AzTrials
AzTrials

Sjogrens SyndromePhase 3DAFFODILNCT06741969

Nipocalimab in Moderate to Severe Sjogren's Disease

A Phase 3 study testing Nipocalimab in people with Sjogrens Syndrome, run by Janssen Research & Development, LLC at 254 sites in 28 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sjogrens Syndrome
What is being tested?
Nipocalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
655 participants
Where
254 sitesin 28 countries
Study dates
4 Dec 2024to 18 May 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

254 sites in 28 countries.

254 sites in 28 countries

United States43 sites

  • Amarillo Medical Specialists LLP

    Amarillo, Texas, 79124

  • Overlake Arthritis and Osteoporosis Center

    Bellevue, Washington, 98004

  • Joint and Muscle Research Institute

    Charlotte, North Carolina, 28204

  • Atrium Health SouthPark Rheumatology

    Charlotte, North Carolina, 28211

  • Tidewater Clinical Research

    Chesapeake, Virginia, 23320

  • Advanced Clinical Research Center

    Chula Vista, California, 91910

  • Clinical Research of West Florida Inc

    Clearwater, Florida, 33765

  • Denver Arthritis Clinic

    Denver, Colorado, 80230

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • St. Paul Rheumatology P A

    Eagan, Minnesota, 55123

  • Wright State Physicians Health Center

    Fairborn, Ohio, 45324

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • UF Health Rheumatology

    Jacksonville, Florida, 32256

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • AARA Clinical Research- Kansas City Physicians Partners

    Kansas City, Missouri, 64151

  • Arthritis & Osteoporosis Medical Center - La Palma

    La Palma, California, 90623

  • Alpine Research TC LLC

    Layton, Utah, 84041

  • Providence Medical Foundation

    Mission Viejo, California, 92691

  • NovaMed Research

    Monterey Park, California, 91754

  • AARA Clinical Research - Murfreesboro Medical Clinic

    Murfreesboro, Tennessee, 37128

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • NYU Langone Health - Clinical and Translational Science Institute

    New York, New York, 10016

  • Pioneer Clinical Research NY

    New York, New York, 10016

  • OMRF Rheumatology Center of Excellence

    Oklahoma City, Oklahoma, 73104

  • Rheumatology Associates of Oklahoma

    Oklahoma City, Oklahoma, 73116

  • Clinical Research Philadelphia

    Philadelphia, Pennsylvania, 19114

  • Texas Rheumatology Research Institute LLC

    Plano, Texas, 75024

  • Clinical Research Institute of Michigan, LLC

    Saint Clair Shores, Michigan, 48081

  • Onsite Clinical Solutions

    Salisbury, North Carolina, 28144

  • Medvin Clinical Research San Leandro

    San Leandro, California, 94578

  • Providence Saint John s Health Center

    Santa Monica, California, 90404

  • Sarasota Arthritis Center

    Sarasota, Florida, 34239

  • Clinical Investigation Specialists - Clinic of Robert Hozman

    Skokie, Illinois, 60076

  • BioResearch Partner

    South Miami, Florida, 33143

  • Fort Bend Rheumatology Associates PLLC

    Sugar Land, Texas, 77479

  • Low Country Rheumatology PA

    Summerville, South Carolina, 29486

  • Immunology and Rheumatology Research Associates LLC

    Suwanee, Georgia, 30024

  • Advanced Rheumatology of Houston

    The Woodlands, Texas, 77382

  • Solace Clinical Research California

    Tustin, California, 92780

  • Inland Rheumatology Clinical Trials Inc.

    Upland, California, 91786

  • Arthritis Rheumatic And Back Disease Associates

    Voorhees Township, New Jersey, 08043

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois, 60527

Other trials in United States

China30 sites

  • Beiijing Friendship Hospital, Capital Medical University

    Beijing, 100050

  • Peking University Third Hospital

    Beijing, 100191

  • Xiangya Hospital Central South University

    Changsha, 410008

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213164

  • West China Hospital Sichuan University

    Chengdu, 610041

  • Dazhou Central Hospital

    Dazhou, 635002

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, 341006

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

    Guangzhou, 510275

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, 550004

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    Hangzhou, 311608

  • Anhui Provincial Hospital

    Hefei, 230001

  • Shandong Provincial Hospital

    Jinan, 250021

  • Jinhua municipal central hospital

    Jinhua, 321013

  • Linyi City People Hospital

    Linyi, 276002

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330019

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, 637503

  • Zhongda Hospital Southeast University

    Nanjing, 210009

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, 530000

  • Ningbo medical center lihuili hospital

    Ningbo, 315041

  • Huashan Hospital affiliated to Fudan University

    Shanghai, 200031

  • Shenshan Medical Center Memorial Hospital of Sun Yat Sen University

    Shanwei, 516601

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, 050004

  • Shanxi Academy of Medical Sciences

    Taiyuan, 030000

  • Tianjin First Central Hospital

    Tianjin, 300384

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • The first affiliated hospital of xiamen university

    Xiamen, 361003

  • Xinxiang Central Hospital

    Xinxiang, 453099

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, 221000

  • People s Hospital of Ningxia Hui Autonomous Region

    Yinchuan, 750031

  • Zhongshan Traditional Chinese Medicine Hospital

    Zhongshan, 528401

Other trials in China

Poland14 sites

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85 065

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85 168

  • ETG Debica

    Dębica, 39 200

  • Malopolskie Badania Kliniczne Sp z o o

    Krakow, 30-002

  • Futuremeds Krakow

    Krakow, 31 501

  • ETG Lublin Poradnie Specjalistyczne

    Lublin, 20 412

  • Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A

    Olsztyn, 10 117

  • AI Centrum Medyczne

    Poznan, 61 113

  • ETG Siedlce

    Siedlce, 08 110

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00 874

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

    Warsaw, 02 637

  • FutureMeds Targowek

    Warsaw, 03 291

  • Centrum Medyczne Oporow

    Wroclaw, 52 416

  • FutureMeds Wroclaw

    Wroclaw, 53 673

Other trials in Poland

Brazil13 sites

  • Instituto D Or de Pesquisa e Ensino 1

    Brasília, 70390 700

  • Ceti - Centro de Estudos Em Terapias Inovadoras

    Curitiba, 80030 110

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035 903

  • Hospital Moinhos de Vento

    Porto Alegre, 90035-001

  • LMK Servicos Medicos S S

    Porto Alegre, 90480 000

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

    Ribeirão Preto, 14048 900

  • SER - Servicos Especializados em Reumatologia da Bahia

    Salvador, 40150 150

  • IDOR - Regional Bahia

    Salvador, 41253-190

  • Funfarme Sjrp

    São José do Rio Preto, 15090-000

  • Hospital Samaritano de Sao Paulo

    São Paulo, 01243 020

  • CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos

    São Paulo, 04266 010

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403 000

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

    Vitória, 29055 450

Other trials in Brazil

Japan12 sites

  • St. Luke's International Hospital

    Chūōku, 104 8560

  • Tokyo Metropolitan Tama Medical Center

    Fuchū, 183 8524

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810 8563

  • National Hospital Organization Osaka Minami Medical Center

    Kawachi-Nagano, 586 8521

  • Shinkenko Clinic

    Naha, 900 0015

  • Okayama City General Medical Center Okayama City Hospital

    Okayama, 700 8557

  • Hokkaido University Hospital

    Sapporo, 060 8648

  • Sasebo Chuo Hospital

    Sasebo, 857 1195

  • Tohoku Medical And Pharmaceutical University Hospital

    Sendai, 983 0005

  • Dokkyo Medical University Hospital

    Shimotsuga Gun, 321 0293

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida Ku, 130 8575

  • Nihon University Itabashi Hospital

    Tokyo, 173 8610

Other trials in Japan

Germany11 sites

  • Krankenhaus Porz am Rhein

    Cologne, 51149

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitatsklinikum Erlangen Medizinische Klinik 3

    Erlangen, 91054

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Hamburger Rheuma Forschungszentrum II

    Hamburg, 20095

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Rheumazentrum Ruhrgebiet

    Herne, 44649

  • Klinikum der Universitaet Muenchen

    München, 80336

  • Medicover Muenchen Ost MVZ

    München, 81667

  • Rheumazentrum Ratingen

    Ratingen, 40878

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080

Other trials in Germany

Argentina10 sites

  • Instituto Medico De Alta Complejidad (IMAC)

    Buenos Aires, B1643CRO

  • Centro de Investigacion San Miguel CISM

    Buenos Aires, B1663GJE

  • Mautalen Salud e Investigacion

    CABA, C1128AAF

  • Centro Medico del Dr. Javier Gerardo Tartaglione

    Cdad Autonoma de Buenos Aires, C1123AAO

  • Centro de Investigacion en Enfermedades Reumaticas CIER

    Ciudad de Buenos Aires, C1055

  • Centro Medico Barrio Parque. Swiss Medical Group

    Ciudad de Buenos Aires, C1414

  • Cosultorios Reumatologógicos Pampa

    Ciudad de Buenos Aires, C1428

  • Cer Instituto Medico

    Quilmes, B1878DVB

  • MR Medicina Reumatologica

    San Fernando, B1646GHP

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Italy10 sites

  • Ospedale San Raffaele

    Milan, 20132

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO

    Milan, 20122

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

  • Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia

    Perugia, 06129

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Umberto I Policlinico di Roma

    Roma, 00161

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

  • Campus Bio Medico di Roma

    Roma, 128

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • Ospedale S. Maria Della Misericordia

    Udine, 33100

Other trials in Italy

Bulgaria9 sites

  • UMHAT Kaspela

    Plovdiv, 4001

  • Medical Center Artmed

    Plovdiv, 4002

  • Medical Center Teodora

    Rousse, 7003

  • Lyulin Multi Profile Hospital For Active Medical Treatment

    Sofia, 1336

  • Diagnostic-Consultative Center (DCC) Aleksandrovska

    Sofia, 1431

  • St Ivan Rilski University Multiprofile Hospital For Active Treatment

    Sofia, 1431

  • Military Medical Academy Multiprofile Hospital for Active Treatment Sofia

    Sofia, 1606

  • Diagnostic Consultative Center - DCC Equita EOOD

    Varna, 9000

  • MHAT 'St. Marina' EAD

    Varna, 9010

Other trials in Bulgaria

France8 sites

  • CHU de Brest - Hopital de la Cavale Blanche

    Brest, 29200

  • CHU Dijon Bourgogne - Hopital Francois Mitterrand

    Dijon, 21000

  • Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud

    Le Kremlin-Bicêtre, 94270

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59037

  • CHRU Montpellier Hopital Lapeyronie

    Montpellier, 34090

  • CHU Saint Etienne Hopital Nord

    Saint-Priest-en-Jarez, 42270

  • CHRU de Strasbourg - Hopital de Hautepierre

    Strasbourg, 67200

  • CHU Bordeaux

    Talence, 33400

Other trials in France

Israel8 sites

  • Barzilai Medical Center

    Ashkelon, 7830604

  • Rambam Health Care Campus

    Haifa, 3109601

  • Carmel Medical Center

    Haifa, 34362

  • Tzafon Medical Center Poria

    Har Poriyya, 1528001

  • Galil Medical Center

    Nahariya, 2210001

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan, 5262100

  • Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Mexico8 sites

  • Centro de Investigacion de Tratamientos Innovadores de Sinaloa

    Culiacán, 80000

  • Clinica de Investigacion en Reumatologia y Obesidad

    Guadalajara, 44650

  • Medical Care & Research SA de CV

    Mérida, 97070

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

    México, 06700

  • Centro Medico Nacional Siglo XXI IMSS

    Mexico City, 06720

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico D F, 14080

  • SMIQ S de R L de C V

    Querétaro, 76070

  • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi

    San Luis Potosí City, 78213

Other trials in Mexico

South Korea8 sites

  • Chonnam National University Hospital

    Gwangju, 61469

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Hanyang University Medical Center

    Seoul, 04763

  • Konkuk University Medical Center

    Seoul, 05030

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591

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

    Suwon, 16247

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Spain8 sites

  • Hosp. Cima Sanitas Barcelona

    Barcelona, 08034

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08041

  • Hosp. Gral. Juan Ramon Jimenez

    Huelva, 21005

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. de Navarra

    Pamplona, 310008

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Infanta Luisa

    Seville, 41010

Other trials in Spain

United Kingdom8 sites

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • Doncaster Royal Infirmary

    Doncaster, DN2 5LT

  • Barts Health NHS Trust

    Greater London, E1 4DG

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS7 4SA

  • University Hospital Aintree

    Liverpool, L9 7AL

  • West Middlesex University Hospital

    London, TW7 6AF

  • Peterborough City Hospital

    Peterborough, PE3 9GZ

  • Great Western Hospital

    Swindon, SN3 6BB

Other trials in United Kingdom

Hungary7 sites

  • Semmelweis Egyetem Reumatologiai es Immunologiai Klinika

    Budapest, 1023

  • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

    Budapest, 1027

  • Clinexpert Kft

    Budapest, 1033

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

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Szegedi Tudomanyegyetem

    Szeged, 6725

  • Vita Verum Medical Egeszsegugyi Szolgaltato Bt

    Székesfehérvár, 8000

Other trials in Hungary

Romania7 sites

  • Spitalul Clinic Sf Maria

    Bucharest, 011172

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Policlinica CCBR SRL

    Bucharest, 030463

  • Hiperdia SA

    Bucharest, 041312

  • Spitalul Clinic Judetean de Urgenta Cluj

    Cluj-Napoca, 400006

  • Medisof Diagnostic S R L

    Craiova, 200347

  • Selfmed Clinique S.R.L.

    Timișoara, 300133

Other trials in Romania

Taiwan7 sites

  • NTU Biomedical Park Hospital

    Hsinchu, 302058

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561

  • China Medical University Hospital

    Taichung, 404332

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

Turkey (Türkiye)6 sites

  • Gulhane Training and Research Hospital

    Ankara, 06010

  • Gazi University Medical Faculty

    Ankara, 06560

  • Ankara Bilkent City Hospital

    Ankara, 06800

  • Uludag University Medical Faculty

    Bursa, 16059

  • Marmara University Istanbul Pendik Education and Research Hospital

    Istanbul, 34899

  • Necmettin Erbakan University

    Konya, 42090

Other trials in Turkey (Türkiye)

Austria5 sites

  • Medizinische Universitaet Graz

    Graz, 8036

  • SCRI CCCIT gem GmbH

    Salzburg, 5020

  • LK Weinviertel Stockerau

    Stockerau, 2000

  • Medizinische Universitaet Wien

    Vienna, 1090

  • Wiener Gesundheitsverbund Klinik Hietzing

    Vienna, 1130

Other trials in Austria

Czechia5 sites

  • Revmatologie s r o

    Brno, 63800

  • Revimex Pro s r o

    Karvina Frystat, 73301

  • Artroscan s r o

    Ostrava, 722 00

  • Nuselska Poliklinika

    Prague, 140 00

  • MEDICAL PLUS Research, s.r.o.

    Uherské Hradiště, 68601

Other trials in Czechia

Portugal4 sites

  • Ipr Inst Port de Reumatologia

    Lisbon, 1050 034

  • Uls Lisboa Ocidental - Hosp. Egas Moniz

    Lisbon, 1349 019

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon, 1649 035

  • Uls Gaia Espinho

    Vila Nova de Gaia, 4434 502

Other trials in Portugal

Canada3 sites

  • Hospital Regional de Rimouski

    Rimouski, Quebec, G5L 5T1

  • Centre de Recherche Musculo Squelettique

    Trois-Rivières, Quebec, G9A 3X2

  • Dr Sabeen Anwar Medicine Professional Corporation

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Denmark3 sites

  • Aarhus University Hospital

    Aarhus, 8200

  • Rigshospitalet

    Copenhagen, 2100

  • Zealand University Hospital

    Køge, 4600

Other trials in Denmark

Hong Kong2 sites

  • Queen Mary Hospital

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

Other trials in Hong Kong

Norway2 sites

  • Oslo universitetssykehus HF, Rikshospitalet

    Oslo, 0372

  • Stavanger University Hospital

    Stavanger, 4011

Other trials in Norway

Switzerland2 sites

  • Universitatsspital Basel

    Basel, 4031

  • Kantonsspital St Gallen

    Sankt Gallen, 9000

Other trials in Switzerland

Netherlands1 site

  • Medisch Spectrum Twente

    Enschede, 7512 KZ

Other trials in Netherlands

About this study

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)

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).

Read the 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.

Being tested
Nipocalimab, Placebo, Standard of care treatment
Keywords
Sjogrens Disease
Medical subject headings
Sjogren's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NipocalimabDrug

    Also called JNJ-80202135, JNJ-86507083, M281

    Nipocalimab SC.

  • PlaceboDrug

    Placebo SC.

  • Standard of care treatmentDrug

    Protocol-defined topical and systemic standard of care background treatments.

Study groups in NCT06741969
Study groupRoleWhat they receive
NipocalimabExperimentalParticipants 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.
Receives: Drug: Nipocalimab; Drug: Standard of care treatment
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo; Drug: Standard of care treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Week 48

Secondary outcomes (8)

  1. 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.

    Measured: Baseline to Week 48

  2. 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.

    Measured: Baseline to Week 48

  3. 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.

    Measured: Baseline to Week 8

  4. 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.

    Measured: Baseline to Week 48

  5. 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.

    Measured: Baseline to Week 48

  6. 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.

    Measured: Baseline to Week 48

  7. 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.

    Measured: Baseline to Week 48

  8. 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.

    Measured: Baseline to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2024
  2. Study start4 Dec 2024
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion18 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to one of the 2 identical studies (conducted under this single protocol) to make a total of 300 participants in each study. Participants in each study will be randomly assigned to one of the arms nipocalimab or placebo respectively.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
655 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06741969
Sponsor's protocol ID
80202135SJS3001
Other IDs
80202135SJS3001, 2024-513965-38-00
Acronym
DAFFODIL
Status last verified
Nov 2026
First submitted
18 Dec 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nipocalimab in people with Sjogrens Syndrome, run by Janssen Research & Development, LLC at 254 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 254 sites in United States, China, Poland, Brazil, Japan and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48 (time frame: Baseline to Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06741969.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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