A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults With Moderate to Severe Sjogren's Disease (SjD)
Status: Recruiting
Location: See all (197) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Advanced Clinical Research Center
RECRUITING
Chula Vista
Providence Medical Foundation
RECRUITING
Fullerton
Arthritis & Osteoporosis Medical Center - La Palma
RECRUITING
La Palma
NovaMed Research
RECRUITING
Monterey Park
Medvin Clinical Research San Leandro
RECRUITING
San Leandro
Providence Saint John s Health Center
RECRUITING
Santa Monica
Solace Clinical Research California
RECRUITING
Tustin
Inland Rheumatology Clinical Trials Inc.
RECRUITING
Upland
Colorado
Denver Arthritis Clinic
RECRUITING
Denver
Florida
Clinical Research of West Florida Inc
RECRUITING
Clearwater
UF Health Rheumatology
SUSPENDED
Jacksonville
Suncoast Clinical Research
RECRUITING
New Port Richey
Sarasota Arthritis Center
RECRUITING
Sarasota
BioResearch Partner
RECRUITING
South Miami
Iowa
University of Iowa Hospital and Clinics
RECRUITING
Iowa City
Illinois
Clinical Investigation Specialists - Clinic of Robert Hozman
RECRUITING
Skokie
Willow Rheumatology and Wellness PLLC
RECRUITING
Willowbrook
Minnesota
St. Paul Rheumatology P A
RECRUITING
Eagan
North Carolina
Atrium Health SouthPark Rheumatology
RECRUITING
Charlotte
Joint and Muscle Research Institute
RECRUITING
Charlotte
Onsite Clinical Solutions
RECRUITING
Salisbury
Ohio
Wright State Physicians Health Center
RECRUITING
Fairborn
Oklahoma
OMRF Rheumatology Center of Excellence
RECRUITING
Oklahoma City
Pennsylvania
Altoona Center For Clinical Research
RECRUITING
Duncansville
Clinical Research Philadelphia
RECRUITING
Philadelphia
South Carolina
Low Country Rheumatology PA
RECRUITING
Summerville
Tennessee
West Tennessee Research Institute
RECRUITING
Jackson
Texas
Amarillo Premier Research
RECRUITING
Amarillo
Texas Rheumatology Research Institute LLC
RECRUITING
Plano
Utah
Alpine Research TC LLC
RECRUITING
Layton
Virginia
Tidewater Clinical Research
RECRUITING
Chesapeake
Washington
Overlake Arthritis and Osteoporosis Center
RECRUITING
Bellevue
Other Locations
Argentina
Centro de Investigacion San Miguel CISM
RECRUITING
Buenos Aires
Instituto Medico De Alta Complejidad (IMAC)
RECRUITING
Buenos Aires
Mautalen Salud e Investigacion
RECRUITING
Caba
Centro Medico del Dr. Javier Gerardo Tartaglione
RECRUITING
Cdad Autonoma De Buenos Aires
Centro de Investigacion en Enfermedades Reumaticas CIER
RECRUITING
Ciudad De Buenos Aires
Centro Medico Barrio Parque. Swiss Medical Group
RECRUITING
Ciudad De Buenos Aires
Cosultorios Reumatologógicos Pampa
RECRUITING
Ciudad De Buenos Aires
Cer Instituto Medico
RECRUITING
Quilmes
MR Medicina Reumatologica
RECRUITING
San Fernando
Centro de Investigaciones Medicas Tucuman
RECRUITING
San Miguel De Tucumán
Austria
Medizinische Universitaet Graz
RECRUITING
Graz
SCRI CCCIT gem GmbH
RECRUITING
Salzburg
LK Weinviertel Stockerau
RECRUITING
Stockerau
Medizinische Universitaet Wien
RECRUITING
Vienna
Brazil
Instituto D Or de Pesquisa e Ensino
RECRUITING
Brasília
Ceti - Centro de Estudos Em Terapias Inovadoras
RECRUITING
Curitiba
Associacao Hospitalar Moinhos de Vento
RECRUITING
Porto Alegre
Hospital das Clinicas de Porto Alegre
RECRUITING
Porto Alegre
LMK Servicos Medicos S S
RECRUITING
Porto Alegre
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
RECRUITING
Ribeirão Preto
Instituto D Or de Pesquisa e Ensino
RECRUITING
Salvador
SER - Servicos Especializados em Reumatologia da Bahia
RECRUITING
Salvador
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
RECRUITING
São José Do Rio Preto
CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
RECRUITING
São Paulo
EBSERH Empresa de Servicos Hospitalares Hospital Samaritano
RECRUITING
São Paulo
Hospital Das Clinicas Da Faculdade De Medicina Da USP
RECRUITING
São Paulo
CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda
RECRUITING
Vitória
Bulgaria
Medical Center Artmed
RECRUITING
Plovdiv
UMHAT Kaspela
RECRUITING
Plovdiv
Medical Center Teodora
RECRUITING
Rousse
Lyulin Multi Profile Hospital For Active Medical Treatment
RECRUITING
Sofia
Diagnostic Consultative Center - DCC Equita EOOD
RECRUITING
Varna
MHAT 'St. Marina' EAD
RECRUITING
Varna
Canada
Centre de Recherche Musculo Squelettique
RECRUITING
Trois-rivières
Dr Sabeen Anwar Medicine Professional Corporation
RECRUITING
Windsor
China
Beiijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Xiangya Hospital Central South University
RECRUITING
Changsha
Changzhou No 2 Peoples Hospital
RECRUITING
Changzhou
West China Hospital Sichuan University
RECRUITING
Chengdu
Dazhou Central Hospital
RECRUITING
Dazhou
First Affiliated Hospital of Gannan Medical University
RECRUITING
Ganzhou
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University
RECRUITING
Guiyang
The Second Affiliated Hospital of Zhejiang University College of Medicine
RECRUITING
Hangzhou
Anhui Provincial Hospital
RECRUITING
Hefei
Shandong Provincial Hospital
RECRUITING
Jinan
Jinhua municipal central hospital
RECRUITING
Jinhua
Linyi City People Hospital
RECRUITING
Linyi
The First Affiliated Hospital of NanChang University
RECRUITING
Nanchang
Affiliated Hospital of North Sichuan Medical College
RECRUITING
Nanchong
Zhongda Hospital Southeast University
RECRUITING
Nanjing
The People's Hospital of Guangxi Zhuang Autonomous Region
RECRUITING
Nanning
Ningbo medical center lihuili hospital
RECRUITING
Ningbo
Huashan Hospital affiliated to Fudan University
RECRUITING
Shanghai
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Shanxi Academy of Medical Sciences
RECRUITING
Taiyuan
Tianjin First Central Hospital
RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
The first affiliated hospital of xiamen university
RECRUITING
Xiamen
Xinxiang Central Hospital
RECRUITING
Xinxiang
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
People s Hospital of Ningxia Hui Autonomous Region
RECRUITING
Yinchuan
Zhongshan Traditional Chinese Medicine Hospital
RECRUITING
Zhongshan
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Zealand University Hospital
RECRUITING
Køge
France
Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud
RECRUITING
Le Kremlin-bicêtre
CHRU de Lille Hopital Claude Huriez
RECRUITING
Lille
CHU Saint Etienne Hopital Nord
RECRUITING
Saint-priest-en-jarez
CHRU de Strasbourg - Hopital de Hautepierre
RECRUITING
Strasbourg
Germany
Universitatsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Universitätsklinikum Erlangen Medizinische Klinik 3
RECRUITING
Erlangen
Hamburger Rheuma Forschungszentrum II
RECRUITING
Hamburg
Rheumazentrum Ruhrgebiet
RECRUITING
Herne
Medicover Muenchen Ost MVZ
RECRUITING
München
Rheumazentrum Ratingen
RECRUITING
Ratingen
Universitaetsklinikum Wuerzburg
RECRUITING
Würzburg
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hong Kong
Hungary
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
RECRUITING
Budapest
Clinexpert Kft
RECRUITING
Budapest
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
RECRUITING
Budapest
Semmelweis Egyetem Reumatologiai es Immunologiai Klinika
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont
RECRUITING
Debrecen
Szegedi Tudomanyegyetem
RECRUITING
Szeged
Vita Verum Medical Egeszsegugyi Szolgaltato Bt
RECRUITING
Székesfehérvár
Israel
Barzilai Medical Center
RECRUITING
Ashkelon
Rambam Health Care Campus
RECRUITING
Haifa
Tzafon Medical Center Poria
RECRUITING
Har Poriyya
Galil Medical Center
RECRUITING
Nahariya
Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
RECRUITING
Milan
Ospedale San Raffaele
RECRUITING
Milan
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
RECRUITING
Palermo
Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
RECRUITING
Perugia
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Campus Bio Medico di Roma
RECRUITING
Roma
Umberto I Policlinico di Roma
RECRUITING
Roma
Ospedale S. Maria Della Misericordia
RECRUITING
Udine
Japan
St. Luke's International Hospital
RECRUITING
Chūōku
Tokyo Metropolitan Tama Medical Center
RECRUITING
Fuchū
National Hospital Organization Kyushu Medical Center
RECRUITING
Fukuoka
National Hospital Organization Osaka Minami Medical Center
RECRUITING
Kawachi-nagano
Shinkenko Clinic
RECRUITING
Naha
Okayama City General Medical Center Okayama City Hospital
RECRUITING
Okayama
Hokkaido University Hospital
RECRUITING
Sapporo
Sasebo Chuo Hospital
RECRUITING
Sasebo
Tohoku Medical And Pharmaceutical University Hospital
RECRUITING
Sendai
Dokkyo Medical University Hospital
RECRUITING
Shimotsuga Gun
Tokyo Metropolitan Bokutoh Hospital
RECRUITING
Sumida Ku
Nihon University Itabashi Hospital
RECRUITING
Tokyo
Mexico
Centro de Investigacion de Tratamientos Innovadores de Sinaloa
RECRUITING
Culiacán
Clinica de Investigacion en Reumatologia y Obesidad
RECRUITING
Guadalajara
Medical Care & Research SA de CV
RECRUITING
Mérida
CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V
RECRUITING
México
Centro Medico Nacional Siglo XXI IMSS
RECRUITING
Mexico City
SMIQ S de R L de C V
RECRUITING
Querétaro
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi
RECRUITING
San Luis Potosí City
Poland
MICS Centrum Medyczne Bydgoszcz
RECRUITING
Bydgoszcz
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
RECRUITING
Bydgoszcz
Futuremeds Krakow
RECRUITING
Krakow
Malopolskie Badania Kliniczne Sp z o o
RECRUITING
Krakow
Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A
RECRUITING
Olsztyn
AI Centrum Medyczne
RECRUITING
Poznan
FutureMeds Targowek
RECRUITING
Warsaw
MICS Centrum Medyczne Warszawa
RECRUITING
Warsaw
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
RECRUITING
Warsaw
Centrum Medyczne Oporow
RECRUITING
Wroclaw
FutureMeds Wroclaw
RECRUITING
Wroclaw
Portugal
Ipr Inst Port de Reumatologia
RECRUITING
Lisbon
Uls Gaia Espinho
RECRUITING
Vila Nova De Gaia
Republic of Korea
Chonnam National University Hospital
RECRUITING
Gwangju
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Hanyang University Medical Center
RECRUITING
Seoul
Konkuk University Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
The Catholic University of Korea Seoul St Mary s Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
The Catholic university of Korea, St. Vincent's Hospital
RECRUITING
Suwon
Romania
Hiperdia SA
RECRUITING
Bucharest
Policlinica CCBR SRL
RECRUITING
Bucharest
Spitalul Clinic Sf Maria
RECRUITING
Bucharest
Spitalul Clinic Judetean de Urgenta Cluj
RECRUITING
Cluj-napoca
Medisof Diagnostic S R L
RECRUITING
Craiova
Selfmed Clinique S.R.L.
RECRUITING
Timișoara
Spain
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
Hosp. Cima Sanitas Barcelona
RECRUITING
Barcelona
Hosp. de La Santa Creu I Sant Pau
RECRUITING
Barcelona
Hosp. Gral. Juan Ramon Jimenez
RECRUITING
Huelva
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Hosp. de Navarra
RECRUITING
Pamplona
Hosp. Univ. Marques de Valdecilla
RECRUITING
Santander
Hosp. Infanta Luisa
RECRUITING
Seville
Taiwan
NTU Biomedical Park Hospital
RECRUITING
Hsinchu
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Kaohsiung Veterans General Hospital
RECRUITING
Kaohsiung City
Taipei Medical University Shuang Ho Hospital
RECRUITING
New Taipei City
China Medical University Hospital
RECRUITING
Taichung
Taipei Veterans General Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
United Kingdom
Doncaster Royal Infirmary
RECRUITING
Doncaster
Barts Health NHS Trust
RECRUITING
Greater London
University Hospital Aintree
RECRUITING
Liverpool
West Middlesex University Hospital
RECRUITING
London
Peterborough City Hospital
RECRUITING
Peterborough
Great Western Hospital
RECRUITING
Swindon
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2024-12-04
Estimated Completion Date: 2029-08-02
Participants
Target number of participants: 600
Treatments
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC