Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2024-12-04
2029-08-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Nipocalimab
Nipocalimab SC.
Standard of care treatment
Protocol-defined topical and systemic standard of care background treatments.
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.
Placebo
Placebo SC.
Standard of care treatment
Protocol-defined topical and systemic standard of care background treatments.
Interventions
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Nipocalimab
Nipocalimab SC.
Placebo
Placebo SC.
Standard of care treatment
Protocol-defined topical and systemic standard of care background treatments.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Advanced Clinical Research Center
Chula Vista, California, United States
Providence Medical Foundation
Fullerton, California, United States
Arthritis & Osteoporosis Medical Center - La Palma
La Palma, California, United States
NovaMed Research
Monterey Park, California, United States
Medvin Clinical Research San Leandro
San Leandro, California, United States
Providence Saint John s Health Center
Santa Monica, California, United States
Solace Clinical Research California
Tustin, California, United States
Inland Rheumatology Clinical Trials Inc.
Upland, California, United States
Denver Arthritis Clinic
Denver, Colorado, United States
Clinical Research of West Florida Inc
Clearwater, Florida, United States
UF Health Rheumatology
Jacksonville, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Sarasota Arthritis Center
Sarasota, Florida, United States
BioResearch Partner
South Miami, Florida, United States
Clinical Investigation Specialists - Clinic of Robert Hozman
Skokie, Illinois, United States
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Clinical Research Institute of Michigan, LLC
Saint Clair Shores, Michigan, United States
St. Paul Rheumatology P A
Eagan, Minnesota, United States
AARA Clinical Research- Kansas City Physicians Partners
Kansas City, Missouri, United States
Arthritis Rheumatic And Back Disease Associates
Voorhees Township, New Jersey, United States
NYU Langone Health - Clinical and Translational Science Institute
New York, New York, United States
Pioneer Clinical Research NY
New York, New York, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, United States
Atrium Health SouthPark Rheumatology
Charlotte, North Carolina, United States
Onsite Clinical Solutions
Salisbury, North Carolina, United States
Wright State Physicians Health Center
Fairborn, Ohio, United States
OMRF Rheumatology Center of Excellence
Oklahoma City, Oklahoma, United States
Rheumatology Associates of Oklahoma
Oklahoma City, Oklahoma, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research Philadelphia
Philadelphia, Pennsylvania, United States
Low Country Rheumatology PA
Summerville, South Carolina, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Amarillo Premier Research
Amarillo, Texas, United States
Texas Rheumatology Research Institute LLC
Plano, Texas, United States
Fort Bend Rheumatology Associates PLLC
Sugar Land, Texas, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, United States
Alpine Research TC LLC
Layton, Utah, United States
Tidewater Clinical Research
Chesapeake, Virginia, United States
Overlake Arthritis and Osteoporosis Center
Bellevue, Washington, United States
Instituto Medico De Alta Complejidad (IMAC)
Buenos Aires, , Argentina
Centro de Investigacion San Miguel CISM
Buenos Aires, , Argentina
Mautalen Salud e Investigacion
CABA, , Argentina
Centro Medico del Dr. Javier Gerardo Tartaglione
Cdad Autonoma de Buenos Aires, , Argentina
Centro de Investigacion en Enfermedades Reumaticas CIER
Ciudad de Buenos Aires, , Argentina
Centro Medico Barrio Parque. Swiss Medical Group
Ciudad de Buenos Aires, , Argentina
Cosultorios Reumatologógicos Pampa
Ciudad de Buenos Aires, , Argentina
Cer Instituto Medico
Quilmes, , Argentina
MR Medicina Reumatologica
San Fernando, , Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, , Argentina
Medizinische Universitaet Graz
Graz, , Austria
SCRI CCCIT gem GmbH
Salzburg, , Austria
LK Weinviertel Stockerau
Stockerau, , Austria
Medizinische Universitaet Wien
Vienna, , Austria
Instituto D Or de Pesquisa e Ensino
Brasília, , Brazil
Ceti - Centro de Estudos Em Terapias Inovadoras
Curitiba, , Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, , Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, , Brazil
LMK Servicos Medicos S S
Porto Alegre, , Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Ribeirão Preto, , Brazil
SER - Servicos Especializados em Reumatologia da Bahia
Salvador, , Brazil
Instituto D Or de Pesquisa e Ensino
Salvador, , Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, , Brazil
EBSERH Empresa de Servicos Hospitalares Hospital Samaritano
São Paulo, , Brazil
CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
São Paulo, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, , Brazil
CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda
Vitória, , Brazil
UMHAT Kaspela
Plovdiv, , Bulgaria
Medical Center Artmed
Plovdiv, , Bulgaria
Medical Center Teodora
Rousse, , Bulgaria
Lyulin Multi Profile Hospital For Active Medical Treatment
Sofia, , Bulgaria
Diagnostic-Consultative Center (DCC) Aleksandrovska
Sofia, , Bulgaria
St Ivan Rilski University Multiprofile Hospital For Active Treatment
Sofia, , Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment Sofia
Sofia, , Bulgaria
Diagnostic Consultative Center - DCC Equita EOOD
Varna, , Bulgaria
MHAT 'St. Marina' EAD
Varna, , Bulgaria
Dr Sabeen Anwar Medicine Professional Corporation
Windsor, Ontario, Canada
Centre de Recherche Musculo Squelettique
Trois-Rivières, Quebec, Canada
Beiijing Friendship Hospital, Capital Medical University
Beijing, , China
Peking University Third Hospital
Beijing, , China
Xiangya Hospital Central South University
Changsha, , China
Changzhou No 2 Peoples Hospital
Changzhou, , China
West China Hospital Sichuan University
Chengdu, , China
Dazhou Central Hospital
Dazhou, , China
First Affiliated Hospital of Gannan Medical University
Ganzhou, , China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, , China
The Affiliated Hospital of Guizhou Medical University
Guiyang, , China
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, , China
Anhui Provincial Hospital
Hefei, , China
Shandong Provincial Hospital
Jinan, , China
Jinhua municipal central hospital
Jinhua, , China
Linyi City People Hospital
Linyi, , China
The First Affiliated Hospital of NanChang University
Nanchang, , China
Affiliated Hospital of North Sichuan Medical College
Nanchong, , China
Zhongda Hospital Southeast University
Nanjing, , China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, , China
Ningbo medical center lihuili hospital
Ningbo, , China
Huashan Hospital affiliated to Fudan University
Shanghai, , China
The Second Hospital of Hebei Medical University
Shijiazhuang, , China
Shanxi Academy of Medical Sciences
Taiyuan, , China
Tianjin First Central Hospital
Tianjin, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
The first affiliated hospital of xiamen university
Xiamen, , China
Xinxiang Central Hospital
Xinxiang, , China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, , China
People s Hospital of Ningxia Hui Autonomous Region
Yinchuan, , China
Zhongshan Traditional Chinese Medicine Hospital
Zhongshan, , China
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Zealand University Hospital
Køge, , Denmark
CHU Dijon Bourgogne - Hopital Francois Mitterrand
Dijon, , France
Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud
Le Kremlin-Bicêtre, , France
CHRU de Lille Hopital Claude Huriez
Lille, , France
CHU Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, , France
CHRU de Strasbourg - Hopital de Hautepierre
Strasbourg, , France
CHU Bordeaux
Talence, , France
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitätsklinikum Erlangen Medizinische Klinik 3
Erlangen, , Germany
Hamburger Rheuma Forschungszentrum II
Hamburg, , Germany
Rheumazentrum Ruhrgebiet
Herne, , Germany
Medicover Muenchen Ost MVZ
München, , Germany
Rheumazentrum Ratingen
Ratingen, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Semmelweis Egyetem Reumatologiai es Immunologiai Klinika
Budapest, , Hungary
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
Budapest, , Hungary
Clinexpert Kft
Budapest, , Hungary
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Szegedi Tudomanyegyetem
Szeged, , Hungary
Vita Verum Medical Egeszsegugyi Szolgaltato Bt
Székesfehérvár, , Hungary
Barzilai Medical Center
Ashkelon, , Israel
Rambam Health Care Campus
Haifa, , Israel
Tzafon Medical Center Poria
Har Poriyya, , Israel
Galil Medical Center
Nahariya, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Ospedale San Raffaele
Milan, , Italy
Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
Milan, , Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, , Italy
Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
Perugia, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Umberto I Policlinico di Roma
Roma, , Italy
Campus Bio Medico di Roma
Roma, , Italy
Ospedale S. Maria Della Misericordia
Udine, , Italy
St. Luke's International Hospital
Chūōku, , Japan
Tokyo Metropolitan Tama Medical Center
Fuchū, , Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, , Japan
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, , Japan
Shinkenko Clinic
Naha, , Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, , Japan
Hokkaido University Hospital
Sapporo, , Japan
Sasebo Chuo Hospital
Sasebo, , Japan
Tohoku Medical And Pharmaceutical University Hospital
Sendai, , Japan
Dokkyo Medical University Hospital
Shimotsuga Gun, , Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku, , Japan
Nihon University Itabashi Hospital
Tokyo, , Japan
Centro de Investigacion de Tratamientos Innovadores de Sinaloa
Culiacán, , Mexico
Clinica de Investigacion en Reumatologia y Obesidad
Guadalajara, , Mexico
Centro Medico Nacional Siglo XXI IMSS
Mexico City, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico D F, , Mexico
Medical Care & Research SA de CV
Mérida, , Mexico
CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V
México, , Mexico
SMIQ S de R L de C V
Querétaro, , Mexico
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi
San Luis Potosí City, , Mexico
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, , Poland
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
ETG Debica
Dębica, , Poland
Malopolskie Badania Kliniczne Sp z o o
Krakow, , Poland
Futuremeds Krakow
Krakow, , Poland
ETG Lublin Poradnie Specjalistyczne
Lublin, , Poland
Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A
Olsztyn, , Poland
AI Centrum Medyczne
Poznan, , Poland
ETG Siedlce
Siedlce, , Poland
MICS Centrum Medyczne Warszawa
Warsaw, , Poland
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw, , Poland
FutureMeds Targowek
Warsaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
FutureMeds Wroclaw
Wroclaw, , Poland
Ipr Inst Port de Reumatologia
Lisbon, , Portugal
Uls Gaia Espinho
Vila Nova de Gaia, , Portugal
Spitalul Clinic Sf Maria
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Policlinica CCBR SRL
Bucharest, , Romania
Hiperdia SA
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, , Romania
Medisof Diagnostic S R L
Craiova, , Romania
Selfmed Clinique S.R.L.
Timișoara, , Romania
Chonnam National University Hospital
Gwangju, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hanyang University Medical Center
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, , South Korea
The Catholic university of Korea, St. Vincent's Hospital
Suwon, , South Korea
Ajou University Hospital
Suwon, , South Korea
Hosp. Cima Sanitas Barcelona
Barcelona, , Spain
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, , Spain
Hosp. Gral. Juan Ramon Jimenez
Huelva, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp. de Navarra
Pamplona, , Spain
Hosp. Univ. Marques de Valdecilla
Santander, , Spain
Hosp. Infanta Luisa
Seville, , Spain
NTU Biomedical Park Hospital
Hsinchu, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Doncaster Royal Infirmary
Doncaster, , United Kingdom
Barts Health NHS Trust
Greater London, , United Kingdom
University Hospital Aintree
Liverpool, , United Kingdom
West Middlesex University Hospital
London, , United Kingdom
Peterborough City Hospital
Peterborough, , United Kingdom
Great Western Hospital
Swindon, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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80202135SJS3001
Identifier Type: OTHER
Identifier Source: secondary_id
2024-513965-38-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
80202135SJS3001
Identifier Type: -
Identifier Source: org_study_id