A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
April 27, 2026 updated by: Amgen
A Multicenter, Open-Label, Long-term, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With Sjögren's Syndrome (SS)
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
Study Overview
Status
Status
Recruiting
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Interventional
Enrollment (Estimated)
Enrollment
844
Phase
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
Study Contact
- Name: Amgen Call Center
- Phone Number: 866-572-6436
- Email: medinfo@amgen.com
Study Locations
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Buenos Aires, Argentina, C1427CCL
- Recruiting
- Centro Medico Arsema
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Buenos Aires, Argentina, 1406
- Recruiting
- Aprillus Asistencia e Investigacion - Terrada 89
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Buenos Aires, Argentina, C1425EOE
- Recruiting
- Sanatorio Agote - Swiss Medical Group - PPDS
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Buenos Aires, Argentina, C1121ADC
- Recruiting
- Hospital General de Agudos Dr. José María Ramos Mejia
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Córdoba, Argentina, X5000JHQ
- Recruiting
- Sanatorio Allende S.A.-Hipolito Yrigoyen 384
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La Plata, Argentina, B1902COS
- Recruiting
- Framingham Centro Medico
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San Juan, Argentina, J5402DIL
- Recruiting
- Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
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Buenos Aires
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
- Recruiting
- Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
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Quilmes, Buenos Aires, Argentina, B1878GEG
- Recruiting
- Instituto de Investigaciones Clinicas Quilmes SRL
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Quilmes, Buenos Aires, Argentina, B1878DVB
- Recruiting
- Instituto CER S.A.
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San Fernando, Buenos Aires, Argentina, B1646GHP
- Recruiting
- MR Medicina Reumatologica
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Ciudad Autónoma de BuenosAires
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Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1111
- Recruiting
- DOM Centro de Reumatología
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
- Recruiting
- Centro Medico Privado de Reumatologia - PPDS
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San Miguel de Tucumán, Tucumán Province, Argentina, T4000IHE
- Recruiting
- Clínica Mayo de U.M.C.B. S.R.L
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San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
- Recruiting
- Centro de Investigaciones Reumatológicas
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South Australia
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Woodville South, South Australia, Australia, 5011
- Recruiting
- The Queen Elizabeth Hospital
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Ghent, Belgium, 9000
- Recruiting
- UZ Gent
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Estado de Bahia
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Salvador, Estado de Bahia, Brazil, 40150-150
- Recruiting
- SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
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Paraná
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Curitiba, Paraná, Brazil, 80030-110
- Recruiting
- Centro de Estudos em Terapias Inovadoras
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
- Recruiting
- LMK Servicos Medicos SS
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Quebec
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Trois-Rivières, Quebec, Canada, G8Z 1Y2
- Recruiting
- Clinique de Rhumatologie Du Centre Du Quebec
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Providencia, Chile, 7500000
- Recruiting
- Enroll SpA - Dr. Manuel Barros Borgono - PPDS
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Santiago, Chile, 8350595
- Recruiting
- BIOCINETIC Ltda
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Temuco, Chile, 4810345
- Recruiting
- Centro de especialidades médicas Vanguardia
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Valdivia, Chile, 5110683
- Recruiting
- Clinical Research Chile SpA - PPDS
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2520000
- Recruiting
- Centro de Investigacion de Enfermedades Respiratorias e Inmunologicas
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Split, Croatia, 21000
- Recruiting
- University Hospital of Split
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City of Zagreb
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Zagreb, City of Zagreb, Croatia, 10000
- Recruiting
- Polyclinic Bonifarm
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Bordeaux, France, 33000
- Recruiting
- CHU de Bordeaux - Hôpital Saint-André
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Brest, France, 29200
- Recruiting
- CHU de Brest - Hôpital La Cavale Blanche
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Mulhouse, France, 68100
- Recruiting
- GHRMSA - Hôpital Emile Muller
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Paris, France, 75012
- Recruiting
- AP-HP - Hôpital Saint Antoine
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Strasbourg, France, 67091
- Recruiting
- Hopitaux Universitaires de Strasbourg
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Hamburg, Germany, 20095
- Recruiting
- MVZ Rheuma
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Baden-Wurttemberg
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Heidelberg, Baden-Wurttemberg, Germany, 69120
- Recruiting
- University Clinic Heidelberg
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Mecklenburg-Vorpommern
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Bad Doberan, Mecklenburg-Vorpommern, Germany, 18209
- Recruiting
- Rheumazentrum Prof. Dr. med. Gunther Neeck-Standort Bad Doberan
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Greifswald Hansestadt, Mecklenburg-Vorpommern, Germany, 17493
- Recruiting
- Rheumazentrum Greifswald
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Thessaloniki, Greece, 546 36
- Recruiting
- Euromedica Kianous Stavros
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Attica
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Athens, Attica, Greece, 115 27
- Recruiting
- Laiko General Hospital of Athens
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Athens, Attica, Greece, 115 21
- Recruiting
- Naval Hospital of Athens
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Larisa
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Larissa, Larisa, Greece, 411 10
- Recruiting
- University General Hospital of Larissa
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Budapest, Hungary, 1097
- Recruiting
- Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7
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Bekes County
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Gyula, Bekes County, Hungary, 5700
- Recruiting
- Bekes Varmegyei Kozponti Korhaz
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Csongrád megye
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Hódmezovásárhely, Csongrád megye, Hungary, 6800
- Recruiting
- Vasarhelyi Sarkanyfu Kft.
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Hajdú-Bihar
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Debrecen, Hajdú-Bihar, Hungary, 4032
- Recruiting
- Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
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Central District
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Kafr Saba, Central District, Israel, 4428164
- Recruiting
- Meir Medical Center
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Tel Aviv
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Ramat Gan, Tel Aviv, Israel, 5262100
- Recruiting
- The Chaim Sheba Medical Center - PPDS
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Pisa, Italy, 56126
- Recruiting
- Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
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Reggio Emilia, Italy, 42123
- Recruiting
- AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova
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Friuli Venezia Giulia
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Udine, Friuli Venezia Giulia, Italy, 33100
- Recruiting
- Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia
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Lazio
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Rome, Lazio, Italy, 00168
- Recruiting
- Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
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Rome, Lazio, Italy, 128
- Recruiting
- Fondazione Policlinico Universitario Campus Bio-Medico
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Lombardy
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Milan, Lombardy, Italy, 20122
- Recruiting
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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Piedmont
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Turin, Piedmont, Italy, 10126
- Recruiting
- A.O.U. Città della Salute e della Scienza di Torino
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Veneto
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Verona, Veneto, Italy, 37126
- Recruiting
- Azienda Ospedaliera Universitaria Integrata Di Verona
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Akita
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Nagoya, Akita, Japan, 457-8511
- Recruiting
- Daido Clinic
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Nagoya-shi, Akita, Japan, 455-0018
- Recruiting
- Chubu Rosai Hospital
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Nagoya-shi, Akita, Japan, 457-0866
- Recruiting
- Japan Community Health Care Organization (JCHO) Chukyo Hospital
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Hokkaidô
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Sapporo, Hokkaidô, Japan, 060-8648
- Recruiting
- Hokkaido University Hospital
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Sapporo, Hokkaidô, Japan, 060-8543
- Recruiting
- Sapporo Medical University Hospital
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Hukuoka
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Kita Kyushu-shi, Hukuoka, Japan, 807-8556
- Recruiting
- Hospital of the University of Occupational and Environmental Health, Japan
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Ibaraki
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Tsukuba, Ibaraki, Japan, 305-8576
- Recruiting
- University of Tsukuba Hospital
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Ishikawa-ken
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Kahoku, Ishikawa-ken, Japan, 920-0293
- Recruiting
- Kanazawa Medical University Hospital
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Kanazawa, Ishikawa-ken, Japan, 920-8641
- Recruiting
- Kanazawa University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japan, 245-8575
- Recruiting
- National Hospital Organization Yokohama Medical Center
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Kyôto
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Kyoto, Kyôto, Japan, 602-8566
- Recruiting
- University Hospital, Kyoto Prefectural University of Medicine
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Kyoto, Kyôto, Japan, 606-8507
- Recruiting
- Kyoto University Hospital
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Nagasaki
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Nagasaki, Nagasaki, Japan, 852-8501
- Recruiting
- Nagasaki University Hospital
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Sasebo-Shi, Nagasaki, Japan, 857-1165
- Recruiting
- Sasebo Chuo Hospital
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Okayama-ken
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Kurashiki-Shi, Okayama-ken, Japan, 710-0824
- Recruiting
- Kurashiki Medical Clinic
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Saitama
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Iruma-Gun Moroyama-Machi, Saitama, Japan, 350-0451
- Recruiting
- Saitama Medical University Hospital
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Shizuoka
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Hamamatsu, Shizuoka, Japan, 431-3192
- Recruiting
- Hamamatsu University Hospital
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Tokyo
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Chuo-Ku, Tokyo, Japan, 104-0044
- Recruiting
- St. Luke's International Hospital
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Itabashi-Ku, Tokyo, Japan, 173-0032
- Recruiting
- Nihon University Itabashi Hospital
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Meguro-Ku, Tokyo, Japan, 152-0021
- Recruiting
- Tokyo Medical Center
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Shinjuku-Ku, Tokyo, Japan, 160-8582
- Recruiting
- Keio University Hospital
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Mexico City, Mexico, 6700
- Recruiting
- Clinstile, S.A. de C.V.
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Mérida, Mexico, 97000
- Recruiting
- Unidad de Atención Médica e Investigación en Salud
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México, Mexico, 7760
- Recruiting
- Consultorio de Reumatologia
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Chihuahua
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Parques de San Felipe, Chihuahua, Mexico, 31203
- Recruiting
- Mediadvance Clinical S.A.P.I. de C.V.
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Estado de Baja California
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Mexicali, Estado de Baja California, Mexico, 21200
- Recruiting
- Centro de Investigación en Artritis y Osteoporosis - PPDS
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Jalisco
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Guadalajara, Jalisco, Mexico, 44690
- Recruiting
- Centro de Estudios de Investigacion Basica Y Clinica SC
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Mexico City
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Mexico City, Mexico City, Mexico, 11850
- Recruiting
- Centro de Investigación y Tratamiento Reumatológico S.C
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Mexico City, Mexico City, Mexico, 6100
- Recruiting
- Cryptex Investigación Clínica, S.A. de C.V.
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Hamilton, New Zealand, 3240
- Recruiting
- Health New Zealand - Te Whatu Ora - Waikato (Waikato Hospital)
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Papatoetoe, New Zealand, 2025
- Recruiting
- Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS
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North Island
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Auckland, North Island, New Zealand, 1003
- Recruiting
- Optimal Clinical Trials Ltd - PPDS
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Jesus Maria, Peru, 15001
- Recruiting
- Hospital Militar Central Luis Arias Schereiber
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Santiago de Surco, Peru, 33
- Recruiting
- Instituto de Ginecologia y Reproduccion - PPDS
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La Libertad
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Trujillo, La Libertad, Peru, 13008
- Recruiting
- Clinica San Antonio S.A.C
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Lima region
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Pueblo Libre, Lima region, Peru, 1508
- Recruiting
- Medicentro Biociencias Peru S.R.L.
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Bydgoszcz, Poland, 85-168
- Recruiting
- Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
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Bydgoszcz, Poland, 85-065
- Recruiting
- MICS Centrum Medyczne Bydgoszcz
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Katowice, Poland, 40-081
- Recruiting
- Centrum Medyczne Pratia Katowice - PPDS
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Krakow, Poland, 30-363
- Recruiting
- Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
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Krakow, Poland, 31-513
- Recruiting
- Centrum Medyczne PROMED- Olszanska 5G
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Lodz, Poland, 91-363
- Recruiting
- FutureMeds - Lodz - PPDS
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Poznan, Poland, 60-324
- Recruiting
- Twoja Przychodnia PCM
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Poznan, Poland, 61-397
- Recruiting
- Prywatna Praktyka Lekarska Pawel Hrycaj
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Warsaw, Poland, 02-637
- Recruiting
- Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
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Warsaw, Poland, 02-677
- Recruiting
- ETG Warszawa - PPDS
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Warsaw, Poland, 03-291
- Recruiting
- FutureMeds - Targowek - PPDS
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Wroclaw, Poland, 50-556
- Recruiting
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213
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Wroclaw, Poland, 53-673
- Recruiting
- FutureMeds - Wroclaw - PPDS
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Wroclaw, Poland, 53-034
- Recruiting
- Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Poland, 60-192
- Recruiting
- Pratia Poznan - PPDS
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Poznan, Greater Poland Voivodeship, Poland, 60-693
- Recruiting
- Med-Polonia Sp. z o.o.
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Poland, 30-149
- Recruiting
- Malopolskie Centrum Kliniczne
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Poland, 52-416
- Recruiting
- Centrum Medyczne Oporow
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Poland, 20-412
- Recruiting
- ETG Lublin - PPDS
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Lublin, Lublin Voivodeship, Poland, 20-607
- Recruiting
- Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Poland, 02-665
- Recruiting
- Centrum Medyczne Reuma Park
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Warsaw, Masovian Voivodeship, Poland, 02-172
- Recruiting
- MTZ Clinical Research Powered by PRATIA - PPDS
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Warsaw, Masovian Voivodeship, Poland, 04-141
- Recruiting
- WIM-PIB, Centralny Szpital Kliniczny MON
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Warsaw, Masovian Voivodeship, Poland, 00-874
- Recruiting
- MICS Centrum Medyczne Warszawa, Wronia - MICS
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Wołomin, Masovian Voivodeship, Poland, 05-200
- Recruiting
- Centrum Medyczne K2J2 - Wołomin
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Pomeranian Voivodeship
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Malbork, Pomeranian Voivodeship, Poland, 82-200
- Recruiting
- Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.
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Ponte de Lima, Portugal, 4990-150
- Recruiting
- Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
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Vila Nova de Gaia, Portugal, 4434-502
- Recruiting
- ULS de Gaia/Espinho, EPE - Unidade I
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Lisbon District
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Lisbon, Lisbon District, Portugal, 1349-019
- Recruiting
- ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
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Lisbon, Lisbon District, Portugal, 1649-035
- Recruiting
- ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
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Belgrade, Serbia, 11000
- Recruiting
- Institute of Rheumatology - PPDS
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Belgrade, Serbia, 112108
- Recruiting
- Klinika za Alergologiju i Imunologiju
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Kragujevac, Serbia, 34000
- Recruiting
- University Clinical Center Kragujevac
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Novi Sad, Serbia, 21000
- Recruiting
- Clinical Centre of Vojvodina
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Novi Sad, Serbia, 21000
- Recruiting
- Special Hospital For Rheumatic Diseases Novi Sad
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Belgrade
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Belgrade, Belgrade, Serbia, 11000
- Recruiting
- Military Medical Academy
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Maribor, Slovenia, 2000
- Recruiting
- University Clinical Centre Maribor
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, South Korea, 6591
- Recruiting
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Madrid, Spain, 28031
- Recruiting
- Hospital Universitario Infanta Leonor
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Madrid, Spain, 28041
- Recruiting
- Hospital Universitario 12 de Octubre
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Seville, Spain, 41014
- Recruiting
- Hospital Universitario de Valme
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Seville, Spain, 41010
- Recruiting
- Hospital Quironsalud Infanta Luisa
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Barcelona
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Santa Coloma de Gramenet, Barcelona, Spain, 08923
- Recruiting
- Fundacio Hospital de l'Esperit Sant
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Córdoba
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Córdoba, Córdoba, Spain, 14004
- Recruiting
- C.H. Regional Reina Sofia - PPDS
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Vizcaya
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Bilbao, Vizcaya, Spain, 48013
- Recruiting
- Hospital Universitario de Basurto
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Kaohsiung City, Taiwan, 80756
- Recruiting
- Kaohsiung Medical University - Chung-Ho Memorial Hospital
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Taichung, Taiwan, 40705
- Recruiting
- Taichung Veterans General Hospital
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Taipei, Taiwan, 11031
- Recruiting
- Taipei Medical University Hospital - PPDS
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Taoyuan District, Taiwan, 33305
- Recruiting
- Chang Gung Memorial Hospital, Linkou
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Leeds, United Kingdom, LS7 4SA
- Recruiting
- Chapel Allerton Hospital - PPDS
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London, United Kingdom, E1 4DG
- Recruiting
- Mile End Hospital - PPDS
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Hampshire
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Portsmouth, Hampshire, United Kingdom, PO6 3LY
- Recruiting
- Queen Alexandra Hospital
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Arizona
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Avondale, Arizona, United States, 85392
- Recruiting
- Arizona Arthritis & Rheumatology Associates - Avondale
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Flagstaff, Arizona, United States, 86001-6269
- Recruiting
- Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
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Gilbert, Arizona, United States, 85297-7336
- Recruiting
- Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
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Glendale, Arizona, United States, 85306-9800
- Recruiting
- Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
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Tucson, Arizona, United States, 85704-1139
- Recruiting
- Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
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California
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Covina, California, United States, 91723
- Recruiting
- Samy Metyas MD Inc
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La Jolla, California, United States, 92037-1337
- Recruiting
- UCSD Altman Clinical and Translational Research Institute Building
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Colorado
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Fort Collins, Colorado, United States, 80528-3400
- Recruiting
- Tekton Research, LLC - 2121 E Harmony Rd - PPDS
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Florida
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Bradenton, Florida, United States, 34205-1704
- Recruiting
- Bradenton Research Center Inc
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Clearwater, Florida, United States, 33765-2616
- Recruiting
- Clinical Research of West Florida Inc - Clearwater
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Tampa, Florida, United States, 33614-7101
- Recruiting
- BayCare Medical Group Primary Care and Rheumatology - Tampa
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Massachusetts
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Boston, Massachusetts, United States, 02111-1527
- Recruiting
- Tufts University School of Dental Medicine
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Michigan
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Saint Clair Shores, Michigan, United States, 48081-1274
- Recruiting
- Shores Rheumatology
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Missouri
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Kansas City, Missouri, United States, 64151
- Recruiting
- Kansas City Physician Partners-8350 N Saint Clair Ave
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New Jersey
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Voorhees Township, New Jersey, United States, 08043-4501
- Recruiting
- Arthritis, Rheumatic & Bone Disease Associates - Voorhees
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North Carolina
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Charlotte, North Carolina, United States, 28207-1100
- Recruiting
- Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd
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Durham, North Carolina, United States, 27710-0001
- Recruiting
- Duke Early Phase Clinical Research Unit - PPDS
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Salisbury, North Carolina, United States, 28144
- Recruiting
- Onsite Clinical Solutions, LLC - Salisbury
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Ohio
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Miamisburg, Ohio, United States, 45342-3585
- Recruiting
- Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg
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Toledo, Ohio, United States, 43614-2595
- Recruiting
- University of Toledo Medical Center
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Vandalia, Ohio, United States, 45377-9474
- Recruiting
- STAT Research-600 Aviator Ct
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Tennessee
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Murfreesboro, Tennessee, United States, 37128
- Recruiting
- Murfreesboro Medical Clinic Westlawn
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Texas
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Baytown, Texas, United States, 77521-2279
- Recruiting
- Accurate Clinical Management-Baytown
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Colleyville, Texas, United States, 76034-5913
- Recruiting
- Precision Comprehensive Clinical Research Solutions
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Katy, Texas, United States, 77450-2297
- Recruiting
- R & H Clinical Research-777 S Fry Rd
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Katy, Texas, United States, 77494-1341
- Recruiting
- Houston Rheumatology & Arthritis Specialists - PLLC - PPDS
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McAllen, Texas, United States, 78503-1527
- Recruiting
- Biopharma Informatic - Ridge Road - PPDS
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The Woodlands, Texas, United States, 77382-2935
- Recruiting
- Advanced Rheumatology of Houston
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Tomball, Texas, United States, 77375
- Recruiting
- DM Clinical Research - Migraine and COPD - PPDS
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Washington
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Bothell, Washington, United States, 98021
- Recruiting
- Western Washington Medical Group, Bothell - Rheumatology
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West Virginia
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Beckley, West Virginia, United States, 25801-2805
- Recruiting
- Rheumatology and Pulmonary Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Participants are eligible to be included in the study only if all the following criteria apply:
- Participant has provided informed consent before initiation of any study specific activities/procedures.
- Must have been eligible to receive and have received IP (dazodalibep or placebo) and completed the study (through Week 48) in one of the phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303).
- Must be able to receive Dose 1 of this LTE study at the Week 48 Visit (+28 days) for the prior pivotal phase 3 SS dazodalibep studies (HZNP DAZ-301, or HZNP DAZ-303).
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- Clinically significant active infection at Day 1, in the opinion of the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication.
- Planned participation in another clinical study with an IP or procedure during the LTE study. Other investigational procedures and participation in observational research studies while participating in this study are excluded.
- Any condition or change in health status observed or reported during the phase 3 SS studies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety or alter the risk-benefit associated with IP administration.
- Planned surgeries or hospitalizations that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety.
- Individuals who plan to receive live (attenuated) vaccine during the LTE study.
- Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 12 weeks after the last dose of investigational product.
- Female participants who are pregnant or lactating or planning to become pregnant during the study.
- Participant has known sensitivity to any of the products or components to be administered during dosing.
- Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
1
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Dazodalibep
Participants who completed the 48-week dazodalibep or placebo treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive assigned dose Dose A of dazodalibep for an additional 132 weeks.
|
Dazodalibep will be given intravenously (IV).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 152 weeks
|
Includes treatment emergent serious adverse events (TESAEs) and adverse events of special interest (AESIs).
|
Up to 152 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Participants with Anti-drug Antibodies (ADAs) During the Study
Time Frame: Up to 132 weeks
|
Up to 132 weeks
|
|
Plasma Concentration of Dazodalibep
Time Frame: Up to 132 weeks
|
Up to 132 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Sponsor
Investigators
Investigators
- Study Director: MD, Amgen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
Study Start
February 25, 2025
Primary Completion (Estimated)
Primary Completion
December 11, 2029
Study Completion (Estimated)
Study Completion
December 11, 2029
Study Registration Dates
First Submitted
First Submitted
December 19, 2024
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
December 19, 2024
First Posted (Actual)
First Posted
December 24, 2024
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
April 28, 2026
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
Last Verified
April 1, 2026
More Information
Terms related to this study
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
Other Study ID Numbers
Other Study ID Numbers
- HZNP-DAZ-304
- 20230050 (Other Identifier: Amgen)
- 2024-517513-32-00 (Other Identifier: EU CT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities.
There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s).
In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling.
Requests are reviewed by a committee of internal advisors.
If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision.
Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.
This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code were provided in analysis specifications.
Further details are available at the URL below.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.