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Nipocalimab in Moderate to Severe Sjogren's Disease
Sponsor: Janssen Research & Development, LLC
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).
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
655
Start Date
2024-12-04
Completion Date
2029-05-18
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Nipocalimab
Nipocalimab SC.
Placebo
Placebo SC.
Standard of care treatment
Protocol-defined topical and systemic standard of care background treatments.
Locations (254)
Advanced Clinical Research Center
Chula Vista, California, United States
Arthritis & Osteoporosis Medical Center - La Palma
La Palma, California, United States
Providence Medical Foundation
Mission Viejo, 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
Immunology and Rheumatology Research Associates LLC
Suwanee, Georgia, 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
University of Kansas Medical Center
Kansas City, Kansas, 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
AARA Clinical Research - Murfreesboro Medical Clinic
Murfreesboro, Tennessee, United States
Amarillo Medical Specialists LLP
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
Wiener Gesundheitsverbund Klinik Hietzing
Vienna, Austria
Instituto D Or de Pesquisa e Ensino 1
Brasília, Brazil
Ceti - Centro de Estudos Em Terapias Inovadoras
Curitiba, Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, Brazil
Hospital Moinhos de Vento
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
IDOR - Regional Bahia
Salvador, Brazil
Funfarme Sjrp
São José do Rio Preto, Brazil
Hospital Samaritano de Sao Paulo
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
Hospital Regional de Rimouski
Rimouski, Quebec, 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