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ACTIVE NOT RECRUITING
NCT06741969
PHASE3

Nipocalimab in Moderate to Severe Sjogren's Disease

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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

2029-08-02

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Nipocalimab

Nipocalimab SC.

DRUG

Placebo

Placebo SC.

DRUG

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

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

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 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

Wiener Gesundheitsverbund Klinik Hietzing

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

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

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

Shenshan Medical Center Memorial Hospital of Sun Yat Sen University

Shanwei, 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

Revmatologie s r o

Brno, Czechia

Revimex Pro s r o

Karvina Frystat, Czechia

Artroscan s r o

Ostrava, Czechia

Nuselska Poliklinika

Prague, Czechia

MEDICAL PLUS Research, s.r.o.

Uherské Hradiště, Czechia

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Zealand University Hospital

Køge, Denmark

CHU de Brest - Hopital de la Cavale Blanche

Brest, France

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

CHRU Montpellier Hopital Lapeyronie

Montpellier, France

CHU Saint Etienne Hopital Nord

Saint-Priest-en-Jarez, France

CHRU de Strasbourg - Hopital de Hautepierre

Strasbourg, France

CHU Bordeaux

Talence, France

Krankenhaus Porz am Rhein

Cologne, Germany

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Universitätsklinikum Erlangen Medizinische Klinik 3

Erlangen, Germany

Universitatsklinikum Freiburg

Freiburg im Breisgau, Germany

Hamburger Rheuma Forschungszentrum II

Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Rheumazentrum Ruhrgebiet

Herne, Germany

Klinikum der Universitaet Muenchen

München, Germany

Medicover Muenchen Ost MVZ

München, Germany

Rheumazentrum Ratingen

Ratingen, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Queen Mary Hospital

Hong Kong, Hong Kong

Tuen Mun 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

Carmel Medical Center

Haifa, Israel

Tzafon Medical Center Poria

Har Poriyya, Israel

Galil Medical Center

Nahariya, Israel

Rabin Medical Center

Petah Tikva, 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

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, Italy

Campus Bio Medico di Roma

Roma, Italy

Istituto Clinico Humanitas

Rozzano, 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

Medisch Spectrum Twente

Enschede, Netherlands

Oslo universitetssykehus HF, Rikshospitalet

Oslo, Norway

Stavanger University Hospital

Stavanger, Norway

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 Lisboa Ocidental - Hosp. Egas Moniz

Lisbon, Portugal

Uls Santa Maria - Hosp. Santa Maria

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

Universitatsspital Basel

Basel, Switzerland

Kantonsspital St Gallen

Sankt Gallen, Switzerland

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

Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)

Gazi University Medical Faculty

Ankara, Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Uludag University Medical Faculty

Bursa, Turkey (Türkiye)

Marmara University Istanbul Pendik Education and Research Hospital

Istanbul, Turkey (Türkiye)

Necmettin Erbakan University

Konya, Turkey (Türkiye)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Doncaster Royal Infirmary

Doncaster, United Kingdom

Barts Health NHS Trust

Greater London, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, 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