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A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
Sponsor: argenx
Summary
The main purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in ARGX-113-2007. The study consists of a treatment period where participants will receive efgartigimod PH20 SC for up to 51 months. The treatment period will be followed by a treatment-free safety follow-up period of 56 days.
Official title: A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2023-09-12
Completion Date
2028-09
Last Updated
2026-03-10
Healthy Volunteers
No
Conditions
Interventions
Efgartigimod PH20 SC
Subcutaneous injection of Efgartigimod PH20 given by vials or prefilled syringe (PFS)
Locations (80)
Neuromuscular Clinical and Research Center - Neurology
Phoenix, Arizona, United States
Attune Health Research, Inc
Beverly Hills, California, United States
UCI Health - ALS and Neuromuscular Center - Neurology
Orange, California, United States
UCSF Health - ALS and Neurodegenerative Disease Center - Dermatology
San Francisco, California, United States
Yale Cancer Center-Yale University School Of Medicine
New Haven, Connecticut, United States
UF Health - Rheumatology Medical Specialties Medical Plaza
Gainesville, Florida, United States
Mayo Clinic - Florida - Neurology
Jacksonville, Florida, United States
Emory Healthcare - Emory Clinic - Rheumatology
Atlanta, Georgia, United States
Northwestern Medicine - Northwestern Memorial Hospital
Chicago, Illinois, United States
Northwell Health Physician Partners Rheumatology
Great Neck, New York, United States
University of North Carolina (UNC) School of Medicine
Chapel Hill, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Austin Neuromuscular Center (National Neuromuscular Research Institute, PLLC)
Austin, Texas, United States
Nerve And Muscle Center Of Texas
Houston, Texas, United States
Framingham Centro Medico
La Plata, Argentina
Centro Dermatologico Schejtman
San Miguel, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Argentina
Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck - Neurology
Innsbruck, Austria
AZ Sint-Lucas - Campus Sint-Lucas - Neurology
Ghent, Belgium
Universitair Ziekenhuis Leuven Gasthuisberg Campus
Leuven, Belgium
Medical Centre Artmed
Plovdiv, Bulgaria
Multiprofile hospital for active treatment Kaspela EOOD
Plovdiv, Bulgaria
Peking Union Medical College Hospital
Beijing, China
Sichuan Provincial Academy of Medical Sciences and Sichuan Provincial People's Hospital
Chengdu, China
Shanghai Jiao Tong University School of Medicine - Renji Hospital - Shanghai Institute of Digestive Disease (SIDD)
Shanghai, China
Cyprus Institute of Neurology and Genetics
Nicosia, Cyprus
Revmatologicky Ustav
Prague, Czechia
Copenhagen University Hospital-Rigshospitalet University Hospital
Copenhagen, Denmark
Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix
Paris, France
Aversi Clinic
Tbilisi, Georgia
LLC MediClub Georgia
Tbilisi, Georgia
New Hospitals
Tbilisi, Georgia
The First Medical Center
Tbilisi, Georgia
Charite Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Rheumatology
Berlin, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany
Rheumazentrum Ruhrgebiet
Herne, Germany
Universitatsmedizin Mannheim GmbH
Mannheim, Germany
Universitaetsklinikum Tuebingen (UKT)
Tübingen, Germany
Klinikum der Universitaet Ulm
Ulm, Germany
National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine
Athens, Greece
National and Kapodistrian University of Athens - Eginition Hospital
Athens, Greece
ATTIKON University General Hospital - Neurology
Athens, Greece
University College Dublin (UCD) - St. Vincent's University Hospital (SVUH)
Dublin, Ireland
Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
Milan, Italy
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara - Rheumatology
Pisa, Italy
Ospedale Sant'Andrea Hospital
Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli - Neurology
Roma, Italy
Azienda sanitaria universitaria Friuli Centrale - ASUFC
Udine, Italy
Juntendo University Hospital
Bunkyō City, Japan
The University of Tokyo Hospital
Bunkyō City, Japan
Japan Community Healthcare Organization Chukyo Hospital
Nagoya, Japan
Wakayama Medical University Hospital
Wakayama, Japan
Santaros University Clinic
Vilnius, Lithuania
Hospital Angeles Clinica Londres
Mexico City, Mexico
Amsterdam UMC Research BV
Amsterdam, Netherlands
Clinica San Juan de Dios - sede Arequipa - Rheumatology
Arequipa, Peru
Instituto Peruano Del Hueso Y La Articulacion Sac-Privado-Lima,Centro De Investigacion Iphar
Lima, Peru
Investigaciones Clinicas S.A.C.
Lima, Peru
USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113 - Rheumatology
Lodz, Poland
Centrum Wsparcia Badan Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie (CWBK PUM) - Rheumatology
Szczecin, Poland
Centro Hospitalar do Porto - Hospital Santo Antonio
Porto, Portugal
Clinical Center of Serbia
Belgrade, Serbia
Institute of Rheumatology
Belgrade, Serbia
Seoul National University Hospital
Seoul, South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitari i Politecnic La Fe de Valencia - Neurology
Valencia, Spain
Karolinska Universitestssjukhus Solna
Solna, Sweden
Chung Shan Medical University Hospital
Taichung, Taiwan
King Chulalongkorn Memorial Hospital - Neurology
Bangkok, Thailand
Phramongkutklao Hospital
Bangkok, Thailand
Ramathibodi hospital
Bangkok, Thailand
Siriraj Hospital, Mahidol University of Internal medicine
Bangkok, Thailand
Faculty Of Medicine, Khon Kaen University
Khon Kaen, Thailand
Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom
The Royal Free Hospital
London, United Kingdom
Northern Care Allicance NHS Foundation Trust - Salford Royal - Rheumatology
Salford, United Kingdom