Nipocalimab in Moderate to Severe Sjogren's Disease (DAFFODIL)

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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Sjogrens Syndrome
• Intervention / Treatment: Drug: Nipocalimab; Drug: Standard of care treatment; Drug: Placebo

Detailed Description

This clinical development program for nipocalimab in SjD includes 2 identical double blind, placebo-controlled studies to evaluate the efficacy, safety, and tolerability of nipocalimab in participants greater than or equal to (>=) 18 years of age with moderate to severe SjD.

• Study Type: Interventional
• Enrollment (Actual): 655
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, B1643CRO
    • Instituto Medico De Alta Complejidad (IMAC)
  • Buenos Aires, Argentina, B1663GJE
    • Centro de Investigacion San Miguel CISM
  • CABA, Argentina, C1128AAF
    • Mautalen Salud e Investigacion
  • Cdad Autonoma de Buenos Aires, Argentina, C1123AAO
    • Centro Medico del Dr. Javier Gerardo Tartaglione
  • Ciudad de Buenos Aires, Argentina, C1055
    • Centro de Investigacion en Enfermedades Reumaticas CIER
  • Ciudad de Buenos Aires, Argentina, C1414
    • Centro Medico Barrio Parque. Swiss Medical Group
  • Ciudad de Buenos Aires, Argentina, C1428
    • Cosultorios Reumatologógicos Pampa
  • Quilmes, Argentina, B1878DVB
    • Cer Instituto Medico
  • San Fernando, Argentina, B1646GHP
    • MR Medicina Reumatologica
  • San Miguel de Tucumán, Argentina, T4000AXL
    • Centro de Investigaciones Medicas Tucuman
• Austria
  • Graz, Austria, 8036
    • Medizinische Universitaet Graz
  • Salzburg, Austria, 5020
    • SCRI CCCIT gem GmbH
  • Stockerau, Austria, 2000
    • LK Weinviertel Stockerau
  • Vienna, Austria, 1090
    • Medizinische Universitaet Wien
  • Vienna, Austria, 1130
    • Wiener Gesundheitsverbund Klinik Hietzing
• Brazil
  • Brasília, Brazil, 70390 700
    • Instituto D Or de Pesquisa e Ensino 1
  • Curitiba, Brazil, 80030 110
    • Ceti - Centro de Estudos Em Terapias Inovadoras
  • Porto Alegre, Brazil, 90035-903
    • Hospital das Clinicas de Porto Alegre
  • Porto Alegre, Brazil, 90480 000
    • LMK Servicos Medicos S S
  • Porto Alegre, Brazil, 90560032
    • Associacao Hospitalar Moinhos de Vento
  • Ribeirão Preto, Brazil, 14048 900
    • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
  • Salvador, Brazil, 40150 150
    • SER - Servicos Especializados em Reumatologia da Bahia
  • Salvador, Brazil, 41253 190
    • Instituto D Or de Pesquisa e Ensino
  • São José do Rio Preto, Brazil, 15090 000
    • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
  • São Paulo, Brazil, 01229 001
    • EBSERH Empresa de Servicos Hospitalares Hospital Samaritano
  • São Paulo, Brazil, 04266 010
    • CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
  • São Paulo, Brazil, 05403 000
    • Hospital Das Clinicas Da Faculdade De Medicina Da USP
  • Vitória, Brazil, 29055 450
    • CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda
• Bulgaria
  • Plovdiv, Bulgaria, 4001
    • UMHAT Kaspela
  • Plovdiv, Bulgaria, 4002
    • Medical Center Artmed
  • Rousse, Bulgaria, 7003
    • Medical Center Teodora
  • Sofia, Bulgaria, 1431
    • St Ivan Rilski University Multiprofile Hospital For Active Treatment
  • Sofia, Bulgaria, 1431
    • Diagnostic-Consultative Center (DCC) Aleksandrovska
  • Sofia, Bulgaria, 1606
    • Military Medical Academy Multiprofile Hospital for Active Treatment Sofia
  • Sofia, Bulgaria, 1336
    • Lyulin Multi Profile Hospital For Active Medical Treatment
  • Varna, Bulgaria, 9010
    • MHAT 'St. Marina' EAD
  • Varna, Bulgaria, 9000
    • Diagnostic Consultative Center - DCC Equita EOOD
• Canada
  • Ontario
    • Windsor, Ontario, Canada, N8X 1T3
      • Dr Sabeen Anwar Medicine Professional Corporation
  • Quebec
    • Rimouski, Quebec, Canada, G5L 5T1
      • Hospital Regional de Rimouski
    • Trois-Rivières, Quebec, Canada, G9A 3X2
      • Centre de Recherche Musculo Squelettique
• China
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100050
    • Beiijing Friendship Hospital, Capital Medical University
  • Changsha, China, 410008
    • Xiangya Hospital Central South University
  • Changzhou, China, 213164
    • Changzhou No 2 Peoples Hospital
  • Chengdu, China, 610041
    • West China Hospital Sichuan University
  • Dazhou, China, 635002
    • Dazhou Central Hospital
  • Ganzhou, China, 341006
    • First Affiliated Hospital of Gannan Medical University
  • Guangzhou, China, 510275
    • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • Guiyang, China, 550004
    • The Affiliated Hospital of Guizhou Medical University
  • Hangzhou, China, 311608
    • The Second Affiliated Hospital of Zhejiang University College of Medicine
  • Hefei, China, 230001
    • Anhui Provincial Hospital
  • Jinan, China, 250021
    • Shandong Provincial Hospital
  • Jinhua, China, 321013
    • Jinhua municipal central hospital
  • Linyi, China, 276002
    • Linyi City People Hospital
  • Nanchang, China, 330019
    • The First Affiliated Hospital of NanChang University
  • Nanchong, China, 637503
    • Affiliated Hospital of North Sichuan Medical College
  • Nanjing, China, 210009
    • Zhongda Hospital Southeast University
  • Nanning, China, 530000
    • The People's Hospital of Guangxi Zhuang Autonomous Region
  • Ningbo, China, 315041
    • Ningbo medical center lihuili hospital
  • Shanghai, China, 200031
    • Huashan Hospital affiliated to Fudan University
  • Shanwei, China, 516601
    • Shenshan Medical Center Memorial Hospital of Sun Yat Sen University
  • Shijiazhuang, China, 050004
    • The Second Hospital of Hebei Medical University
  • Taiyuan, China, 030000
    • Shanxi Academy of Medical Sciences
  • Tianjin, China, 300384
    • Tianjin First Central Hospital
  • Wenzhou, China, 325000
    • The First Affiliated Hospital of Wenzhou Medical University
  • Xiamen, China, 361003
    • The first affiliated hospital of xiamen university
  • Xinxiang, China, 453099
    • Xinxiang Central Hospital
  • Xuzhou, China, 221000
    • The Affiliated Hospital of Xuzhou Medical University
  • Yinchuan, China, 750031
    • People s Hospital of Ningxia Hui Autonomous Region
  • Zhongshan, China, 528401
    • Zhongshan Traditional Chinese Medicine Hospital
• Czechia
  • Brno, Czechia, 63800
    • Revmatologie s r o
  • Karvina Frystat, Czechia, 73301
    • Revimex Pro s r o
  • Ostrava, Czechia, 722 00
    • Artroscan s r o
  • Prague, Czechia, 140 00
    • Nuselska Poliklinika
  • Uherské Hradiště, Czechia, 68601
    • MEDICAL PLUS Research, s.r.o.
• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
  • Køge, Denmark, 4600
    • Zealand University Hospital
• France
  • Brest, France, 29200
    • CHU de Brest - Hopital de la Cavale Blanche
  • Dijon, France, 21000
    • CHU Dijon Bourgogne - Hopital Francois Mitterrand
  • Le Kremlin-Bicêtre, France, 94270
    • Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud
  • Lille, France, 59037
    • CHRU de Lille Hopital Claude Huriez
  • Montpellier, France, 34090
    • CHRU Montpellier Hopital Lapeyronie
  • Saint-Priest-en-Jarez, France, 42270
    • CHU Saint Etienne Hopital Nord
  • Strasbourg, France, 67200
    • CHRU de Strasbourg - Hopital de Hautepierre
  • Talence, France, 33400
    • CHU Bordeaux
• Germany
  • Cologne, Germany, 51149
    • Krankenhaus Porz am Rhein
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustav Carus Dresden
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen Medizinische Klinik 3
  • Freiburg im Breisgau, Germany, 79106
    • Universitatsklinikum Freiburg
  • Hamburg, Germany, 20095
    • Hamburger Rheuma Forschungszentrum II
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Herne, Germany, 44649
    • Rheumazentrum Ruhrgebiet
  • München, Germany, 80336
    • Klinikum der Universitaet Muenchen
  • München, Germany, 81667
    • Medicover Muenchen Ost MVZ
  • Ratingen, Germany, 40878
    • Rheumazentrum Ratingen
  • Würzburg, Germany, 97080
    • Universitaetsklinikum Wuerzburg
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Tuen Mun Hospital
• Hungary
  • Budapest, Hungary, 1033
    • Clinexpert Kft
  • Budapest, Hungary, 1097
    • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
  • Budapest, Hungary, 1027
    • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
  • Budapest, Hungary, 1023
    • Semmelweis Egyetem Reumatologiai es Immunologiai Klinika
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Szeged, Hungary, 6725
    • Szegedi Tudomanyegyetem
  • Székesfehérvár, Hungary, 8000
    • Vita Verum Medical Egeszsegugyi Szolgaltato Bt
• Israel
  • Ashkelon, Israel, 7830604
    • Barzilai Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Haifa, Israel, 34362
    • Carmel Medical Center
  • Har Poriyya, Israel, 1528001
    • Tzafon Medical Center Poria
  • Nahariya, Israel, 2210001
    • Galil Medical Center
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center
  • Ramat Gan, Israel, 5262100
    • Sheba Medical Center
  • Tel Aviv, Israel
    • Sourasky Medical Center
• Italy
  • Milan, Italy, 20132
    • Ospedale San Raffaele
  • Milan, Italy, 20122
    • Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
  • Palermo, Italy, 90127
    • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
  • Perugia, Italy, 06129
    • Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana
  • Roma, Italy, 00161
    • Umberto I Policlinico di Roma
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A Gemelli IRCCS
  • Roma, Italy, 128
    • Campus Bio Medico di Roma
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas
  • Udine, Italy, 33100
    • Ospedale S. Maria Della Misericordia
• Japan
  • Chūōku, Japan, 104 8560
    • St. Luke's International Hospital
  • Fuchū, Japan, 183 8524
    • Tokyo Metropolitan Tama Medical Center
  • Fukuoka, Japan, 810 8563
    • National Hospital Organization Kyushu Medical Center
  • Kawachi-Nagano, Japan, 586 8521
    • National Hospital Organization Osaka Minami Medical Center
  • Naha, Japan, 900 0015
    • Shinkenko Clinic
  • Okayama, Japan, 700 8557
    • Okayama City General Medical Center Okayama City Hospital
  • Sapporo, Japan, 060 8648
    • Hokkaido University Hospital
  • Sasebo, Japan, 857 1195
    • Sasebo Chuo Hospital
  • Sendai, Japan, 983 0005
    • Tohoku Medical And Pharmaceutical University Hospital
  • Shimotsuga Gun, Japan, 321 0293
    • Dokkyo Medical University Hospital
  • Sumida Ku, Japan, 130 8575
    • Tokyo Metropolitan Bokutoh Hospital
  • Tokyo, Japan, 173 8610
    • Nihon University Itabashi Hospital
• Mexico
  • Culiacán, Mexico, 80000
    • Centro de Investigacion de Tratamientos Innovadores de Sinaloa
  • Guadalajara, Mexico, 44650
    • Clinica de Investigacion en Reumatologia y Obesidad
  • Mexico City, Mexico, 06720
    • Centro Medico Nacional Siglo XXI IMSS
  • Mexico D F, Mexico, 14080
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Mérida, Mexico, 97070
    • Medical Care & Research SA de CV
  • México, Mexico, 06700
    • CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V
  • Querétaro, Mexico, 76070
    • SMIQ S de R L de C V
  • San Luis Potosí City, Mexico, 78213
    • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi
• Netherlands
  • Enschede, Netherlands, 7512 KZ
    • Medisch Spectrum Twente
• Norway
  • Oslo, Norway, 0372
    • Oslo universitetssykehus HF, Rikshospitalet
  • Stavanger, Norway, 4011
    • Stavanger University Hospital
• Poland
  • Bydgoszcz, Poland, 85 168
    • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
  • Bydgoszcz, Poland, 85 065
    • MICS Centrum Medyczne Bydgoszcz
  • Dębica, Poland, 39 200
    • ETG Debica
  • Krakow, Poland, 30-002
    • Malopolskie Badania Kliniczne Sp z o o
  • Krakow, Poland, 31 501
    • Futuremeds Krakow
  • Lublin, Poland, 20 412
    • ETG Lublin Poradnie Specjalistyczne
  • Olsztyn, Poland, 10 117
    • Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A
  • Poznan, Poland, 61 113
    • AI Centrum Medyczne
  • Siedlce, Poland, 08 110
    • ETG Siedlce
  • Warsaw, Poland, 02 637
    • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
  • Warsaw, Poland, 03 291
    • FutureMeds Targowek
  • Warsaw, Poland, 00 874
    • MICS Centrum Medyczne Warszawa
  • Wroclaw, Poland, 52 416
    • Centrum Medyczne Oporow
  • Wroclaw, Poland, 53 673
    • FutureMeds Wroclaw
• Portugal
  • Lisbon, Portugal, 1649 035
    • Uls Santa Maria - Hosp. Santa Maria
  • Lisbon, Portugal, 1050 034
    • Ipr Inst Port de Reumatologia
  • Lisbon, Portugal, 1349 019
    • Uls Lisboa Ocidental - Hosp. Egas Moniz
  • Vila Nova de Gaia, Portugal, 4434 502
    • Uls Gaia Espinho
• Romania
  • Bucharest, Romania, 020125
    • Spitalul Clinic Colentina
  • Bucharest, Romania, 011172
    • Spitalul Clinic Sf Maria
  • Bucharest, Romania, 030463
    • Policlinica CCBR SRL
  • Bucharest, Romania, 041312
    • Hiperdia SA
  • Cluj-Napoca, Romania, 400006
    • Spitalul Clinic Judetean de Urgenta Cluj
  • Craiova, Romania, 200347
    • Medisof Diagnostic S R L
  • Timișoara, Romania, 300133
    • Selfmed Clinique S.R.L.
• South Korea
  • Gwangju, South Korea, 61469
    • Chonnam National University Hospital
  • Seongnam-si, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05030
    • Konkuk University Medical Center
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Mary s Hospital
  • Seoul, South Korea, 04763
    • Hanyang University Medical Center
  • Suwon, South Korea, 16499
    • Ajou University Hospital
  • Suwon, South Korea, 16247
    • The Catholic university of Korea, St. Vincent's Hospital
• Spain
  • Barcelona, Spain, 08041
    • Hosp. de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08035
    • Hosp Univ Vall D Hebron
  • Barcelona, Spain, 08034
    • Hosp. Cima Sanitas Barcelona
  • Huelva, Spain, 21005
    • Hosp. Gral. Juan Ramon Jimenez
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Pamplona, Spain, 310008
    • Hosp. de Navarra
  • Santander, Spain, 39008
    • Hosp. Univ. Marques de Valdecilla
  • Seville, Spain, 41010
    • Hosp. Infanta Luisa
• Switzerland
  • Basel, Switzerland, 4031
    • Universitatsspital Basel
  • Sankt Gallen, Switzerland, 9000
    • Kantonsspital St Gallen
• Taiwan
  • Hsinchu, Taiwan, 302058
    • NTU Biomedical Park Hospital
  • Kaohsiung City, Taiwan, 81362
    • Kaohsiung Veterans General Hospital
  • Kaohsiung City, Taiwan, 833
    • Kaohsiung Chang Gung Memorial Hospital
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University Shuang Ho Hospital
  • Taichung, Taiwan, 404332
    • China Medical University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent City Hospital
  • Ankara, Turkey (Türkiye), 06560
    • Gazi University Medical Faculty
  • Ankara, Turkey (Türkiye), 06010
    • Gulhane Training and Research Hospital
  • Bursa, Turkey (Türkiye), 16059
    • Uludag University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34899
    • Marmara University Istanbul Pendik Education and Research Hospital
  • Konya, Turkey (Türkiye), 42090
    • Necmettin Erbakan University
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust
  • Doncaster, United Kingdom, DN2 5LT
    • Doncaster Royal Infirmary
  • Greater London, United Kingdom, E1 4DG
    • Barts Health NHS Trust
  • Leeds, United Kingdom, LS7 4SA
    • Leeds Teaching Hospitals NHS Trust
  • Liverpool, United Kingdom, L9 7AL
    • University Hospital Aintree
  • London, United Kingdom, TW7 6AF
    • West Middlesex University Hospital
  • Peterborough, United Kingdom, PE3 9GZ
    • Peterborough City Hospital
  • Swindon, United Kingdom, SN3 6BB
    • Great Western Hospital
• United States
  • California
    • Chula Vista, California, United States, 91910
      • Advanced Clinical Research Center
    • Fullerton, California, United States, 92835
      • Providence Medical Foundation
    • La Palma, California, United States, 90623
      • Arthritis & Osteoporosis Medical Center - La Palma
    • Monterey Park, California, United States, 91754
      • NovaMed Research
    • San Leandro, California, United States, 94578
      • Medvin Clinical Research San Leandro
    • Santa Monica, California, United States, 90404
      • Providence Saint John s Health Center
    • Tustin, California, United States, 92780
      • Solace Clinical Research California
    • Upland, California, United States, 91786
      • Inland Rheumatology Clinical Trials Inc.
  • Colorado
    • Denver, Colorado, United States, 80230
      • Denver Arthritis Clinic
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida Inc
    • Jacksonville, Florida, United States, 32256
      • UF Health Rheumatology
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research
    • Sarasota, Florida, United States, 34239
      • Sarasota Arthritis Center
    • South Miami, Florida, United States, 33143
      • BioResearch Partner
  • Georgia
    • Suwanee, Georgia, United States, 30024
      • Immunology and Rheumatology Research Associates LLC
  • Illinois
    • Skokie, Illinois, United States, 60076
      • Clinical Investigation Specialists - Clinic of Robert Hozman
    • Willowbrook, Illinois, United States, 60527
      • Willow Rheumatology and Wellness PLLC
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital and Clinics
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Michigan
    • Saint Clair Shores, Michigan, United States, 48081
      • Clinical Research Institute of Michigan, LLC
  • Minnesota
    • Eagan, Minnesota, United States, 55123
      • St. Paul Rheumatology P A
  • Missouri
    • Kansas City, Missouri, United States, 64151
      • AARA Clinical Research- Kansas City Physicians Partners
  • New Jersey
    • Voorhees Township, New Jersey, United States, 08043
      • Arthritis Rheumatic And Back Disease Associates
  • New York
    • New York, New York, United States, 10016
      • Pioneer Clinical Research NY
    • New York, New York, United States, 10016
      • NYU Langone Health - Clinical and Translational Science Institute
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Joint and Muscle Research Institute
    • Charlotte, North Carolina, United States, 28211
      • Atrium Health SouthPark Rheumatology
    • Salisbury, North Carolina, United States, 28144
      • Onsite Clinical Solutions
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Wright State Physicians Health Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Rheumatology Associates of Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • OMRF Rheumatology Center of Excellence
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research Philadelphia
  • South Carolina
    • Summerville, South Carolina, United States, 29486
      • Low Country Rheumatology PA
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • West Tennessee Research Institute
    • Murfreesboro, Tennessee, United States, 37128
      • AARA Clinical Research - Murfreesboro Medical Clinic
  • Texas
    • Amarillo, Texas, United States, 79124
      • Amarillo Premier Research
    • Plano, Texas, United States, 75024
      • Texas Rheumatology Research Institute LLC
    • Sugar Land, Texas, United States, 77479
      • Fort Bend Rheumatology Associates PLLC
    • The Woodlands, Texas, United States, 77382
      • Advanced Rheumatology of Houston
  • Utah
    • Layton, Utah, United States, 84041
      • Alpine Research TC LLC
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Tidewater Clinical Research
  • Washington
    • Bellevue, Washington, United States, 98004
      • Overlake Arthritis and Osteoporosis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:-

• 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

Exclusion Criteria:

• Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Nipocalimab; Nipocalimab SC.; Other Names: JNJ-80202135, JNJ-86507083, M281; Drug: Standard of care treatment; Protocol-defined topical and systemic standard of care background treatments.
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.	Drug: Standard of care treatment; Protocol-defined topical and systemic standard of care background treatments.; Drug: Placebo; Placebo SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48	ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD. The ClinESSDAI includes 11 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain being measured. A higher score represents worse disease symptoms.	Baseline to Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48	The ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with Sjogren's syndrome.	Baseline to Week 48
Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline	ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.	Baseline to Week 48
Change from Baseline in ClinESSDAI Score at Week 8	ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.	Baseline to Week 8
Change from Baseline in Stimulated Salivary Flow Rate at Week 48	Stimulated salivary flow is considered a reliable and objective method to evaluate glandular function in SjD patients.	Baseline to Week 48
Change from Baseline in Sjogren's Symptoms Dryness Score at Week 48	Participants will be asked to report the worst severity of their dryness symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No [specific symptom]" and score 10 indicating "Severe [specific symptom]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren's Symptoms dryness score at Week 48 for US, US reference regions, and other non-US regions will be reported.	Baseline to Week 48
Change from Baseline in Sjogren's Symptoms Joint Pain Score at Week 48	Participants will be asked to report the worst severity of their joint pain symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No [specific symptom]" and score 10 indicating "Severe [specific symptom]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren's Symptoms joint pain score at Week 48 for US, US reference regions, and other non-US regions will be reported.	Baseline to Week 48
Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 48	FACIT-Fatigue version 4.0 is a 13-item questionnaire that assesses participant-reported fatigue and its impact upon daily activities and function over the past 7 days. Participants will be asked to answer each question using a 5-point Likert scale (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; and 4=Very much). FACIT-Fatigue has a total score range from 0 to 52, with 0 being the worst possible score and 52 the best.	Baseline to Week 48
Change from Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Score At Week 48	ESSPRI is a participant-reported assessment of the severity of dryness, fatigue, and pain associated with primary Sjogren's Syndrome. Participants are asked to rate the severity of dryness, fatigue, and pain on a 0 to 10 NRS, with score 0 indicating "No [specific symptom]" and score 10 indicating "Severe [specific symptom]". A global score, calculated as the mean of the 3 domain scores, ranges from 0 to 10, with higher scores reflecting greater (worse) symptom severity. Change from baseline in Sjogren's Symptoms score at Week 48 for EU, UK & EU reference regions will be reported.	Baseline to Week 48

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): May 18, 2029

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Sjogrens Disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Skin and Connective Tissue Diseases; Sjogren's Syndrome; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 80202135SJS3001 (Other Identifier: Janssen Research & Development, LLC); 2024-513965-38-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No