A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
NCT ID: NCT05523167
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
265 participants
INTERVENTIONAL
2022-10-12
2027-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EFG PH20 SC
participants receiving efgartigimod PH20 SC on top of background treatment
EFG PH20 SC
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
PBO PH20 SC
participants receiving placebo PH20 SC on top of background treatment
PBO
Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer
Interventions
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EFG PH20 SC
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
PBO
Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer
Eligibility Criteria
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Inclusion Criteria
* A definite or probable clinical diagnosis of idiopathic inflammatory myopathy (IIM)
* One of the following medical histories: Diagnosis of dermatomyositis (DM) or juvenile dermatomyositis (JDM), Diagnosis of polymyositis (PM) (including antisynthetase syndrome (ASyS)), Diagnosis of immune-mediated necrotizing myopathy (IMNM)
* Diagnosed with active disease as defined by the presence of at least 1 of the following criteria: Abnormal levels of at least 1 of the following enzymes: creatine kinase (CK), aldolase, lactate dehydrogenase, aspartate aminotransaminase (AST), alanine aminotransferase (ALT), based on central laboratory results; Electromyography demonstrating active disease within the past 3 months; Active dermatomyositis (DM) skin rash; Muscle biopsy indicative of active idiopathic inflammatory myopathy (IIM) in the past 3 months; Magnetic resonance imaging within the past 3 months indicative of active inflammation
* Muscle weakness
* Receiving a permitted background treatment for idiopathic inflammatory myopathy.
* Contraceptive use consistent with local regulations, where available, for individuals participating in clinical studies. Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline before receiving investigational medicinal product (IMP).
Exclusion Criteria
* A COVID-19 polymerase chain reaction (PCR)-positive test before enrollment
* Any other known autoimmune disease that, in the investigator's opinion, would interfere with an accurate assessment of clinical symptoms of idiopathic inflammatory myopathy (IIM) or put the patient at undue risk
* A history of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for ≥ 3 years before the first administration of the investigational medicinal product (IMP). Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer ; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer
* Severe muscle damage
* Glucocorticoid-induced myopathy that the investigator considers the primary cause of muscle weakness or permanent weakness linked to a non-idiopathic inflammatory myopathy (IIM) cause
* Juvenile myositis (JDM) diagnosed \> 5 years from screening or juvenile myositis with extensive calcinosis or severe calcinosis.
* Uncontrolled interstitial lung disease or any other uncontrolled idiopathic inflammatory myopathy (IIM) manifestation that, in the opinion of the investigator, would be likely to require treatment with prohibited medication during the study
* Other inflammatory and noninflammatory myopathies: inclusion body myositis, overlap myositis), metabolic myopathies, muscle dystrophies or a family history of muscle dystrophy, drug-induced or endocrine induced myositis, and juvenile myositis (other than juvenile dermatomyositis (JDM))
* Clinically significant disease, recent major surgery or intends to have surgery during the study, or has any other condition in the opinion of the investigator that could confound the results of the trial or put the patient at undue risk
* Known hypersensitivity reaction to investigational medicinal product (IMP) or 1 of its excipients
* Received a live or live-attenuated vaccine less than 4 weeks before screening.
* Positive serum test at screening for active viral infection with any of the following conditions: Hepatitis B virus (HBV); Hepatitis C virus (HCV); HIV
* Participant has previously participated in an efgartigimod clinical trial and received at least 1 dose of investigational medicinal product (IMP).
* Participant is concurrently participating in any other clinical study, including a noninterventional study.
* Participant has a current or history (ie, within 12 months of screening) of alcohol, drug, or medication abuse.
* Participant is pregnant or lactating or intends to become pregnant during the study.
* Participant has severe renal impairment .
* Participant is institutionalized by a court or other governmental order or is in a dependent relationship with the sponsor or investigator.
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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Neuromuscular Research Center
Phoenix, Arizona, United States
HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
Scottsdale, Arizona, United States
Attune Health Research, Inc
Beverly Hills, California, United States
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, United States
Profound Research LLC - Oceanside
Oceanside, California, United States
University of California, Irvine
Orange, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine
Redwood City, California, United States
California Pacific Medical Center - Sutter Health
San Francisco, California, United States
Amyotrophic Lateral Sclerosis (ALS) Treatment Center,University of California San Francisco (UCSF)
San Francisco, California, United States
Denver Arthritis Clinic
Denver, Colorado, United States
Yale Cancer Center-Yale University School Of Medicine
New Haven, Connecticut, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
UF Health Rheumatology
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
Tampa, Florida, United States
Emory University Hospital, The Emory Clinic
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University Of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins Medicine - Johns Hopkins Myositis Center
Baltimore, Maryland, United States
Harvard Medical School - Brigham and Women's Hospital (BWH) - The Schuster Family Transplantation Research Center (TRC)
Boston, Massachusetts, United States
Michigan State University - Neurology
East Lansing, Michigan, United States
St. Paul Rheumatology, PA
Saint Paul, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Northwell Health
Great Neck, New York, United States
Hospital for Special Surgery
New York, New York, United States
University of North Carolina (UNC) School of Medicine
Chapel Hill, North Carolina, United States
Carolina Arthritis Associates
Wilmington, North Carolina, United States
Cleveland Clinic - Main Campus
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic
Nashville, Tennessee, United States
Austin Neuromuscular Center
Austin, Texas, United States
McGovern Medical School -The University of Texas Health Science Center at Houston
Houston, Texas, United States
Nerve And Muscle Center Of Texas
Houston, Texas, United States
University of Vermont Medical Center - Main Campus
Burlington, Vermont, United States
University of Washington Medical Center
Seattle, Washington, United States
Consultora Integral de Salud
Córdoba, , Argentina
Framingham Centro Medico
La Plata, , Argentina
Dim Clinica Privada
Ramos Mejía, , Argentina
Centro Dermatologico Schejtman
San Miguel, , Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, , Argentina
The Wesley Medical Research
Auchenflower, , Australia
Fiona Stanley Hospital
Murdoch, , Australia
Medical University Innsbruck
Innsbruck, , Austria
Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
Vienna, , Austria
Centre Hospitalier Universitaire de Charleroi
Charleroi, , Belgium
AZ Sint Lucas Gent-Campus Sint Lucas
Ghent, , Belgium
Universitair Ziekenhuis Leuven Gasthuisberg Campus
Leuven, , Belgium
Centre Hospitalier Universitaire Sart Tilman
Liège, , Belgium
Medical Centre Artmed
Plovdiv, , Bulgaria
Multiprofile hospital for active treatment Kaspela EOOD
Plovdiv, , Bulgaria
Genge Partners
Montreal, , Canada
Ottawa Hospital Research Institute-Civic Campus
Ottawa, , Canada
Peking University First Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Xiangya Hospital Central South University
Changsha, , China
The Second Xiangya Hospital of Central South University
Changsha, , China
Sichuan Provincial Peoples Hospital
Chengdu, , China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, , China
Nanfang Hospital, Southern Medical University
Guangzhou, , China
The First Affiliated Hospital - School of Medicine - ZheJiang University
Hangzhou, , China
Anhui Provincial Hospital
Hefei, , China
The Second Affiliated Hospital Of Nanchang University
Nanchang, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Huashan Hospital Affiliated to Fudan University
Shanghai, , China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Shanghai Renji Hospital
Shanghai, , China
First Affiliated Hospital of Shanxi Medical College
Shanxi, , China
China Medical University (CMU) - First Affiliated Hospital
Shenyang, , China
Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital
Wuhan, , China
First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)-Zhengzhou University
Zhengzhou, , China
Cyprus Institute of Neurology and Genetics
Nicosia, , Cyprus
Revmatologicky ustav
Prague, , Czechia
Copenhagen University Hospital-Rigshospitalet University Hospital
Copenhagen, , Denmark
Hopital Edouard Herriot
Lyon, , France
Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix
Paris, , France
Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen
Rouen, , France
Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes
Strasbourg, , France
American Hospital Network
Tbilisi, , Georgia
LTD New Hospitals
Tbilisi, , Georgia
Aversi Clinic
Tbilisi, , Georgia
LLC MediClub Georgia
Tbilisi, , Georgia
The First Medical Center
Tbilisi, , Georgia
LTD Tbilisi Heart Center
Tbilisi, , Georgia
Charite - Universitaetsmedizin Berlin
Berlin, , Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Universitatsmedizin Gottingen - Georg-August-Universitat
Göttingen, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Rheumazentrum Ruhrgebiet
Herne, , Germany
Universitatsmedizin Mannheim
Mannheim, , Germany
Ludwig-Maximilians-Universitat Munchen Friedrich-Baur-Institut Neurologische Klinik und Poliklinik
München, , Germany
St. Josef-Stift Sendenhorst
Sendenhorst, , Germany
Universitaetsklinikum Tuebingen (UKT)
Tübingen, , Germany
Universitatsklinikum Ulm - Standort Oberer Eselsberg
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 General University Hospital
Athens, , Greece
Athens Medical Center
Athens, , Greece
University of Ioannina Medical School
Ioannina, , Greece
Semmelweis Egyetem, Institute of Genomic Medicine and Rare Disorders
Budapest, , Hungary
Debreceni Egyetem - University of Debrecen
Debrecen, , Hungary
St. Vincents University Hospital
Dublin, , Ireland
Connolly Hospital Blanchardstown
Dublin, , Ireland
North West Rheumatology Unit - Our Lady's Hospital
Manorhamilton, , Ireland
Bnai Zion Medical Center
Haifa, , Israel
Rambam Health Care Campus
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
Petah Tikva, , Israel
Sheba Medical Center - Rheumatology
Ramat Gan, , Israel
Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari - Rheumatology
Bari, , Italy
Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
Milan, , Italy
San Matteo Hospital
Pavia, , Italy
A.O. Universitaria Pisana
Pisa, , Italy
IRCCS Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Roma, , Italy
Azienda Ospedaliero Universitaria Sant'Andrea
Roma, , Italy
IRCCS Istituto Clinico Humanitas - Rheumatology
Rozzano, , Italy
Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette
Torino, , Italy
ASU FC - Presidio Ospedaliero Universitario Santa Maria della Misericordia
Udine, , Italy
Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma
Verona, , Italy
Tokyo Medical And Dental University Hospital, Faculty of Medicine
Bunkyō City, , Japan
Nippon Medical School - Nippon Medical School Hospital
Bunkyō City, , Japan
St. Marianna University School of Medicine Hospital
Kawasaki, , Japan
Kurume University Hospital
Kurume, , Japan
Chiba-Nishi General Hospital
Matsudo-shi, , Japan
Japan Community Healthcare Organization Chukyo Hospital
Nagoya, , Japan
Kitasato University Hospital (KUH)
Sagamihara-shi, , Japan
Sapporo City Hospital
Sapporo, , Japan
Hokkaido University Hospital - Rheumatology
Sapporo, , Japan
Sasebo Chuo Hospital
Sasebo-shi, , Japan
Tohoku University Hospital
Sendai, , Japan
Tokushima University Hospital
Tokushima, , Japan
Juntendo University Hospital - Rheumatology
Tokyo, , Japan
The University of Tokyo Hospital
Tokyo, , Japan
Keio University Hospital
Tokyo, , Japan
University of Tsukuba Hospital - Rheumatology
Tsukuba, , Japan
Yamaguchi University Hospital
Ube-shi, , Japan
Wakayama Medical University Hospital - Dermatology
Wakayama, , Japan
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, , Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, , Lithuania
CITER - Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S.A. de C.V.
Mexico City, , Mexico
Centro Peninsular De Investigacion Clinica
Mérida, , Mexico
Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)
Amsterdam, , Netherlands
Universitair Medisch Centrum Utrecht (UMC Utrecht)
Utrecht, , Netherlands
Hogar Clinica San Juan de Dios
Arequipa, , Peru
Investigaciones Clinicas S.A.C.
Lima, , Peru
Instituto Peruano Del Hueso Y La Articulacion Sac-Privado-Lima, Centro De Investigacion Iphar
Lima, , Peru
Hospital Nacional Cayetano Heredia
Lima, , Peru
Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113
Lodz, , Poland
Centrum Wsparcia Badan Klinicznych Pomorski Uniwersytet Medyczny w Szczecinie
Szczecin, , Poland
Centro Hospitalar Lisboa Norte, E.P.E- Hospital Santa Maria
Lisbon, , Portugal
Centro Hospitalar Universitario de Santo Antonio
Porto, , Portugal
Clinical Center of Serbia
Belgrade, , Serbia
Institute of Rheumatology
Belgrade, , Serbia
Narodny ustav reumatickych chorob
Piešťany, , Slovakia
Chungnam National University Hospital (CNUH)
Daejeon, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Kyung Hee University Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Clinic de Barcelona - Sede Villarroel - Rheumatology
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital De Valme
Seville, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Hospital Do Meixoeiro
Vigo, , Spain
Karolinska Universitestssjukhus Solna
Stockholm, , Sweden
Neurocenter of Southern Switzerland
Lugano, , Switzerland
Chung Shan Medical University Hospital
Taichung, , Taiwan
China Medical University and Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Chulalongkorn University - Faculty of Medicine - King Chulalongkorn Memorial Hospital (KCMH)
Bangkok, , Thailand
Phramongkutklao Hospital
Bangkok, , Thailand
Ramathibodi hospital
Bangkok, , Thailand
Siriraj Hospital, Mahidol University of Internal medicine
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
Chiang Mai, , Thailand
Khon Kaen University
Khon Kaen, , Thailand
Thammasat University Hospital
Pathum Thani, , Thailand
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty
Konya, , Turkey (Türkiye)
Royal National Hospital for Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust
Bath, , United Kingdom
Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust
Doncaster, , United Kingdom
Leeds Institute of Rheumatic & Musculoskeletal Medicine - University of Leeds
Leeds, , United Kingdom
Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust
Liverpool, , United Kingdom
The Royal Free Hospital - Royal Free London NHS Foundation Trust
London, , United Kingdom
Kings College Hospital NHS Foundation Trust
London, , United Kingdom
The National Hospital for Neurology and Neurosurgery
London, , United Kingdom
James Cook University Hospital - South Tees Hospitals NHS Foundation Trust
Middlesbrough, , United Kingdom
Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
Salford, , United Kingdom
Countries
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Related Links
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Study website
Other Identifiers
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2024-512785-33-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARGX-113-2007
Identifier Type: -
Identifier Source: org_study_id
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