Phase
Condition
Dermatomyositis (Connective Tissue Disease)
Sjogren's Syndrome
Treatment
Dazodalibep
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 specificactivities/procedures.
Must have been eligible to receive and have received IP (dazodalibep or placebo) andcompleted 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) forthe prior pivotal phase 3 SS dazodalibep studies (HZNP DAZ-301, or HZNP DAZ-303).
Exclusion
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 theInvestigator, including ongoing and chronic infection requiring antibiotics orantiviral medication.
Planned participation in another clinical study with an IP or procedure during theLTE study. Other investigational procedures and participation in observationalresearch studies while participating in this study are excluded.
Any condition or change in health status observed or reported during the phase 3 SSstudies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the Investigator orthe Sponsor, would interfere with evaluation and interpretation of participantsafety or alter the risk-benefit associated with IP administration.
Planned surgeries or hospitalizations that, in the opinion of the Investigator orthe Sponsor, would interfere with evaluation and interpretation of participantsafety.
Individuals who plan to receive live (attenuated) vaccine during the LTE study.
Female participants of childbearing potential unwilling to use protocol-specifiedmethod of contraception during treatment and for an additional 12 weeks after thelast dose of investigational product.
Female participants who are pregnant or lactating or planning to become pregnantduring the study.
Participant has known sensitivity to any of the products or components to beadministered during dosing.
Participant likely to not be available to complete all protocol-required studyvisits or procedures, and/or to comply with all required study procedures to thebest of the participant and investigator's knowledge.
History or evidence of any other clinically significant disorder, condition, ordisease 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 Design
Connect with a study center
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ABP
ArgentinaActive - Recruiting
Instituto CER S.A.
Quilmes, Buenos Aires B1878DVB
ArgentinaActive - Recruiting
Instituto de Investigaciones Clinicas Quilmes SRL
Quilmes, Buenos Aires B1878GEG
ArgentinaActive - Recruiting
MR Medicina Reumatologica
San Fernando, Buenos Aires B1646GHP
ArgentinaActive - Recruiting
DOM Centro de Reumatología
Buenos Aires, Ciudad Autónoma de BuenosAires C1111
ArgentinaActive - Recruiting
Centro Medico Privado de Reumatologia - PPDS
San Miguel de Tucumán, Tucumán Province T4000AXL
ArgentinaActive - Recruiting
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, Tucumán Province T4000AXL
ArgentinaActive - Recruiting
Clínica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Tucumán Province T4000IHE
ArgentinaActive - Recruiting
Aprillus Asistencia e Investigacion - Terrada 89
Buenos Aires, 1406
ArgentinaActive - Recruiting
Centro Medico Arsema
Buenos Aires, C1427CCL
ArgentinaActive - Recruiting
Hospital General de Agudos Dr. José María Ramos Mejia
Buenos Aires, C1121ADC
ArgentinaActive - Recruiting
Sanatorio Agote - Swiss Medical Group - PPDS
Buenos Aires, C1425EOE
ArgentinaActive - Recruiting
Sanatorio Allende S.A.-Hipolito Yrigoyen 384
Córdoba, X5000JHQ
ArgentinaActive - Recruiting
Framingham Centro Médico
La Plata, B1902COS
ArgentinaActive - Recruiting
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
San Juan, J5402DIL
ArgentinaActive - Recruiting
The Queen Elizabeth Hospital
Woodville South, South Australia 5011
AustraliaActive - Recruiting
UZ Gent
Ghent, 9000
BelgiumActive - Recruiting
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
Salvador, Estado de Bahia 40150-150
BrazilActive - Recruiting
Centro de Estudos em Terapias Inovadoras
Curitiba, Paraná 80030-110
BrazilActive - Recruiting
LMK Servicos Medicos SS
Porto Alegre, Rio Grande do Sul 90480-000
BrazilActive - Recruiting
Clinique de Rhumatologie Du Centre Du Quebec
Trois-Rivières, Quebec G8Z 1Y2
CanadaActive - Recruiting
Centro de Investigacion de Enfermedades Respiratorias e inmunologicas
Viña del Mar, Valparaiso 2520000
ChileActive - Recruiting
Enroll SpA - Dr. Manuel Barros Borgono - PPDS
Providencia, 7500000
ChileActive - Recruiting
BIOCINETIC Ltda
Santiago, 8350595
ChileActive - Recruiting
Centro de especialidades médicas Vanguardia
Temuco, 4810345
ChileActive - Recruiting
Clinical Research Chile SpA - PPDS
Valdivia, 5110683
ChileActive - Recruiting
Polyclinic Bonifarm
Zagreb, City of Zagreb 10000
CroatiaActive - Recruiting
University Hospital of Split
Split, 21000
CroatiaActive - Recruiting
CHU de Bordeaux - Hôpital Saint-André
Bordeaux, 33000
FranceActive - Recruiting
CHU de Brest - Hôpital La Cavale Blanche
Brest, 29200
FranceActive - Recruiting
GHRMSA - Hôpital Emile Muller
Mulhouse, 68100
FranceActive - Recruiting
AP-HP - Hôpital Saint Antoine
Paris, 75012
FranceActive - Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
FranceActive - Recruiting
University Clinic Heidelberg
Heidelberg, Baden-Wurttemberg 69120
GermanyActive - Recruiting
Rheumazentrum Prof. Dr. med. Gunther Neeck-Standort Bad Doberan
Bad Doberan, Mecklenburg-Vorpommern 18209
GermanyActive - Recruiting
Rheumazentrum Greifswald
Greifswald Hansestadt, Mecklenburg-Vorpommern 17493
GermanyActive - Recruiting
MVZ Rheuma
Hamburg, 20095
GermanyActive - Recruiting
Laiko General Hospital of Athens
Athens, Attica 115 27
GreeceActive - Recruiting
Naval Hospital of Athens
Athens, Attica 115 21
GreeceActive - Recruiting
University General Hospital of Larissa
Larissa, Larisa 411 10
GreeceActive - Recruiting
Euromedica Kianous Stavros
Thessaloniki, 546 36
GreeceActive - Recruiting
Bekes Varmegyei Kozponti Korhaz
Gyula, Bekes County 5700
HungaryActive - Recruiting
Vasarhelyi Sarkanyfu Kft.
Hódmezovásárhely, Csongrád megye 6800
HungaryActive - Recruiting
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
Debrecen, Hajdú-Bihar 4032
HungaryActive - Recruiting
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7
Budapest, 1097
HungaryActive - Recruiting
Meir Medical Center
Kafr Saba, Central District 4428164
IsraelActive - Recruiting
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Tel Aviv 5262100
IsraelActive - Recruiting
Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia
Udine, Friuli Venezia Giulia 33100
ItalyActive - Recruiting
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome, Lazio 00168
ItalyActive - Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Lazio 128
ItalyActive - Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy 20122
ItalyActive - Recruiting
A.O.U. Città della Salute e della Scienza di Torino
Turin, Piedmont 10126
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, Veneto 37126
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa, 56126
ItalyActive - Recruiting
AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
ItalyActive - Recruiting
Daido Clinic
Nagoya, Akita 457-8511
JapanActive - Recruiting
Chubu Rosai Hospital
Nagoya-shi, Akita 455-0018
JapanActive - Recruiting
Japan Community Health Care Organization (JCHO) Chukyo Hospital
Nagoya-shi, Akita 457-0866
JapanActive - Recruiting
Hokkaido University Hospital
Sapporo, Hokkaidô 060-8648
JapanActive - Recruiting
Sapporo Medical University Hospital
Sapporo, Hokkaidô 060-8543
JapanActive - Recruiting
Hospital of the University of Occupational and Environmental Health, Japan
Kita Kyushu-shi, Hukuoka 807-8556
JapanActive - Recruiting
University of Tsukuba Hospital
Tsukuba, Ibaraki 305-8576
JapanActive - Recruiting
Kanazawa Medical University Hospital
Kahoku, Ishikawa-ken 920-0293
JapanActive - Recruiting
Kanazawa University Hospital
Kanazawa, Ishikawa-ken 920-8641
JapanActive - Recruiting
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa 245-8575
JapanActive - Recruiting
Kyoto University Hospital
Kyoto, Kyôto 606-8507
JapanActive - Recruiting
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Kyôto 602-8566
JapanActive - Recruiting
Nagasaki University Hospital
Nagasaki, Nagasaki 852-8501
JapanActive - Recruiting
Sasebo Chuo Hospital
Sasebo-Shi, Nagasaki 857-1165
JapanActive - Recruiting
Kurashiki Medical Clinic
Kurashiki-Shi, Okayama-ken 710-0824
JapanActive - Recruiting
Saitama Medical University Hospital
Iruma-Gun Moroyama-Machi, Saitama 350-0451
JapanActive - Recruiting
Hamamatsu University Hospital
Hamamatsu, Shizuoka 431-3192
JapanActive - Recruiting
St. Luke's International Hospital
Chuo-Ku, Tokyo 104-0044
JapanActive - Recruiting
Nihon University Itabashi Hospital
Itabashi-Ku, Tokyo 173-0032
JapanActive - Recruiting
Tokyo Medical Center
Meguro-Ku, Tokyo 152-0021
JapanActive - Recruiting
Keio University Hospital
Shinjuku-Ku, Tokyo 160-8582
JapanActive - Recruiting
Mediadvance Clinical S.A.P.I. de C.V.
Parques de San Felipe, Chihuahua 31203
MexicoActive - Recruiting
Centro de Investigación en Artritis y Osteoporosis - PPDS
Mexicali, Estado de Baja California 21200
MexicoActive - Recruiting
Centro de Estudios de Investigacion Basica Y Clinica SC
Guadalajara, Jalisco 44690
MexicoActive - Recruiting
Centro de Investigación y Tratamiento Reumatológico S.C
Mexico City, Mexico City 11850
MexicoActive - Recruiting
Cryptex Investigación Clínica, S.A. de C.V.
Mexico City, Mexico City 6100
MexicoActive - Recruiting
Clinstile, S.A. de C.V.
Mexico City, 6700
MexicoActive - Recruiting
Unidad de Atención Medica e Investigación en Salud
Mérida, 97000
MexicoActive - Recruiting
Consultorio de Reumatologia
México, 7760
MexicoActive - Recruiting
Optimal Clinical Trials Ltd - PPDS
Auckland, North Island 1003
New ZealandActive - Recruiting
Health New Zealand - Te Whatu Ora - Waikato (Waikato Hospital)
Hamilton, 3240
New ZealandActive - Recruiting
Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS
Papatoetoe, 2025
New ZealandActive - Recruiting
Clinica San Antonio S.A.C
Trujillo, La Libertad 13008
PeruActive - Recruiting
Medicentro Biociencias Peru S.R.L.
Pueblo Libre, Lima region 1508
PeruActive - Recruiting
Hospital Militar Central Luis Arias Schereiber
Jesus Maria, 15001
PeruActive - Recruiting
Instituto de Ginecologia y Reproduccion - PPDS
Santiago de Surco, 33
PeruActive - Recruiting
Med-Polonia Sp. z o.o.
Poznan, Greater Poland Voivodeship 60-693
PolandActive - Recruiting
Pratia Poznan - PPDS
Poznan, Greater Poland Voivodeship 60-192
PolandActive - Recruiting
Malopolskie Centrum Kliniczne
Krakow, Lesser Poland Voivodeship 30-149
PolandActive - Recruiting
Centrum Medyczne Oporow
Wroclaw, Lower Silesian Voivodeship 52-416
PolandActive - Recruiting
ETG Lublin - PPDS
Lublin, Lublin Voivodeship 20-412
PolandActive - Recruiting
Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4
Lublin, Lublin Voivodeship 20-607
PolandActive - Recruiting
Centrum Medyczne Reuma Park
Warsaw, Masovian Voivodeship 02-665
PolandActive - Recruiting
MICS Centrum Medyczne Warszawa, Wronia - MICS
Warsaw, Masovian Voivodeship 00-874
PolandActive - Recruiting
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, Masovian Voivodeship 02-172
PolandActive - Recruiting
WIM-PIB, Centralny Szpital Kliniczny MON
Warsaw, Masovian Voivodeship 04-141
PolandActive - Recruiting
Centrum Medyczne K2J2 - Wołomin
Wołomin, Masovian Voivodeship 05-200
PolandActive - Recruiting
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.
Malbork, Pomeranian Voivodeship 82-200
PolandActive - Recruiting
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85-065
PolandActive - Recruiting
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
PolandActive - Recruiting
Centrum Medyczne Pratia Katowice - PPDS
Katowice, 40-081
PolandActive - Recruiting
Centrum Medyczne PROMED- Olszanska 5G
Krakow, 31-513
PolandActive - Recruiting
Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
Krakow, 30-363
PolandActive - Recruiting
FutureMeds - Lodz - PPDS
Lodz, 91-363
PolandActive - Recruiting
Prywatna Praktyka Lekarska Pawel Hrycaj
Poznan, 61-397
PolandActive - Recruiting
Twoja Przychodnia PCM
Poznan, 60-324
PolandActive - Recruiting
ETG Warszawa - PPDS
Warsaw, 02-677
PolandActive - Recruiting
FutureMeds - Targowek - PPDS
Warsaw, 03-291
PolandActive - Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
Warsaw, 02-637
PolandActive - Recruiting
FutureMeds - Wroclaw - PPDS
Wroclaw, 53-673
PolandActive - Recruiting
Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3
Wroclaw, 53-034
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213
Wroclaw, 50-556
PolandActive - Recruiting
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon, Lisbon District 1349-019
PortugalActive - Recruiting
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
Lisbon, Lisbon District 1649-035
PortugalActive - Recruiting
Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
Ponte de Lima, 4990-150
PortugalActive - Recruiting
ULS de Gaia/Espinho, EPE - Unidade I
Vila Nova de Gaia, 4434-502
PortugalActive - Recruiting
Military Medical Academy
Belgrade, Belgrade 11000
SerbiaActive - Recruiting
Institute of Rheumatology - PPDS
Belgrade, 11000
SerbiaActive - Recruiting
Klinika za Alergologiju i Imunologiju
Belgrade, 112108
SerbiaActive - Recruiting
University Clinical Center Kragujevac
Kragujevac, 34000
SerbiaActive - Recruiting
Clinical Centre of Vojvodina
Novi Sad, 21000
SerbiaActive - Recruiting
Special Hospital For Rheumatic Diseases Novi Sad
Novi Sad, 21000
SerbiaActive - Recruiting
University Clinical Centre Maribor
Maribor, 2000
SloveniaActive - Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul Teugbyeolsi 6591
South KoreaActive - Recruiting
Fundacio Hospital de l'Esperit Sant
Santa Coloma de Gramenet, Barcelona 08923
SpainActive - Recruiting
C.H. Regional Reina Sofia - PPDS
Córdoba, Córdoba 14004
SpainActive - Recruiting
Hospital Universitario de Basurto
Bilbao, Vizcaya 48013
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario Infanta Leonor
Madrid, 28031
SpainActive - Recruiting
Hospital Quironsalud Infanta Luisa
Seville, 41010
SpainActive - Recruiting
Hospital Universitario de Valme
Seville, 41014
SpainActive - Recruiting
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, 80756
TaiwanActive - Recruiting
Taichung Veterans General Hospital
Taichung, 40705
TaiwanActive - Recruiting
Taipei Medical University Hospital - PPDS
Taipei, 11031
TaiwanActive - Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan District, 33305
TaiwanActive - Recruiting
Queen Alexandra Hospital
Portsmouth, Hampshire PO6 3LY
United KingdomActive - Recruiting
Chapel Allerton Hospital - PPDS
Leeds, LS7 4SA
United KingdomActive - Recruiting
Mile End Hospital - PPDS
London, E1 4DG
United KingdomActive - Recruiting
Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona 85392
United StatesActive - Recruiting
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
Flagstaff, Arizona 86001-6269
United StatesActive - Recruiting
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
Gilbert, Arizona 85297-7336
United StatesActive - Recruiting
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
Glendale, Arizona 85306-9800
United StatesActive - Recruiting
Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
Tucson, Arizona 85704-1139
United StatesActive - Recruiting
Samy Metyas MD Inc
Covina, California 91723
United StatesActive - Recruiting
UCSD Altman Clinical and Translational Research Institute Building
La Jolla, California 92037-1337
United StatesActive - Recruiting
Tekton Research, LLC - 2121 E Harmony Rd - PPDS
Fort Collins, Colorado 80528-3400
United StatesActive - Recruiting
Bradenton Research Center Inc
Bradenton, Florida 34205-1704
United StatesActive - Recruiting
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida 33765-2616
United StatesActive - Recruiting
BayCare Medical Group Primary Care and Rheumatology - Tampa
Tampa, Florida 33614-7101
United StatesActive - Recruiting
Tufts University School of Dental Medicine
Boston, Massachusetts 02111-1527
United StatesActive - Recruiting
Shores Rheumatology
Saint Clair Shores, Michigan 48081-1274
United StatesActive - Recruiting
Kansas City Physician Partners-8350 N Saint Clair Ave
Kansas City, Missouri 64151
United StatesActive - Recruiting
Arthritis, Rheumatic & Bone Disease Associates - Voorhees
Voorhees Township, New Jersey 08043-4501
United StatesActive - Recruiting
Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd
Charlotte, North Carolina 28207-1100
United StatesActive - Recruiting
Duke Early Phase Clinical Research Unit - PPDS
Durham, North Carolina 27710-0001
United StatesActive - Recruiting
Onsite Clinical Solutions, LLC - Salisbury
Salisbury, North Carolina 28144
United StatesActive - Recruiting
Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg
Miamisburg, Ohio 45342-3585
United StatesActive - Recruiting
University of Toledo Medical Center
Toledo, Ohio 43614-2595
United StatesActive - Recruiting
STAT Research-600 Aviator Ct
Vandalia, Ohio 45377-9474
United StatesActive - Recruiting
Murfreesboro Medical Clinic Westlawn
Murfreesboro, Tennessee 37128
United StatesActive - Recruiting
Accurate Clinical Management-Baytown
Baytown, Texas 77521-2279
United StatesActive - Recruiting
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas 76034-5913
United StatesActive - Recruiting
Houston Rheumatology & Arthritis Specialists - PLLC - PPDS
Katy, Texas 77494-1341
United StatesActive - Recruiting
R & H Clinical Research-777 S Fry Rd
Katy, Texas 77450-2297
United StatesActive - Recruiting
Biopharma Informatic - Ridge Road - PPDS
McAllen, Texas 78503-1527
United StatesActive - Recruiting
Advanced Rheumatology of Houston
The Woodlands, Texas 77382-2935
United StatesActive - Recruiting
DM Clinical Research - Migraine and COPD - PPDS
Tomball, Texas 77375
United StatesActive - Recruiting
Western Washington Medical Group, Bothell - Rheumatology
Bothell, Washington 98021
United StatesActive - Recruiting
Rheumatology and Pulmonary Clinic
Beckley, West Virginia 25801-2805
United StatesActive - Recruiting

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