Nipocalimab in Moderate to Severe Sjogren's Disease (DAFFODIL)
Last Updated May 14, 2025
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80202135SJS3001
OVERVIEW
-
Sexes Eligible for Study
all -
Age
years -
Phase
phase 3 -
Sites
Sites -
Status
Recruiting
SUMMARY
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.
CONDITIONS
- Sjogrens Syndrome
ELIGIBILITY
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/Euro
DETAILS
LOCATIONS
Locations in:
United States, Japan, Taiwan, United Kingdom, Argentina, Brazil, South Korea, Mexico
| Country (8) | City or Province (56) | Status |
| United States | Upland Inland Rheumatology Clinical Trials Inc. |
RECRUITING
|
| United States | Skokie Clinical Investigation Specialists - Clinic of Robert Hozman |
RECRUITING
|
| United States | Duncansville Altoona Center For Clinical Research |
RECRUITING
|
| United States | Denver Denver Arthritis Clinic |
RECRUITING
|
| United States | New Port Richey Suncoast Clinical Research |
RECRUITING
|
| United States | South Miami BioResearch Partner |
RECRUITING
|
| United States | Eagan St. Paul Rheumatology P A |
RECRUITING
|
| United States | Salisbury Onsite Clinical Solutions |
RECRUITING
|
| United States | Jackson West Tennessee Research Institute |
RECRUITING
|
| Japan | Chuo ku St. Luke's International Hospital |
RECRUITING
|
| Japan | Fukuoka National Hospital Organization Kyushu Medical Center |
RECRUITING
|
| Japan | Kawachi Nagano National Hospital Organization Osaka Minami Medical Center |
RECRUITING
|
| Japan | Naha Shinkenko Clinic |
RECRUITING
|
| Japan | Sasebo Sasebo Chuo Hospital |
RECRUITING
|
| Japan | Sendai Tohoku Medical And Pharmaceutical University Hospital |
RECRUITING
|
| Japan | Sumida ku Tokyo Metropolitan Bokutoh Hospital |
RECRUITING
|
| Taiwan | Kaohsiung City Kaohsiung Chang Gung Memorial Hospital |
RECRUITING
|
| Taiwan | Taipei Taipei Veterans General Hospital |
RECRUITING
|
| Taiwan | Taoyuan Linkou Chang Gung Memorial Hospital |
RECRUITING
|
| United Kingdom | Swindon Great Western Hospital |
RECRUITING
|
| United States | Fullerton Providence Medical Foundation |
RECRUITING
|
| United States | Clearwater Clinical Research of West Florida Inc |
RECRUITING
|
| United States | Sarasota Sarasota Arthritis Center |
RECRUITING
|
| United States | Charlotte Atrium Health SouthPark Rheumatology |
RECRUITING
|
| United States | Fairborn Wright State Physicians Health Center |
RECRUITING
|
| United States | Bellevue Overlake Arthritis and Osteoporosis Center |
RECRUITING
|
| Argentina | Buenos Aires Instituto Medico De Alta Complejidad (IMAC) |
RECRUITING
|
| Argentina | Ciudad de Buenos Aires Centro de Investigacion en Enfermedades Reumaticas CIER |
RECRUITING
|
| Argentina | Ciudad de Buenos Aires Centro Medico Barrio Parque. Swiss Medical Group |
RECRUITING
|
| Argentina | Ciudad de Buenos Aires Cosultorios Reumatologógicos Pampa |
RECRUITING
|
| Argentina | San Miguel De Tucuman Centro de Investigaciones Medicas Tucuman |
RECRUITING
|
| Brazil | Curitiba Ceti - Centro de Estudos Em Terapias Inovadoras |
RECRUITING
|
| Brazil | Sao Jose do Rio Preto Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base |
RECRUITING
|
| Brazil | Sao Paulo EBSERH Empresa de Servicos Hospitalares Hospital Samaritano |
RECRUITING
|
| Brazil | Sao Paulo CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos |
RECRUITING
|
| Brazil | Vitoria CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda |
RECRUITING
|
| Japan | Fuchu Tokyo Metropolitan Tama Medical Center |
RECRUITING
|
| Japan | Okayama Okayama City General Medical Center Okayama City Hospital |
RECRUITING
|
| Japan | Sapporo Hokkaido University Hospital |
RECRUITING
|
| Japan | Shimotsuga Gun Dokkyo Medical University Hospital |
RECRUITING
|
| Japan | Tokyo Nihon University Itabashi Hospital |
RECRUITING
|
| South Korea | Gwangju Chonnam National University Hospital |
RECRUITING
|
| South Korea | Seoul Hanyang University Medical Center |
RECRUITING
|
| South Korea | Seoul Konkuk University Medical Center |
RECRUITING
|
| South Korea | Seoul The Catholic University of Korea Seoul St Mary s Hospital |
RECRUITING
|
| South Korea | Suwon si Ajou University Hospital |
RECRUITING
|
| Mexico | Culiacan Centro de Investigacion de Tratamientos Innovadores de Sinaloa |
RECRUITING
|
| Mexico | Guadalajara Clinica de Investigacion en Reumatologia y Obesidad |
RECRUITING
|
| Mexico | Merida Medical Care & Research SA de CV |
RECRUITING
|
| Mexico | Mexico CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V |
RECRUITING
|
| Mexico | Queretaro SMIQ S de R L de C V |
RECRUITING
|
| Taiwan | Hsinchu City NTU Biomedical Park Hospital |
RECRUITING
|
| United Kingdom | Doncaster Doncaster Royal Infirmary |
RECRUITING
|
| United Kingdom | Greater London Barts Health NHS Trust |
RECRUITING
|
| United Kingdom | Liverpool University Hospital Aintree |
RECRUITING
|
| United Kingdom | Peterborough Peterborough City Hospital |
RECRUITING
|
Geo Locations
34.09751, -117.64839
42.03336, -87.73339
40.42341, -78.4339
39.73915, -104.9847
28.24418, -82.71927
25.7076, -80.29338
44.80413, -93.16689
35.67097, -80.47423
35.61452, -88.81395
35.57779, 139.71685
33.6, 130.41667
34.44108, 135.58283
26.21667, 127.68333
33.16832, 129.72501
38.26667, 140.86667
35.6948198, 139.8185403
22.61626, 120.31333
25.04776, 121.53185
24.95233, 121.20193
51.55797, -1.78116
33.87029, -117.92534
27.96585, -82.8001
27.33643, -82.53065
35.22709, -80.84313
39.82089, -84.01938
47.61038, -122.20068
-34.61315, -58.37723
-34.61315, -58.37723
-34.61315, -58.37723
-34.61315, -58.37723
-26.82414, -65.2226
-25.42778, -49.27306
-20.81972, -49.37944
-23.5475, -46.63611
-23.5475, -46.63611
-20.31944, -40.33778
35.6916009, 139.4620918
34.65, 133.93333
43.06667, 141.35
36.4729244, 139.8232641
35.6895, 139.69171
35.15472, 126.91556
37.566, 126.9784
37.566, 126.9784
37.566, 126.9784
37.29111, 127.00889
24.79032, -107.38782
20.66682, -103.39182
20.97537, -89.61696
19.42847, -99.12766
20.5734792, -100.382075
24.8138287, 120.9674798
53.52285, -1.13116
51.5250491, -0.0421792
53.41058, -2.97794
52.57364, -0.24777
x
50
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10
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5
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Corresponds to individual site.