A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults with Active Idiopathic Inflammatory Myopathy
- Conditions
- MyositisPolymyositisDermatomyositisImmune-Mediated Necrotizing MyopathyAntisynthetase SyndromeActive Idiopathic Inflammatory Myopathy
- Interventions
- Registration Number
- NCT05979441
- Lead Sponsor
- argenx
- Brief Summary
The purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with IIM who previously participated in ARGX-113-2007. Secondary objectives include efficacy measures of efgartigimod PH20 SC in participants with IIM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 240
- Has completed trial ARGX-113-2007
- Being capable of providing signed informed consent and complying with protocol requirements
- Agrees to use contraceptive measures consistent with local regulations and women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the investigational medicinal product
- Intention to have major surgery during the study period; or any other medical condition that has arisen since enrollment in study ARGX-113-2007, that in the investigator's opinion, would confound the results of the study or put the participant at undue risk
- Known hypersensitivity reaction to investigational medicinal product or 1 of its excipients Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness
- Permanent discontinuation of IMP in ARGX-113-2007, or met the permanent discontinuation criteria at the rollover visit
- Diagnosis with a deselected subtype of myositis based on the analysis of the phase 2 stage data in ARGX-113-2007, unless the investigator determines that the participant is benefiting from IMP as defined by a score of "much better" or "moderately better" on the 'Clinical Global Impression of Change' and 'Patient Global
- Impression of Change' assessments for at least 12 weeks, and that enrolling in the study is in the participant's best interest
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EFG PH20 SC EFG PH20 SC participants receiving efgartigimod PH20 SC on top of background treatment
- Primary Outcome Measures
Name Time Method Incidence treatment-emergent adverse events and adverse event of special interest Up to 60 weeks
- Secondary Outcome Measures
Name Time Method Total improvement score (TIS) Up to 52 weeks measured on a \[0,100\] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS) Up to 52 weeks Prednisone dose reduction (average monthly dose) Up to 52 weeks Percentage of participants with clinically inactive disease up to 52 weeks Proportion of TIS responders (minimal, moderate, major) up to 52 weeks Percentage of participants with remission, defined as a clinically inactive disease for at least 24 weeks up to 52 weeks Proportion of participants who discontinue corticosteroids Up to 52 weeks Individual core set measures (CSMs) of the TIS up to 52 weeks measured on a \[0,100\] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
Trial Locations
- Locations (44)
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
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
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
Centro Medico Privado de Reumatologia
🇦🇷San Miguel De Tucumán, Argentina
Centro Dermatologico Schejtman
🇦🇷San Miguel, Argentina
Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck - Neurology
🇦🇹Innsbruck, Austria
AZ Sint-Lucas - Campus Sint-Lucas - Neurology
🇧🇪Gent, Belgium
Universitair Ziekenhuis Leuven Gasthuisberg Campus
🇧🇪Leuven, Belgium
Medical Centre Artmed
🇧🇬Plovdiv, Bulgaria
Cyprus Institute of Neurology and Genetics
🇨🇾Nicosia, Cyprus
Revmatologicky Ustav
🇨🇿Praha, 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 Tuebingen (UKT)
🇩🇪Tuebingen, Germany
National and Kapodistrian University of Athens - Eginition Hospital
🇬🇷Athens, Greece
ATTIKON University General Hospital - Neurology
🇬🇷Athens, Greece
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
Fondazione Policlinico Universitario Agostino Gemelli - Neurology
🇮🇹Roma, Italy
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Santaros University Clinic
🇱🇹Vilnius, Lithuania
Clinica San Juan de Dios - sede Arequipa - Rheumatology
🇵🇪Arequipa, Peru
Centrum Wsparcia Badan Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie (CWBK PUM) - Rheumatology
🇵🇱Szczecin, Poland
USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113 - Rheumatology
🇵🇱Łódź, Poland
Hospital Universitari i Politecnic La Fe de Valencia - Neurology
🇪🇸Valencia, Spain
Karolinska Universitestssjukhus Solna
🇸🇪Solna, Sweden
Chung Shan Medical University Hospital
🇨🇳Taichung City, Taiwan
King Chulalongkorn Memorial Hospital - Neurology
🇹🇭Bangkok, Thailand
Phramongkutklao Hospital
🇹🇭Bangkok, Thailand
Faculty Of Medicine, Khon Kaen University
🇹🇭Khon Kaen, Thailand
Northern Care Allicance NHS Foundation Trust - Salford Royal - Rheumatology
🇬🇧Salford, United Kingdom