lublin Poradnie Specjalistyczne
      • Olsztyn, Polonia, 10 117
        • Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A
      • Poznan, Polonia, 61 113
        • AI Centrum Medyczne
      • Siedlce, Polonia, 08 110
        • ETG Siedlce
      • Warsaw, Polonia, 02 637
        • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
      • Warsaw, Polonia, 00 874
        • MICS Centrum Medyczne Warszawa
      • Warsaw, Polonia, 03 291
        • FutureMeds Targowek
      • Wroclaw, Polonia, 52 416
        • Centrum Medyczne Oporow
      • Wroclaw, Polonia, 53 673
        • FutureMeds Wroclaw
  • Portogallo
      • Lisbon, Portogallo, 1649 035
        • Uls Santa Maria - Hosp. Santa Maria
      • Lisbon, Portogallo, 1050 034
        • Ipr Inst Port de Reumatologia
      • Lisbon, Portogallo, 1349 019
        • Uls Lisboa Ocidental - Hosp. Egas Moniz
      • Vila Nova de Gaia, Portogallo, 4434 502
        • Uls Gaia Espinho
  • Regno Unito
      • Cambridge, Regno Unito, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
      • Doncaster, Regno Unito, DN2 5LT
        • Doncaster Royal Infirmary
      • Greater London, Regno Unito, E1 4DG
        • Barts Health NHS Trust
      • Leeds, Regno Unito, LS7 4SA
        • Leeds Teaching Hospitals NHS Trust
      • Liverpool, Regno Unito, L9 7AL
        • University Hospital Aintree
      • London, Regno Unito, TW7 6AF
        • West Middlesex University Hospital
      • Peterborough, Regno Unito, PE3 9GZ
        • Peterborough City Hospital
      • Swindon, Regno Unito, SN3 6BB
        • Great Western Hospital
  • Romania
      • Bucharest, Romania, 020125
        • Spitalul Clinic Colentina
      • Bucharest, Romania, 011172
        • Spitalul Clinic Sf Maria
      • Bucharest, Romania, 030463
        • Policlinica CCBR SRL
      • Bucharest, Romania, 041312
        • Hiperdia SA
      • Cluj-Napoca, Romania, 400006
        • Spitalul Clinic Judetean de Urgenta Cluj
      • Craiova, Romania, 200347
        • Medisof Diagnostic S R L
      • Timișoara, Romania, 300133
        • Selfmed Clinique S.R.L.
  • Spagna
      • Barcelona, Spagna, 08041
        • Hosp. de La Santa Creu I Sant Pau
      • Barcelona, Spagna, 08035
        • Hosp Univ Vall D Hebron
      • Barcelona, Spagna, 08034
        • Hosp. Cima Sanitas Barcelona
      • Huelva, Spagna, 21005
        • Hosp. Gral. Juan Ramon Jimenez
      • Madrid, Spagna, 28041
        • Hosp. Univ. 12 de Octubre
      • Pamplona, Spagna, 310008
        • Hosp. de Navarra
      • Santander, Spagna, 39008
        • Hosp. Univ. Marques de Valdecilla
      • Seville, Spagna, 41010
        • Hosp. Infanta Luisa
  • Stati Uniti
    • California
      • Chula Vista, California, Stati Uniti, 91910
        • Advanced Clinical Research Center
      • La Palma, California, Stati Uniti, 90623
        • Arthritis & Osteoporosis Medical Center - La Palma
      • Mission Viejo, California, Stati Uniti, 92691
        • Providence Medical Foundation
      • Monterey Park, California, Stati Uniti, 91754
        • NovaMed Research
      • San Leandro, California, Stati Uniti, 94578
        • Medvin Clinical Research San Leandro
      • Santa Monica, California, Stati Uniti, 90404
        • Providence Saint John s Health Center
      • Tustin, California, Stati Uniti, 92780
        • Solace Clinical Research California
      • Upland, California, Stati Uniti, 91786
        • Inland Rheumatology Clinical Trials Inc.
    • Colorado
      • Denver, Colorado, Stati Uniti, 80230
        • Denver Arthritis Clinic
    • Florida
      • Clearwater, Florida, Stati Uniti, 33765
        • Clinical Research of West Florida Inc
      • Jacksonville, Florida, Stati Uniti, 32256
        • UF Health Rheumatology
      • New Port Richey, Florida, Stati Uniti, 34652
        • Suncoast Clinical Research
      • Sarasota, Florida, Stati Uniti, 34239
        • Sarasota Arthritis Center
      • South Miami, Florida, Stati Uniti, 33143
        • BioResearch Partner
    • Georgia
      • Suwanee, Georgia, Stati Uniti, 30024
        • Immunology and Rheumatology Research Associates LLC
    • Illinois
      • Skokie, Illinois, Stati Uniti, 60076
        • Clinical Investigation Specialists - Clinic of Robert Hozman
      • Willowbrook, Illinois, Stati Uniti, 60527
        • Willow Rheumatology and Wellness PLLC
    • Iowa
      • Iowa City, Iowa, Stati Uniti, 52242
        • University of Iowa Hospital and Clinics
    • Kansas
      • Kansas City, Kansas, Stati Uniti, 66160
        • University of Kansas Medical Center
    • Michigan
      • Saint Clair Shores, Michigan, Stati Uniti, 48081
        • Clinical Research Institute of Michigan, LLC
    • Minnesota
      • Eagan, Minnesota, Stati Uniti, 55123
        • St. Paul Rheumatology P A
    • Missouri
      • Kansas City, Missouri, Stati Uniti, 64151
        • AARA Clinical Research- Kansas City Physicians Partners
    • New Jersey
      • Voorhees Township, New Jersey, Stati Uniti, 08043
        • Arthritis Rheumatic And Back Disease Associates
    • New York
      • New York, New York, Stati Uniti, 10016
        • Pioneer Clinical Research NY
      • New York, New York, Stati Uniti, 10016
        • NYU Langone Health - Clinical and Translational Science Institute
    • North Carolina
      • Charlotte, North Carolina, Stati Uniti, 28204
        • Joint and Muscle Research Institute
      • Charlotte, North Carolina, Stati Uniti, 28211
        • Atrium Health SouthPark Rheumatology
      • Salisbury, North Carolina, Stati Uniti, 28144
        • Onsite Clinical Solutions
    • Ohio
      • Fairborn, Ohio, Stati Uniti, 45324
        • Wright State Physicians Health Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73116
        • Rheumatology Associates of Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • OMRF Rheumatology Center of Excellence
    • Pennsylvania
      • Duncansville, Pennsylvania, Stati Uniti, 16635
        • Altoona Center For Clinical Research
      • Philadelphia, Pennsylvania, Stati Uniti, 19114
        • Clinical Research Philadelphia
    • South Carolina
      • Summerville, South Carolina, Stati Uniti, 29486
        • Low Country Rheumatology PA
    • Tennessee
      • Jackson, Tennessee, Stati Uniti, 38305
        • West Tennessee Research Institute
      • Murfreesboro, Tennessee, Stati Uniti, 37128
        • AARA Clinical Research - Murfreesboro Medical Clinic
    • Texas
      • Amarillo, Texas, Stati Uniti, 79124
        • Amarillo Medical Specialists LLP
      • Plano, Texas, Stati Uniti, 75024
        • Texas Rheumatology Research Institute LLC
      • Sugar Land, Texas, Stati Uniti, 77479
        • Fort Bend Rheumatology Associates PLLC
      • The Woodlands, Texas, Stati Uniti, 77382
        • Advanced Rheumatology of Houston
    • Utah
      • Layton, Utah, Stati Uniti, 84041
        • Alpine Research TC LLC
    • Virginia
      • Chesapeake, Virginia, Stati Uniti, 23320
        • Tidewater Clinical Research
    • Washington
      • Bellevue, Washington, Stati Uniti, 98004
        • Overlake Arthritis and Osteoporosis Center
  • Svizzera
      • Basel, Svizzera, 4031
        • Universitatsspital Basel
      • Sankt Gallen, Svizzera, 9000
        • Kantonsspital St Gallen
  • Taiwan
      • Hsinchu, Taiwan, 302058
        • NTU Biomedical Park Hospital
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung City, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital
      • New Taipei City, Taiwan, 23561
        • Taipei Medical University Shuang Ho Hospital
      • Taichung, Taiwan, 404332
        • China Medical University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital
  • Turchia (Türkiye)
      • Ankara, Turchia (Türkiye), 06800
        • Ankara Bilkent City Hospital
      • Ankara, Turchia (Türkiye), 06560
        • Gazi University Medical Faculty
      • Ankara, Turchia (Türkiye), 06010
        • Gulhane Training and Research Hospital
      • Bursa, Turchia (Türkiye), 16059
        • Uludag University Medical Faculty
      • Istanbul, Turchia (Türkiye), 34899
        • Marmara University Istanbul Pendik Education and Research Hospital
      • Konya, Turchia (Türkiye), 42090
        • Necmettin Erbakan University
  • Ungheria
      • Budapest, Ungheria, 1033
        • Clinexpert Kft
      • Budapest, Ungheria, 1097
        • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
      • Budapest, Ungheria, 1027
        • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
      • Budapest, Ungheria, 1023
        • Semmelweis Egyetem Reumatologiai es Immunologiai Klinika
      • Debrecen, Ungheria, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Szeged, Ungheria, 6725
        • Szegedi Tudomanyegyetem
      • Székesfehérvár, Ungheria, 8000
        • Vita Verum Medical Egeszsegugyi Szolgaltato Bt

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:-

  • Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
  • Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria
  • Seropositive for antibodies to Ro/SSA (Ro60 and/or Ro52) at screening
  • Total ClinESSDAI score greater than or equal to (>=) 5 at screening
  • Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization

Exclusion Criteria:

  • Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory
  • Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation
  • Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency
  • Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example [e.g.], monoclonal antibodies, intravenous immunoglobulin)
  • Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Nipocalimab

Participants will receive nipocalimab subcutaneously (SC) along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) phase, where they will continue to receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.
Droga: Nipocalimab

Nipocalimab SC.

Altri nomi:
  • JNJ-80202135, JNJ-86507083, M281
Droga: Standard of care treatment

Protocol-defined topical and systemic standard of care background treatments.
Comparatore placebo: Placebo

Participants will receive placebo subcutaneously along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an OLE phase, where they will receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.
Droga: Standard of care treatment

Protocol-defined topical and systemic standard of care background treatments.

Droga: Placebo

Placebo SC.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48
Lasso di tempo: Baseline to Week 48

ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD. The ClinESSDAI includes 11 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain being measured. A higher score represents worse disease symptoms.
Baseline to Week 48

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48
Lasso di tempo: Baseline to Week 48

The ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with Sjogren's syndrome.
Baseline to Week 48
Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline
Lasso di tempo: Baseline to Week 48

ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.
Baseline to Week 48
Change from Baseline in ClinESSDAI Score at Week 8
Lasso di tempo: Baseline to Week 8

ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.
Baseline to Week 8
Change from Baseline in Stimulated Salivary Flow Rate at Week 48
Lasso di tempo: Baseline to Week 48

Stimulated salivary flow is considered a reliable and objective method to evaluate glandular function in SjD patients.
Baseline to Week 48
Change from Baseline in Sjogren's Symptoms Dryness Score at Week 48
Lasso di tempo: Baseline to Week 48

Participants will be asked to report the worst severity of their dryness symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No [specific symptom]" and score 10 indicating "Severe [specific symptom]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren's Symptoms dryness score at Week 48 for US, US reference regions, and other non-US regions will be reported.
Baseline to Week 48
Change from Baseline in Sjogren's Symptoms Joint Pain Score at Week 48
Lasso di tempo: Baseline to Week 48

Participants will be asked to report the worst severity of their joint pain symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No [specific symptom]" and score 10 indicating "Severe [specific symptom]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren's Symptoms joint pain score at Week 48 for US, US reference regions, and other non-US regions will be reported.
Baseline to Week 48
Change from Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Score At Week 48
Lasso di tempo: Baseline to Week 48

ESSPRI is a participant-reported assessment of the severity of dryness, fatigue, and pain associated with primary Sjogren's Syndrome. Participants are asked to rate the severity of dryness, fatigue, and pain on a 0 to 10 NRS, with score 0 indicating "No [specific symptom]" and score 10 indicating "Severe [specific symptom]". A global score, calculated as the mean of the 3 domain scores, ranges from 0 to 10, with higher scores reflecting greater (worse) symptom severity. Change from baseline in Sjogren's Symptoms score at Week 48 for EU, UK & EU reference regions will be reported.
Baseline to Week 48
Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 48
Lasso di tempo: Baseline to Week 48

FACIT-Fatigue version 4.0 is a 13-item questionnaire that assesses participant-reported fatigue and its impact upon daily activities and function over the past 7 days. Participants will be asked to answer each question using a 5-point Likert scale (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; and 4=Very much). FACIT-Fatigue has a total score range from 0 to 52, with 0 being the worst possible score and 52 the best.
Baseline to Week 48

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Research & Development, LLC

Investigatori

  • Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 dicembre 2024

Completamento primario (Stimato)

1 gennaio 2028

Completamento dello studio (Stimato)

18 maggio 2029

Date di iscrizione allo studio

Primo inviato

18 dicembre 2024

Primo inviato che soddisfa i criteri di controllo qualità

18 dicembre 2024

Primo Inserito (Effettivo)

19 dicembre 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 80202135SJS3001
  • 80202135SJS3001 (Altro identificatore: Janssen Research & Development, LLC)
  • 2024-513965-38-00 (Identificatore di registro: EUCT number)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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