Actively Recruiting
A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
Led by Amgen · Updated on 2026-04-28
844
Participants Needed
174
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
CONDITIONS
Official Title
A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has provided informed consent before starting any study activities.
- Must have completed a phase 3 dazodalibep or placebo study for Sjögren's Syndrome through Week 48.
- Must be able to receive the first dose of this extension study within 28 days after Week 48 of the prior phase 3 study.
You will not qualify if you...
- Has a clinically significant active infection at Day 1 requiring antibiotics or antiviral medication.
- Plans to participate in another clinical study with investigational products or procedures during this study.
- Has any health condition or change reported during prior phase 3 studies that would interfere with safety evaluation or increase risk.
- Plans surgeries or hospitalizations that would interfere with safety evaluation.
- Plans to receive live (attenuated) vaccines during this study.
- Female participants of childbearing potential unwilling to use required contraception during and 12 weeks after treatment.
- Pregnant, lactating, or planning pregnancy during the study.
- Known sensitivity to any study products or components.
- Unlikely to complete all study visits or comply with study procedures.
- Has any other significant medical disorder posing safety risks or interfering with study evaluation as judged by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 174 locations
1
Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, United States, 85392
Actively Recruiting
2
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
Flagstaff, Arizona, United States, 86001-6269
Actively Recruiting
3
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
Gilbert, Arizona, United States, 85297-7336
Actively Recruiting
4
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
Glendale, Arizona, United States, 85306-9800
Actively Recruiting
5
Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
Tucson, Arizona, United States, 85704-1139
Actively Recruiting
6
Samy Metyas MD Inc
Covina, California, United States, 91723
Actively Recruiting
7
UCSD Altman Clinical and Translational Research Institute Building
La Jolla, California, United States, 92037-1337
Actively Recruiting
8
Tekton Research, LLC - 2121 E Harmony Rd - PPDS
Fort Collins, Colorado, United States, 80528-3400
Actively Recruiting
9
Bradenton Research Center Inc
Bradenton, Florida, United States, 34205-1704
Actively Recruiting
10
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, United States, 33765-2616
Actively Recruiting
11
BayCare Medical Group Primary Care and Rheumatology - Tampa
Tampa, Florida, United States, 33614-7101
Actively Recruiting
12
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111-1527
Actively Recruiting
13
Shores Rheumatology
Saint Clair Shores, Michigan, United States, 48081-1274
Actively Recruiting
14
Kansas City Physician Partners-8350 N Saint Clair Ave
Kansas City, Missouri, United States, 64151
Actively Recruiting
15
Arthritis, Rheumatic & Bone Disease Associates - Voorhees
Voorhees Township, New Jersey, United States, 08043-4501
Actively Recruiting
16
Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd
Charlotte, North Carolina, United States, 28207-1100
Actively Recruiting
17
Duke Early Phase Clinical Research Unit - PPDS
Durham, North Carolina, United States, 27710-0001
Actively Recruiting
18
Onsite Clinical Solutions, LLC - Salisbury
Salisbury, North Carolina, United States, 28144
Actively Recruiting
19
Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg
Miamisburg, Ohio, United States, 45342-3585
Actively Recruiting
20
University of Toledo Medical Center
Toledo, Ohio, United States, 43614-2595
Actively Recruiting
21
STAT Research-600 Aviator Ct
Vandalia, Ohio, United States, 45377-9474
Actively Recruiting
22
Murfreesboro Medical Clinic Westlawn
Murfreesboro, Tennessee, United States, 37128
Actively Recruiting
23
Accurate Clinical Management-Baytown
Baytown, Texas, United States, 77521-2279
Actively Recruiting
24
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, United States, 76034-5913
Actively Recruiting
25
R & H Clinical Research-777 S Fry Rd
Katy, Texas, United States, 77450-2297
Actively Recruiting
26
Houston Rheumatology & Arthritis Specialists - PLLC - PPDS
Katy, Texas, United States, 77494-1341
Actively Recruiting
27
Biopharma Informatic - Ridge Road - PPDS
McAllen, Texas, United States, 78503-1527
Actively Recruiting
28
Advanced Rheumatology of Houston
The Woodlands, Texas, United States, 77382-2935
Actively Recruiting
29
DM Clinical Research - Migraine and COPD - PPDS
Tomball, Texas, United States, 77375
Actively Recruiting
30
Western Washington Medical Group, Bothell - Rheumatology
Bothell, Washington, United States, 98021
Actively Recruiting
31
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, United States, 25801-2805
Actively Recruiting
32
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
Actively Recruiting
33
Instituto CER S.A.
Quilmes, Buenos Aires, Argentina, B1878DVB
Actively Recruiting
34
Instituto de Investigaciones Clinicas Quilmes SRL
Quilmes, Buenos Aires, Argentina, B1878GEG
Actively Recruiting
35
MR Medicina Reumatologica
San Fernando, Buenos Aires, Argentina, B1646GHP
Actively Recruiting
36
DOM Centro de Reumatología
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1111
Actively Recruiting
37
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
Actively Recruiting
38
Centro Medico Privado de Reumatologia - PPDS
San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
Actively Recruiting
39
Clínica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Tucumán Province, Argentina, T4000IHE
Actively Recruiting
40
Aprillus Asistencia e Investigacion - Terrada 89
Buenos Aires, Argentina, 1406
Actively Recruiting
41
Hospital General de Agudos Dr. José María Ramos Mejia
Buenos Aires, Argentina, C1121ADC
Actively Recruiting
42
Sanatorio Agote - Swiss Medical Group - PPDS
Buenos Aires, Argentina, C1425EOE
Actively Recruiting
43
Centro Medico Arsema
Buenos Aires, Argentina, C1427CCL
Actively Recruiting
44
Sanatorio Allende S.A.-Hipolito Yrigoyen 384
Córdoba, Argentina, X5000JHQ
Actively Recruiting
45
Framingham Centro Médico
La Plata, Argentina, B1902COS
Actively Recruiting
46
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
San Juan, Argentina, J5402DIL
Actively Recruiting
47
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Actively Recruiting
48
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
49
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
Salvador, Estado de Bahia, Brazil, 40150-150
Actively Recruiting
50
Centro de Estudos em Terapias Inovadoras
Curitiba, Paraná, Brazil, 80030-110
Actively Recruiting
51
LMK Servicos Medicos SS
Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
Actively Recruiting
52
Clinique de Rhumatologie Du Centre Du Quebec
Trois-Rivières, Quebec, Canada, G8Z 1Y2
Actively Recruiting
53
Centro de Investigacion de Enfermedades Respiratorias e inmunologicas
Viña del Mar, Valparaiso, Chile, 2520000
Actively Recruiting
54
Enroll SpA - Dr. Manuel Barros Borgono - PPDS
Providencia, Chile, 7500000
Actively Recruiting
55
BIOCINETIC Ltda
Santiago, Chile, 8350595
Actively Recruiting
56
Centro de especialidades médicas Vanguardia
Temuco, Chile, 4810345
Actively Recruiting
57
Clinical Research Chile SpA - PPDS
Valdivia, Chile, 5110683
Actively Recruiting
58
Polyclinic Bonifarm
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
59
University Hospital of Split
Split, Croatia, 21000
Actively Recruiting
60
CHU de Bordeaux - Hôpital Saint-André
Bordeaux, France, 33000
Actively Recruiting
61
CHU de Brest - Hôpital La Cavale Blanche
Brest, France, 29200
Actively Recruiting
62
GHRMSA - Hôpital Emile Muller
Mulhouse, France, 68100
Actively Recruiting
63
AP-HP - Hôpital Saint Antoine
Paris, France, 75012
Actively Recruiting
64
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Actively Recruiting
65
University Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
66
Rheumazentrum Prof. Dr. med. Gunther Neeck-Standort Bad Doberan
Bad Doberan, Mecklenburg-Vorpommern, Germany, 18209
Actively Recruiting
67
Rheumazentrum Greifswald
Greifswald Hansestadt, Mecklenburg-Vorpommern, Germany, 17493
Actively Recruiting
68
MVZ Rheuma
Hamburg, Germany, 20095
Actively Recruiting
69
Naval Hospital of Athens
Athens, Attica, Greece, 115 21
Actively Recruiting
70
Laiko General Hospital of Athens
Athens, Attica, Greece, 115 27
Actively Recruiting
71
University General Hospital of Larissa
Larissa, Larisa, Greece, 411 10
Actively Recruiting
72
Euromedica Kianous Stavros
Thessaloniki, Greece, 546 36
Actively Recruiting
73
Bekes Varmegyei Kozponti Korhaz
Gyula, Bekes County, Hungary, 5700
Actively Recruiting
74
Vasarhelyi Sarkanyfu Kft.
Hódmezovásárhely, Csongrád megye, Hungary, 6800
Actively Recruiting
75
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
Debrecen, Hajdú-Bihar, Hungary, 4032
Actively Recruiting
76
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7
Budapest, Hungary, 1097
Actively Recruiting
77
Meir Medical Center
Kafr Saba, Central District, Israel, 4428164
Actively Recruiting
78
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Tel Aviv, Israel, 5262100
Actively Recruiting
79
Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia
Udine, Friuli Venezia Giulia, Italy, 33100
Actively Recruiting
80
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome, Lazio, Italy, 00168
Actively Recruiting
81
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Lazio, Italy, 128
Actively Recruiting
82
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy, 20122
Actively Recruiting
83
A.O.U. Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy, 10126
Actively Recruiting
84
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, Veneto, Italy, 37126
Actively Recruiting
85
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa, Italy, 56126
Actively Recruiting
86
AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia, Italy, 42123
Actively Recruiting
87
Chubu Rosai Hospital
Nagoya-shi, Akita, Japan, 455-0018
Actively Recruiting
88
Japan Community Health Care Organization (JCHO) Chukyo Hospital
Nagoya-shi, Akita, Japan, 457-0866
Actively Recruiting
89
Daido Clinic
Nagoya, Akita, Japan, 457-8511
Actively Recruiting
90
Sapporo Medical University Hospital
Sapporo, Hokkaidô, Japan, 060-8543
Actively Recruiting
91
Hokkaido University Hospital
Sapporo, Hokkaidô, Japan, 060-8648
Actively Recruiting
92
Hospital of the University of Occupational and Environmental Health, Japan
Kita Kyushu-shi, Hukuoka, Japan, 807-8556
Actively Recruiting
93
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan, 305-8576
Actively Recruiting
94
Kanazawa Medical University Hospital
Kahoku, Ishikawa-ken, Japan, 920-0293
Actively Recruiting
95
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan, 920-8641
Actively Recruiting
96
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa, Japan, 245-8575
Actively Recruiting
97
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Kyôto, Japan, 602-8566
Actively Recruiting
98
Kyoto University Hospital
Kyoto, Kyôto, Japan, 606-8507
Actively Recruiting
99
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan, 852-8501
Actively Recruiting
100
Sasebo Chuo Hospital
Sasebo-Shi, Nagasaki, Japan, 857-1165
Actively Recruiting
101
Kurashiki Medical Clinic
Kurashiki-Shi, Okayama-ken, Japan, 710-0824
Actively Recruiting
102
Saitama Medical University Hospital
Iruma-Gun Moroyama-Machi, Saitama, Japan, 350-0451
Actively Recruiting
103
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan, 431-3192
Actively Recruiting
104
St. Luke's International Hospital
Chuo-Ku, Tokyo, Japan, 104-0044
Actively Recruiting
105
Nihon University Itabashi Hospital
Itabashi-Ku, Tokyo, Japan, 173-0032
Actively Recruiting
106
Tokyo Medical Center
Meguro-Ku, Tokyo, Japan, 152-0021
Actively Recruiting
107
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan, 160-8582
Actively Recruiting
108
Mediadvance Clinical S.A.P.I. de C.V.
Parques de San Felipe, Chihuahua, Mexico, 31203
Actively Recruiting
109
Centro de Investigación en Artritis y Osteoporosis - PPDS
Mexicali, Estado de Baja California, Mexico, 21200
Actively Recruiting
110
Centro de Estudios de Investigacion Basica Y Clinica SC
Guadalajara, Jalisco, Mexico, 44690
Actively Recruiting
111
Centro de Investigación y Tratamiento Reumatológico S.C
Mexico City, Mexico City, Mexico, 11850
Actively Recruiting
112
Cryptex Investigación Clínica, S.A. de C.V.
Mexico City, Mexico City, Mexico, 6100
Actively Recruiting
113
Clinstile, S.A. de C.V.
Mexico City, Mexico, 6700
Actively Recruiting
114
Unidad de Atención Medica e Investigación en Salud
Mérida, Mexico, 97000
Actively Recruiting
115
Consultorio de Reumatologia
México, Mexico, 7760
Actively Recruiting
116
Optimal Clinical Trials Ltd - PPDS
Auckland, North Island, New Zealand, 1003
Actively Recruiting
117
Health New Zealand - Te Whatu Ora - Waikato (Waikato Hospital)
Hamilton, New Zealand, 3240
Actively Recruiting
118
Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS
Papatoetoe, New Zealand, 2025
Actively Recruiting
119
Clinica San Antonio S.A.C
Trujillo, La Libertad, Peru, 13008
Actively Recruiting
120
Medicentro Biociencias Peru S.R.L.
Pueblo Libre, Lima region, Peru, 1508
Actively Recruiting
121
Hospital Militar Central Luis Arias Schereiber
Jesus Maria, Peru, 15001
Actively Recruiting
122
Instituto de Ginecologia y Reproduccion - PPDS
Santiago de Surco, Peru, 33
Actively Recruiting
123
Pratia Poznan - PPDS
Poznan, Greater Poland Voivodeship, Poland, 60-192
Actively Recruiting
124
Med-Polonia Sp. z o.o.
Poznan, Greater Poland Voivodeship, Poland, 60-693
Actively Recruiting
125
Malopolskie Centrum Kliniczne
Krakow, Lesser Poland Voivodeship, Poland, 30-149
Actively Recruiting
126
Centrum Medyczne Oporow
Wroclaw, Lower Silesian Voivodeship, Poland, 52-416
Actively Recruiting
127
ETG Lublin - PPDS
Lublin, Lublin Voivodeship, Poland, 20-412
Actively Recruiting
128
Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4
Lublin, Lublin Voivodeship, Poland, 20-607
Actively Recruiting
129
MICS Centrum Medyczne Warszawa, Wronia - MICS
Warsaw, Masovian Voivodeship, Poland, 00-874
Actively Recruiting
130
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, Masovian Voivodeship, Poland, 02-172
Actively Recruiting
131
Centrum Medyczne Reuma Park
Warsaw, Masovian Voivodeship, Poland, 02-665
Actively Recruiting
132
WIM-PIB, Centralny Szpital Kliniczny MON
Warsaw, Masovian Voivodeship, Poland, 04-141
Actively Recruiting
133
Centrum Medyczne K2J2 - Wołomin
Wołomin, Masovian Voivodeship, Poland, 05-200
Actively Recruiting
134
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.
Malbork, Pomeranian Voivodeship, Poland, 82-200
Actively Recruiting
135
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, Poland, 85-065
Actively Recruiting
136
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, Poland, 85-168
Actively Recruiting
137
Centrum Medyczne Pratia Katowice - PPDS
Katowice, Poland, 40-081
Actively Recruiting
138
Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
Krakow, Poland, 30-363
Actively Recruiting
139
Centrum Medyczne PROMED- Olszanska 5G
Krakow, Poland, 31-513
Actively Recruiting
140
FutureMeds - Lodz - PPDS
Lodz, Poland, 91-363
Actively Recruiting
141
Twoja Przychodnia PCM
Poznan, Poland, 60-324
Actively Recruiting
142
Prywatna Praktyka Lekarska Pawel Hrycaj
Poznan, Poland, 61-397
Actively Recruiting
143
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
Warsaw, Poland, 02-637
Actively Recruiting
144
ETG Warszawa - PPDS
Warsaw, Poland, 02-677
Actively Recruiting
145
FutureMeds - Targowek - PPDS
Warsaw, Poland, 03-291
Actively Recruiting
146
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213
Wroclaw, Poland, 50-556
Actively Recruiting
147
Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3
Wroclaw, Poland, 53-034
Actively Recruiting
148
FutureMeds - Wroclaw - PPDS
Wroclaw, Poland, 53-673
Actively Recruiting
149
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon, Lisbon District, Portugal, 1349-019
Actively Recruiting
150
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
Lisbon, Lisbon District, Portugal, 1649-035
Actively Recruiting
151
Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
Ponte de Lima, Portugal, 4990-150
Actively Recruiting
152
ULS de Gaia/Espinho, EPE - Unidade I
Vila Nova de Gaia, Portugal, 4434-502
Actively Recruiting
153
Military Medical Academy
Belgrade, Belgrade, Serbia, 11000
Actively Recruiting
154
Institute of Rheumatology - PPDS
Belgrade, Serbia, 11000
Actively Recruiting
155
Klinika za Alergologiju i Imunologiju
Belgrade, Serbia, 112108
Actively Recruiting
156
University Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Actively Recruiting
157
Clinical Centre of Vojvodina
Novi Sad, Serbia, 21000
Actively Recruiting
158
Special Hospital For Rheumatic Diseases Novi Sad
Novi Sad, Serbia, 21000
Actively Recruiting
159
University Clinical Centre Maribor
Maribor, Slovenia, 2000
Actively Recruiting
160
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 6591
Actively Recruiting
161
Fundacio Hospital de l'Esperit Sant
Santa Coloma de Gramenet, Barcelona, Spain, 08923
Actively Recruiting
162
C.H. Regional Reina Sofia - PPDS
Córdoba, Córdoba, Spain, 14004
Actively Recruiting
163
Hospital Universitario de Basurto
Bilbao, Vizcaya, Spain, 48013
Actively Recruiting
164
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
Actively Recruiting
165
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
166
Hospital Quironsalud Infanta Luisa
Seville, Spain, 41010
Actively Recruiting
167
Hospital Universitario de Valme
Seville, Spain, 41014
Actively Recruiting
168
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
169
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
170
Taipei Medical University Hospital - PPDS
Taipei, Taiwan, 11031
Actively Recruiting
171
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan, 33305
Actively Recruiting
172
Queen Alexandra Hospital
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Actively Recruiting
173
Chapel Allerton Hospital - PPDS
Leeds, United Kingdom, LS7 4SA
Actively Recruiting
174
Mile End Hospital - PPDS
London, United Kingdom, E1 4DG
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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