Major trial tests potential Game-Changer for debilitating autoimmune disease

NCT ID NCT06741969

Summary

This large, late-stage study is testing whether an investigational drug called nipocalimab can safely reduce disease activity and ease symptoms in adults with moderate to severe Sjogren's disease. It will compare the drug against a placebo in 655 participants over 48 weeks, measuring changes in overall disease severity, dryness, joint pain, and fatigue. The goal is to see if this treatment can better control this chronic autoimmune condition.

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes NO responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • AARA Clinical Research - Murfreesboro Medical Clinic

    Murfreesboro, Tennessee, 37128, United States

  • AARA Clinical Research- Kansas City Physicians Partners

    Kansas City, Missouri, 64151, United States

  • AI Centrum Medyczne

    Poznan, 61 113, Poland

  • Aarhus University Hospital

    Aarhus, 8200, Denmark

  • Advanced Clinical Research Center

    Chula Vista, California, 91910, United States

  • Advanced Rheumatology of Houston

    The Woodlands, Texas, 77382, United States

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, 637503, China

  • Ajou University Hospital

    Suwon, 16499, South Korea

  • Alpine Research TC LLC

    Layton, Utah, 84041, United States

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635, United States

  • Amarillo Premier Research

    Amarillo, Texas, 79124, United States

  • Anhui Provincial Hospital

    Hefei, 230001, China

  • Ankara Bilkent City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Arthritis & Osteoporosis Medical Center - La Palma

    La Palma, California, 90623, United States

  • Arthritis Rheumatic And Back Disease Associates

    Voorhees Township, New Jersey, 08043, United States

  • Artroscan s r o

    Ostrava, 722 00, Czechia

  • Associacao Hospitalar Moinhos de Vento

    Porto Alegre, 90035 901, Brazil

  • Atrium Health SouthPark Rheumatology

    Charlotte, North Carolina, 28211, United States

  • Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia

    Perugia, 06129, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126, Italy

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90127, Italy

  • Barts Health NHS Trust

    Greater London, E1 4DG, United Kingdom

  • Barzilai Medical Center

    Ashkelon, 7830604, Israel

  • Beiijing Friendship Hospital, Capital Medical University

    Beijing, 100050, China

  • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

    Budapest, 1027, Hungary

  • BioResearch Partner

    South Miami, Florida, 33143, United States

  • CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda

    Vitória, 29055 450, Brazil

  • CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos

    São Paulo, 04266 010, Brazil

  • CHRU Montpellier Hopital Lapeyronie

    Montpellier, 34090, France

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59037, France

  • CHRU de Strasbourg - Hopital de Hautepierre

    Strasbourg, 67200, France

  • CHU Bordeaux

    Talence, 33400, France

  • CHU Dijon Bourgogne - Hopital Francois Mitterrand

    Dijon, 21000, France

  • CHU Saint Etienne Hopital Nord

    Saint-Priest-en-Jarez, 42270, France

  • CHU de Brest - Hopital de la Cavale Blanche

    Brest, 29200, France

  • CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V

    México, 06700, Mexico

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Campus Bio Medico di Roma

    Roma, 128, Italy

  • Carmel Medical Center

    Haifa, 34362, Israel

  • Centre de Recherche Musculo Squelettique

    Trois-Rivières, Quebec, G9A 3X2, Canada

  • Centro Medico Barrio Parque. Swiss Medical Group

    Ciudad de Buenos Aires, C1414, Argentina

  • Centro Medico Nacional Siglo XXI IMSS

    Mexico City, 06720, Mexico

  • Centro Medico del Dr. Javier Gerardo Tartaglione

    Cdad Autonoma de Buenos Aires, C1123AAO, Argentina

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO

    Milan, 20122, Italy

  • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi

    San Luis Potosí City, 78213, Mexico

  • Centro de Investigacion San Miguel CISM

    Buenos Aires, B1663GJE, Argentina

  • Centro de Investigacion de Tratamientos Innovadores de Sinaloa

    Culiacán, 80000, Mexico

  • Centro de Investigacion en Enfermedades Reumaticas CIER

    Ciudad de Buenos Aires, C1055, Argentina

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, T4000AXL, Argentina

  • Centrum Medyczne Oporow

    Wroclaw, 52 416, Poland

  • Cer Instituto Medico

    Quilmes, B1878DVB, Argentina

  • Ceti - Centro de Estudos Em Terapias Inovadoras

    Curitiba, 80030 110, Brazil

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213164, China

  • China Medical University Hospital

    Taichung, 404332, Taiwan

  • Chonnam National University Hospital

    Gwangju, 61469, South Korea

  • Clinexpert Kft

    Budapest, 1033, Hungary

  • Clinica de Investigacion en Reumatologia y Obesidad

    Guadalajara, 44650, Mexico

  • Clinical Investigation Specialists - Clinic of Robert Hozman

    Skokie, Illinois, 60076, United States

  • Clinical Research Institute of Michigan, LLC

    Saint Clair Shores, Michigan, 48081, United States

  • Clinical Research Philadelphia

    Philadelphia, Pennsylvania, 19114, United States

  • Clinical Research of West Florida Inc

    Clearwater, Florida, 33765, United States

  • Cosultorios Reumatologógicos Pampa

    Ciudad de Buenos Aires, C1428, Argentina

  • Dazhou Central Hospital

    Dazhou, 635002, China

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

    Budapest, 1097, Hungary

  • Denver Arthritis Clinic

    Denver, Colorado, 80230, United States

  • Diagnostic Consultative Center - DCC Equita EOOD

    Varna, 9000, Bulgaria

  • Diagnostic-Consultative Center (DCC) Aleksandrovska

    Sofia, 1431, Bulgaria

  • Dokkyo Medical University Hospital

    Shimotsuga Gun, 321 0293, Japan

  • Doncaster Royal Infirmary

    Doncaster, DN2 5LT, United Kingdom

  • Dr Sabeen Anwar Medicine Professional Corporation

    Windsor, Ontario, N8X 1T3, Canada

  • EBSERH Empresa de Servicos Hospitalares Hospital Samaritano

    São Paulo, 01229 001, Brazil

  • ETG Debica

    Dębica, 39 200, Poland

  • ETG Lublin Poradnie Specjalistyczne

    Lublin, 20 412, Poland

  • ETG Siedlce

    Siedlce, 08 110, Poland

  • Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A

    Olsztyn, 10 117, Poland

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, 341006, China

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168, Italy

  • Fort Bend Rheumatology Associates PLLC

    Sugar Land, Texas, 77479, United States

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

    São José do Rio Preto, 15090 000, Brazil

  • FutureMeds Targowek

    Warsaw, 03 291, Poland

  • FutureMeds Wroclaw

    Wroclaw, 53 673, Poland

  • Futuremeds Krakow

    Krakow, 31 501, Poland

  • Galil Medical Center

    Nahariya, 2210001, Israel

  • Gazi University Medical Faculty

    Ankara, 06560, Turkey (Türkiye)

  • Great Western Hospital

    Swindon, SN3 6BB, United Kingdom

  • Gulhane Training and Research Hospital

    Ankara, 06010, Turkey (Türkiye)

  • Hamburger Rheuma Forschungszentrum II

    Hamburg, 20095, Germany

  • Hanyang University Medical Center

    Seoul, 04763, South Korea

  • Hiperdia SA

    Bucharest, 041312, Romania

  • Hokkaido University Hospital

    Sapporo, 060 8648, Japan

  • Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud

    Le Kremlin-Bicêtre, 94270, France

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp. Cima Sanitas Barcelona

    Barcelona, 08034, Spain

  • Hosp. Gral. Juan Ramon Jimenez

    Huelva, 21005, Spain

  • Hosp. Infanta Luisa

    Seville, 41010, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008, Spain

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08041, Spain

  • Hosp. de Navarra

    Pamplona, 310008, Spain

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403 000, Brazil

  • Hospital Regional de Rimouski

    Rimouski, Quebec, G5L 5T1, Canada

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

    Ribeirão Preto, 14048 900, Brazil

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-903, Brazil

  • Huashan Hospital affiliated to Fudan University

    Shanghai, 200031, China

  • Immunology and Rheumatology Research Associates LLC

    Suwanee, Georgia, 30024, United States

  • Inland Rheumatology Clinical Trials Inc.

    Upland, California, 91786, United States

  • Instituto D Or de Pesquisa e Ensino

    Brasília, 70390 700, Brazil

  • Instituto D Or de Pesquisa e Ensino

    Salvador, 41253 190, Brazil

  • Instituto Medico De Alta Complejidad (IMAC)

    Buenos Aires, B1643CRO, Argentina

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico D F, 14080, Mexico

  • Ipr Inst Port de Reumatologia

    Lisbon, 1050 034, Portugal

  • Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Jinhua municipal central hospital

    Jinhua, 321013, China

  • Joint and Muscle Research Institute

    Charlotte, North Carolina, 28204, United States

  • Kantonsspital St Gallen

    Sankt Gallen, 9000, Switzerland

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833, Taiwan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362, Taiwan

  • Klinikum der Universitaet Muenchen

    München, 80336, Germany

  • Konkuk University Medical Center

    Seoul, 05030, South Korea

  • Krankenhaus Porz am Rhein

    Cologne, 51149, Germany

  • LK Weinviertel Stockerau

    Stockerau, 2000, Austria

  • LMK Servicos Medicos S S

    Porto Alegre, 90480 000, Brazil

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS7 4SA, United Kingdom

  • Linkou Chang Gung Memorial Hospital

    Taoyuan District, 333, Taiwan

  • Linyi City People Hospital

    Linyi, 276002, China

  • Low Country Rheumatology PA

    Summerville, South Carolina, 29486, United States

  • Lyulin Multi Profile Hospital For Active Medical Treatment

    Sofia, 1336, Bulgaria

  • MEDICAL PLUS Research, s.r.o.

    Uherské Hradiště, 68601, Czechia

  • MHAT 'St. Marina' EAD

    Varna, 9010, Bulgaria

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85 065, Poland

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00 874, Poland

  • MR Medicina Reumatologica

    San Fernando, B1646GHP, Argentina

  • Malopolskie Badania Kliniczne Sp z o o

    Krakow, 30-002, Poland

  • Marmara University Istanbul Pendik Education and Research Hospital

    Istanbul, 34899, Turkey (Türkiye)

  • Mautalen Salud e Investigacion

    CABA, C1128AAF, Argentina

  • Medical Care & Research SA de CV

    Mérida, 97070, Mexico

  • Medical Center Artmed

    Plovdiv, 4002, Bulgaria

  • Medical Center Teodora

    Rousse, 7003, Bulgaria

  • Medicover Muenchen Ost MVZ

    München, 81667, Germany

  • Medisch Spectrum Twente

    Enschede, 7512 KZ, Netherlands

  • Medisof Diagnostic S R L

    Craiova, 200347, Romania

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Medizinische Universitaet Graz

    Graz, 8036, Austria

  • Medizinische Universitaet Wien

    Vienna, 1090, Austria

  • Medvin Clinical Research San Leandro

    San Leandro, California, 94578, United States

  • Military Medical Academy Multiprofile Hospital for Active Treatment Sofia

    Sofia, 1606, Bulgaria

  • NTU Biomedical Park Hospital

    Hsinchu, 302058, Taiwan

  • NYU Langone Health - Clinical and Translational Science Institute

    New York, New York, 10016, United States

  • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

    Warsaw, 02 637, Poland

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810 8563, Japan

  • National Hospital Organization Osaka Minami Medical Center

    Kawachi-Nagano, 586 8521, Japan

  • Necmettin Erbakan University

    Konya, 42090, Turkey (Türkiye)

  • Nihon University Itabashi Hospital

    Tokyo, 173 8610, Japan

  • Ningbo medical center lihuili hospital

    Ningbo, 315041, China

  • NovaMed Research

    Monterey Park, California, 91754, United States

  • Nuselska Poliklinika

    Prague, 140 00, Czechia

  • OMRF Rheumatology Center of Excellence

    Oklahoma City, Oklahoma, 73104, United States

  • Okayama City General Medical Center Okayama City Hospital

    Okayama, 700 8557, Japan

  • Onsite Clinical Solutions

    Salisbury, North Carolina, 28144, United States

  • Oslo universitetssykehus HF, Rikshospitalet

    Oslo, 0372, Norway

  • Ospedale S. Maria Della Misericordia

    Udine, 33100, Italy

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Overlake Arthritis and Osteoporosis Center

    Bellevue, Washington, 98004, United States

  • Peking University Third Hospital

    Beijing, 100191, China

  • People s Hospital of Ningxia Hui Autonomous Region

    Yinchuan, 750031, China

  • Peterborough City Hospital

    Peterborough, PE3 9GZ, United Kingdom

  • Pioneer Clinical Research NY

    New York, New York, 10016, United States

  • Policlinica CCBR SRL

    Bucharest, 030463, Romania

  • Providence Medical Foundation

    Fullerton, California, 92835, United States

  • Providence Saint John s Health Center

    Santa Monica, California, 90404, United States

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Rabin Medical Center

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Revimex Pro s r o

    Karvina Frystat, 73301, Czechia

  • Revmatologie s r o

    Brno, 63800, Czechia

  • Rheumatology Associates of Oklahoma

    Oklahoma City, Oklahoma, 73116, United States

  • Rheumazentrum Ratingen

    Ratingen, 40878, Germany

  • Rheumazentrum Ruhrgebiet

    Herne, 44649, Germany

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • SCRI CCCIT gem GmbH

    Salzburg, 5020, Austria

  • SER - Servicos Especializados em Reumatologia da Bahia

    Salvador, 40150 150, Brazil

  • SMIQ S de R L de C V

    Querétaro, 76070, Mexico

  • Sarasota Arthritis Center

    Sarasota, Florida, 34239, United States

  • Sasebo Chuo Hospital

    Sasebo, 857 1195, Japan

  • Selfmed Clinique S.R.L.

    Timișoara, 300133, Romania

  • Semmelweis Egyetem Reumatologiai es Immunologiai Klinika

    Budapest, 1023, Hungary

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shandong Provincial Hospital

    Jinan, 250021, China

  • Shanxi Academy of Medical Sciences

    Taiyuan, 030000, China

  • Sheba Medical Center

    Ramat Gan, 5262100, Israel

  • Shenshan Medical Center Memorial Hospital of Sun Yat Sen University

    Shanwei, 516601, China

  • Shinkenko Clinic

    Naha, 900 0015, Japan

  • Solace Clinical Research California

    Tustin, California, 92780, United States

  • Sourasky Medical Center

    Tel Aviv, Israel

  • Spitalul Clinic Colentina

    Bucharest, 020125, Romania

  • Spitalul Clinic Judetean de Urgenta Cluj

    Cluj-Napoca, 400006, Romania

  • Spitalul Clinic Sf Maria

    Bucharest, 011172, Romania

  • St Ivan Rilski University Multiprofile Hospital For Active Treatment

    Sofia, 1431, Bulgaria

  • St. Luke's International Hospital

    Chūōku, 104 8560, Japan

  • St. Paul Rheumatology P A

    Eagan, Minnesota, 55123, United States

  • Stavanger University Hospital

    Stavanger, 4011, Norway

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, 510275, China

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652, United States

  • Szegedi Tudomanyegyetem

    Szeged, 6725, Hungary

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85 168, Poland

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Texas Rheumatology Research Institute LLC

    Plano, Texas, 75024, United States

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, 550004, China

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, 221000, China

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591, South Korea

  • The Catholic university of Korea, St. Vincent's Hospital

    Suwon, 16247, South Korea

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330019, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000, China

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, 530000, China

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    Hangzhou, 311608, China

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, 050004, China

  • The first affiliated hospital of xiamen university

    Xiamen, 361003, China

  • Tianjin First Central Hospital

    Tianjin, 300384, China

  • Tidewater Clinical Research

    Chesapeake, Virginia, 23320, United States

  • Tohoku Medical And Pharmaceutical University Hospital

    Sendai, 983 0005, Japan

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida Ku, 130 8575, Japan

  • Tokyo Metropolitan Tama Medical Center

    Fuchū, 183 8524, Japan

  • Tuen Mun Hospital

    Hong Kong, Hong Kong

  • Tzafon Medical Center Poria

    Har Poriyya, 1528001, Israel

  • UF Health Rheumatology

    Jacksonville, Florida, 32256, United States

  • UMHAT Kaspela

    Plovdiv, 4001, Bulgaria

  • Uls Gaia Espinho

    Vila Nova de Gaia, 4434 502, Portugal

  • Uls Lisboa Ocidental - Hosp. Egas Moniz

    Lisbon, 1349 019, Portugal

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon, 1649 035, Portugal

  • Uludag University Medical Faculty

    Bursa, 16059, Turkey (Türkiye)

  • Umberto I Policlinico di Roma

    Roma, 00161, Italy

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080, Germany

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitatsspital Basel

    Basel, 4031, Switzerland

  • University Hospital Aintree

    Liverpool, L9 7AL, United Kingdom

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • Universitätsklinikum Erlangen Medizinische Klinik 3

    Erlangen, 91054, Germany

  • Vita Verum Medical Egeszsegugyi Szolgaltato Bt

    Székesfehérvár, 8000, Hungary

  • West China Hospital Sichuan University

    Chengdu, 610041, China

  • West Middlesex University Hospital

    London, TW7 6AF, United Kingdom

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305, United States

  • Wiener Gesundheitsverbund Klinik Hietzing

    Vienna, 1130, Austria

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois, 60527, United States

  • Wright State Physicians Health Center

    Fairborn, Ohio, 45324, United States

  • Xiangya Hospital Central South University

    Changsha, 410008, China

  • Xinxiang Central Hospital

    Xinxiang, 453099, China

  • Zealand University Hospital

    Køge, 4600, Denmark

  • Zhongda Hospital Southeast University

    Nanjing, 210009, China

  • Zhongshan Traditional Chinese Medicine Hospital

    Zhongshan, 528401, China

Conditions

Explore the condition pages connected to this study.