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)
2 other identifiers
interventional
655
28 countries
254
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2024
Longer than P75 for phase_3
254 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 4, 2024
CompletedFirst Submitted
Initial submission to the registry
December 18, 2024
CompletedFirst Posted
Study publicly available on registry
December 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 2, 2029
April 13, 2026
April 1, 2026
3.1 years
December 18, 2024
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Baseline to Week 48
Secondary Outcomes (8)
Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48
Baseline to Week 48
Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline
Baseline to Week 48
Change from Baseline in ClinESSDAI Score at Week 8
Baseline to Week 8
Change from Baseline in Stimulated Salivary Flow Rate at Week 48
Baseline to Week 48
Change from Baseline in Sjogren's Symptoms Dryness Score at Week 48
Baseline to Week 48
- +3 more secondary outcomes
Study Arms (2)
Nipocalimab
EXPERIMENTALParticipants 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.
Placebo
PLACEBO 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.
Interventions
Protocol-defined topical and systemic standard of care background treatments.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (254)
Advanced Clinical Research Center
Chula Vista, California, 91910, United States
Providence Medical Foundation
Fullerton, California, 92835, United States
Arthritis & Osteoporosis Medical Center - La Palma
La Palma, California, 90623, United States
NovaMed Research
Monterey Park, California, 91754, United States
Medvin Clinical Research San Leandro
San Leandro, California, 94578, United States
Providence Saint John s Health Center
Santa Monica, California, 90404, United States
Solace Clinical Research California
Tustin, California, 92780, United States
Inland Rheumatology Clinical Trials Inc.
Upland, California, 91786, United States
Denver Arthritis Clinic
Denver, Colorado, 80230, United States
Clinical Research of West Florida Inc
Clearwater, Florida, 33765, United States
UF Health Rheumatology
Jacksonville, Florida, 32256, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Sarasota Arthritis Center
Sarasota, Florida, 34239, United States
BioResearch Partner
South Miami, Florida, 33143, United States
Immunology and Rheumatology Research Associates LLC
Suwanee, Georgia, 30024, United States
Clinical Investigation Specialists - Clinic of Robert Hozman
Skokie, Illinois, 60076, United States
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, 60527, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Clinical Research Institute of Michigan, LLC
Saint Clair Shores, Michigan, 48081, United States
St. Paul Rheumatology P A
Eagan, Minnesota, 55123, United States
AARA Clinical Research- Kansas City Physicians Partners
Kansas City, Missouri, 64151, United States
Arthritis Rheumatic And Back Disease Associates
Voorhees Township, New Jersey, 08043, United States
NYU Langone Health - Clinical and Translational Science Institute
New York, New York, 10016, United States
Pioneer Clinical Research NY
New York, New York, 10016, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204, United States
Atrium Health SouthPark Rheumatology
Charlotte, North Carolina, 28211, United States
Onsite Clinical Solutions
Salisbury, North Carolina, 28144, United States
Wright State Physicians Health Center
Fairborn, Ohio, 45324, United States
OMRF Rheumatology Center of Excellence
Oklahoma City, Oklahoma, 73104, United States
Rheumatology Associates of Oklahoma
Oklahoma City, Oklahoma, 73116, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Clinical Research Philadelphia
Philadelphia, Pennsylvania, 19114, United States
Low Country Rheumatology PA
Summerville, South Carolina, 29486, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
AARA Clinical Research - Murfreesboro Medical Clinic
Murfreesboro, Tennessee, 37128, United States
Amarillo Premier Research
Amarillo, Texas, 79124, United States
Texas Rheumatology Research Institute LLC
Plano, Texas, 75024, United States
Fort Bend Rheumatology Associates PLLC
Sugar Land, Texas, 77479, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382, United States
Alpine Research TC LLC
Layton, Utah, 84041, United States
Tidewater Clinical Research
Chesapeake, Virginia, 23320, United States
Overlake Arthritis and Osteoporosis Center
Bellevue, Washington, 98004, United States
Instituto Medico De Alta Complejidad (IMAC)
Buenos Aires, B1643CRO, Argentina
Centro de Investigacion San Miguel CISM
Buenos Aires, B1663GJE, Argentina
Mautalen Salud e Investigacion
CABA, C1128AAF, Argentina
Centro Medico del Dr. Javier Gerardo Tartaglione
Cdad Autonoma de Buenos Aires, C1123AAO, Argentina
Centro de Investigacion en Enfermedades Reumaticas CIER
Ciudad de Buenos Aires, C1055, Argentina
Centro Medico Barrio Parque. Swiss Medical Group
Ciudad de Buenos Aires, C1414, Argentina
Cosultorios Reumatologógicos Pampa
Ciudad de Buenos Aires, C1428, Argentina
Cer Instituto Medico
Quilmes, B1878DVB, Argentina
MR Medicina Reumatologica
San Fernando, B1646GHP, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, T4000AXL, Argentina
Medizinische Universitaet Graz
Graz, 8036, Austria
SCRI CCCIT gem GmbH
Salzburg, 5020, Austria
LK Weinviertel Stockerau
Stockerau, 2000, Austria
Medizinische Universitaet Wien
Vienna, 1090, Austria
Wiener Gesundheitsverbund Klinik Hietzing
Vienna, 1130, Austria
Instituto D Or de Pesquisa e Ensino 1
Brasília, 70390 700, Brazil
Ceti - Centro de Estudos Em Terapias Inovadoras
Curitiba, 80030 110, Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, 90035 901, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
LMK Servicos Medicos S S
Porto Alegre, 90480 000, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Ribeirão Preto, 14048 900, Brazil
SER - Servicos Especializados em Reumatologia da Bahia
Salvador, 40150 150, Brazil
Instituto D Or de Pesquisa e Ensino
Salvador, 41253 190, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, 15090 000, Brazil
EBSERH Empresa de Servicos Hospitalares Hospital Samaritano
São Paulo, 01229 001, Brazil
CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
São Paulo, 04266 010, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, 05403 000, Brazil
CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda
Vitória, 29055 450, Brazil
UMHAT Kaspela
Plovdiv, 4001, Bulgaria
Medical Center Artmed
Plovdiv, 4002, Bulgaria
Medical Center Teodora
Rousse, 7003, Bulgaria
Lyulin Multi Profile Hospital For Active Medical Treatment
Sofia, 1336, Bulgaria
Diagnostic-Consultative Center (DCC) Aleksandrovska
Sofia, 1431, Bulgaria
St Ivan Rilski University Multiprofile Hospital For Active Treatment
Sofia, 1431, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment Sofia
Sofia, 1606, Bulgaria
Diagnostic Consultative Center - DCC Equita EOOD
Varna, 9000, Bulgaria
MHAT 'St. Marina' EAD
Varna, 9010, Bulgaria
Dr Sabeen Anwar Medicine Professional Corporation
Windsor, Ontario, N8X 1T3, Canada
Hospital Regional de Rimouski
Rimouski, Quebec, G5L 5T1, Canada
Centre de Recherche Musculo Squelettique
Trois-Rivières, Quebec, G9A 3X2, Canada
Beiijing Friendship Hospital, Capital Medical University
Beijing, 100050, China
Peking University Third Hospital
Beijing, 100191, China
Xiangya Hospital Central South University
Changsha, 410008, China
Changzhou No 2 Peoples Hospital
Changzhou, 213164, China
West China Hospital Sichuan University
Chengdu, 610041, China
Dazhou Central Hospital
Dazhou, 635002, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, 341006, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, 510275, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, 550004, China
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, 311608, China
Anhui Provincial Hospital
Hefei, 230001, China
Shandong Provincial Hospital
Jinan, 250021, China
Jinhua municipal central hospital
Jinhua, 321013, China
Linyi City People Hospital
Linyi, 276002, China
The First Affiliated Hospital of NanChang University
Nanchang, 330019, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, 637503, China
Zhongda Hospital Southeast University
Nanjing, 210009, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, 530000, China
Ningbo medical center lihuili hospital
Ningbo, 315041, China
Huashan Hospital affiliated to Fudan University
Shanghai, 200031, China
Shenshan Medical Center Memorial Hospital of Sun Yat Sen University
Shanwei, 516601, China
The Second Hospital of Hebei Medical University
Shijiazhuang, 050004, China
Shanxi Academy of Medical Sciences
Taiyuan, 030000, China
Tianjin First Central Hospital
Tianjin, 300384, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
The first affiliated hospital of xiamen university
Xiamen, 361003, China
Xinxiang Central Hospital
Xinxiang, 453099, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221000, China
People s Hospital of Ningxia Hui Autonomous Region
Yinchuan, 750031, China
Zhongshan Traditional Chinese Medicine Hospital
Zhongshan, 528401, China
Revmatologie s r o
Brno, 63800, Czechia
Revimex Pro s r o
Karvina Frystat, 73301, Czechia
Artroscan s r o
Ostrava, 722 00, Czechia
Nuselska Poliklinika
Prague, 140 00, Czechia
MEDICAL PLUS Research, s.r.o.
Uherské Hradiště, 68601, Czechia
Aarhus University Hospital
Aarhus, 8200, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Zealand University Hospital
Køge, 4600, Denmark
CHU de Brest - Hopital de la Cavale Blanche
Brest, 29200, France
CHU Dijon Bourgogne - Hopital Francois Mitterrand
Dijon, 21000, France
Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud
Le Kremlin-Bicêtre, 94270, France
CHRU de Lille Hopital Claude Huriez
Lille, 59037, France
CHRU Montpellier Hopital Lapeyronie
Montpellier, 34090, France
CHU Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, 42270, France
CHRU de Strasbourg - Hopital de Hautepierre
Strasbourg, 67200, France
CHU Bordeaux
Talence, 33400, France
Krankenhaus Porz am Rhein
Cologne, 51149, Germany
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Universitätsklinikum Erlangen Medizinische Klinik 3
Erlangen, 91054, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Hamburger Rheuma Forschungszentrum II
Hamburg, 20095, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Rheumazentrum Ruhrgebiet
Herne, 44649, Germany
Klinikum der Universitaet Muenchen
München, 80336, Germany
Medicover Muenchen Ost MVZ
München, 81667, Germany
Rheumazentrum Ratingen
Ratingen, 40878, Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97080, Germany
Queen Mary Hospital
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Semmelweis Egyetem Reumatologiai es Immunologiai Klinika
Budapest, 1023, Hungary
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
Budapest, 1027, Hungary
Clinexpert Kft
Budapest, 1033, Hungary
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
Budapest, 1097, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Szegedi Tudomanyegyetem
Szeged, 6725, Hungary
Vita Verum Medical Egeszsegugyi Szolgaltato Bt
Székesfehérvár, 8000, Hungary
Barzilai Medical Center
Ashkelon, 7830604, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Carmel Medical Center
Haifa, 34362, Israel
Tzafon Medical Center Poria
Har Poriyya, 1528001, Israel
Galil Medical Center
Nahariya, 2210001, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 5262100, Israel
Sourasky Medical Center
Tel Aviv, Israel
Ospedale San Raffaele
Milan, 20132, Italy
Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
Milan, 20122, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
Perugia, 06129, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Umberto I Policlinico di Roma
Roma, 00161, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168, Italy
Campus Bio Medico di Roma
Roma, 128, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Ospedale S. Maria Della Misericordia
Udine, 33100, Italy
St. Luke's International Hospital
Chūōku, 104 8560, Japan
Tokyo Metropolitan Tama Medical Center
Fuchū, 183 8524, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810 8563, Japan
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, 586 8521, Japan
Shinkenko Clinic
Naha, 900 0015, Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, 700 8557, Japan
Hokkaido University Hospital
Sapporo, 060 8648, Japan
Sasebo Chuo Hospital
Sasebo, 857 1195, Japan
Tohoku Medical And Pharmaceutical University Hospital
Sendai, 983 0005, Japan
Dokkyo Medical University Hospital
Shimotsuga Gun, 321 0293, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku, 130 8575, Japan
Nihon University Itabashi Hospital
Tokyo, 173 8610, Japan
Centro de Investigacion de Tratamientos Innovadores de Sinaloa
Culiacán, 80000, Mexico
Clinica de Investigacion en Reumatologia y Obesidad
Guadalajara, 44650, Mexico
Centro Medico Nacional Siglo XXI IMSS
Mexico City, 06720, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico D F, 14080, Mexico
Medical Care & Research SA de CV
Mérida, 97070, Mexico
CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V
México, 06700, Mexico
SMIQ S de R L de C V
Querétaro, 76070, Mexico
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi
San Luis Potosí City, 78213, Mexico
Medisch Spectrum Twente
Enschede, 7512 KZ, Netherlands
Oslo universitetssykehus HF, Rikshospitalet
Oslo, 0372, Norway
Stavanger University Hospital
Stavanger, 4011, Norway
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85 065, Poland
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85 168, Poland
ETG Debica
Dębica, 39 200, Poland
Malopolskie Badania Kliniczne Sp z o o
Krakow, 30-002, Poland
Futuremeds Krakow
Krakow, 31 501, Poland
ETG Lublin Poradnie Specjalistyczne
Lublin, 20 412, Poland
Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A
Olsztyn, 10 117, Poland
AI Centrum Medyczne
Poznan, 61 113, Poland
ETG Siedlce
Siedlce, 08 110, Poland
MICS Centrum Medyczne Warszawa
Warsaw, 00 874, Poland
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw, 02 637, Poland
FutureMeds Targowek
Warsaw, 03 291, Poland
Centrum Medyczne Oporow
Wroclaw, 52 416, Poland
FutureMeds Wroclaw
Wroclaw, 53 673, Poland
Ipr Inst Port de Reumatologia
Lisbon, 1050 034, Portugal
Uls Lisboa Ocidental - Hosp. Egas Moniz
Lisbon, 1349 019, Portugal
Uls Santa Maria - Hosp. Santa Maria
Lisbon, 1649 035, Portugal
Uls Gaia Espinho
Vila Nova de Gaia, 4434 502, Portugal
Spitalul Clinic Sf Maria
Bucharest, 011172, Romania
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Policlinica CCBR SRL
Bucharest, 030463, Romania
Hiperdia SA
Bucharest, 041312, Romania
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, 400006, Romania
Medisof Diagnostic S R L
Craiova, 200347, Romania
Selfmed Clinique S.R.L.
Timișoara, 300133, Romania
Chonnam National University Hospital
Gwangju, 61469, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Hanyang University Medical Center
Seoul, 04763, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
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
Ajou University Hospital
Suwon, 16499, South Korea
Hosp. Cima Sanitas Barcelona
Barcelona, 08034, Spain
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08041, Spain
Hosp. Gral. Juan Ramon Jimenez
Huelva, 21005, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. de Navarra
Pamplona, 310008, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Infanta Luisa
Seville, 41010, Spain
Universitatsspital Basel
Basel, 4031, Switzerland
Kantonsspital St Gallen
Sankt Gallen, 9000, Switzerland
NTU Biomedical Park Hospital
Hsinchu, 302058, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561, Taiwan
China Medical University Hospital
Taichung, 404332, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Gulhane Training and Research Hospital
Ankara, 06010, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, 06560, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 06800, Turkey (Türkiye)
Uludag University Medical Faculty
Bursa, 16059, Turkey (Türkiye)
Marmara University Istanbul Pendik Education and Research Hospital
Istanbul, 34899, Turkey (Türkiye)
Necmettin Erbakan University
Konya, 42090, Turkey (Türkiye)
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Doncaster Royal Infirmary
Doncaster, DN2 5LT, United Kingdom
Barts Health NHS Trust
Greater London, E1 4DG, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS7 4SA, United Kingdom
University Hospital Aintree
Liverpool, L9 7AL, United Kingdom
West Middlesex University Hospital
London, TW7 6AF, United Kingdom
Peterborough City Hospital
Peterborough, PE3 9GZ, United Kingdom
Great Western Hospital
Swindon, SN3 6BB, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2024
First Posted
December 19, 2024
Study Start
December 4, 2024
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
August 2, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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