New drug shows promise for Long-Term control of rare muscle disease

NCT ID NCT05979441

ENROLLING_BY_INVITATION Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This study tests the long-term safety of a drug called efgartigimod PH20 SC in adults with active idiopathic inflammatory myopathy, a group of rare muscle diseases. Participants who completed a previous trial will receive the drug as a shot under the skin for up to 51 months. The goal is to see if the drug remains safe and helps control the disease over time.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: efgartigimod PH20 SC (a biologic drug given as a shot under the skin)
What this could lead to: If it works, this could provide a long-term treatment option to control myositis, reducing symptoms and the need for steroids.
What could go wrong: This is an open-label extension study with no placebo group, so results may be less reliable. Long-term safety is still being evaluated, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy antisynthetase syndrome dermatomyositis idiopathic inflammatory myopathy immune-mediated necrotizing myopathy juvenile dermatomyositis myositis disease polymyositis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHY ANTISYNTHETASE SYNDROME DERMATOMYOSITIS IMMUNE-MEDIATED NECROTIZING MYOPATHY MYOSITIS POLYMYOSITIS

Contacts and locations

Locations

ATTIKON University General Hospital - Neurology

Athens, 12462, Greece
AZ Sint-Lucas - Campus Sint-Lucas - Neurology

Ghent, 9000, Belgium
Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust

Liverpool, L9 7AL, United Kingdom
Amsterdam UMC Research BV

Amsterdam, 1105 AZ, Netherlands
Attune Health Research, Inc

Beverly Hills, California, 90039, United States
Austin Neuromuscular Center (National Neuromuscular Research Institute, PLLC)

Austin, Texas, 78759, United States
Aversi Clinic

Tbilisi, 0160, Georgia
Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, 70124, Italy
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara - Rheumatology

Pisa, 56126, Italy
Azienda sanitaria universitaria Friuli Centrale - ASUFC

Udine, 33100, Italy
Centro Dermatologico Schejtman

San Miguel, B1663GKT, Argentina
Centro Hospitalar do Porto - Hospital Santo Antonio

Porto, 4099-001, Portugal
Centro Medico Privado de Reumatologia

San Miguel de Tucumán, 4000, Argentina
Centrum Wsparcia Badan Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie (CWBK PUM) - Rheumatology

Szczecin, 71-252, Poland
Charite Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Rheumatology

Berlin, 10117, Germany
China Medical University (CMU) - First Affiliated Hospital

Shenyang, 110001, China
Chung Shan Medical University Hospital

Taichung, 402, Taiwan
Clinica San Juan de Dios - sede Arequipa - Rheumatology

Arequipa, 4000, Peru
Clinical Center of Serbia

Belgrade, 11000, Serbia
Copenhagen University Hospital-Rigshospitalet University Hospital

Copenhagen, 2100, Denmark
Cyprus Institute of Neurology and Genetics

Nicosia, 2371, Cyprus
Emory Healthcare - Emory Clinic - Rheumatology

Atlanta, Georgia, 30322, United States
Faculty Of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand
First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)-Zhengzhou University

Zhengzhou, 450052, China
Fondazione Policlinico Universitario Agostino Gemelli - Neurology

Roma, 168, Italy
Framingham Centro Medico

La Plata, B1902COS, Argentina
Hospital Angeles Clinica Londres

Mexico City, 06700, Mexico
Hospital Universitari i Politecnic La Fe de Valencia - Neurology

Valencia, 46026, Spain
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain
Huashan Hospital Affiliated to Fudan University

Shanghai, 200040, China
IRCCS Istituto Clinico Humanitas

Rozzano, 20089, Italy
Institute of Rheumatology

Belgrade, 11000, Serbia
Institute of Science Tokyo Hospital

Tokyo, 113-8519, Japan
Instituto Peruano Del Hueso Y La Articulacion Sac-Privado-Lima,Centro De Investigacion Iphar

Lima, 27, Peru
Investigaciones Clinicas S.A.C.

Lima, 33, Peru
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital

Milan, 20132, Italy
Japan Community Healthcare Organization Chukyo Hospital

Nagoya, 457-8510, Japan
John Hopkins Medicine - Johns Hopkins Myositis Center

Baltimore, Maryland, 21224-2734, United States
Juntendo University Hospital

Bunkyō City, 113-8431, Japan
Karolinska Universitestssjukhus Solna

Solna, 17176, Sweden
King Chulalongkorn Memorial Hospital - Neurology

Bangkok, 10330, Thailand
Klinikum der Universitaet Ulm

Ulm, 89081, Germany
LLC MediClub Georgia

Tbilisi, 0160, Georgia
Mayo Clinic - Florida - Neurology

Jacksonville, Florida, 32224, United States
Medical Centre Artmed

Plovdiv, 4002, Bulgaria
Multiprofile hospital for active treatment Kaspela EOOD

Plovdiv, 4002, Bulgaria
Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China
Nanjing University Medical School - Taikang Xianlin Drum Tower Hospital (Nanjing Drum Tower Hospital)

Nanjing, Jingsu, 210000, China
National and Kapodistrian University of Athens - Eginition Hospital

Athens, 115 28, Greece
National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine

Athens, 115 27, Greece
Nerve And Muscle Center Of Texas

Houston, Texas, 77030, United States
Neuromuscular Clinical and Research Center - Neurology

Phoenix, Arizona, 85028, United States
New Hospitals

Tbilisi, 0162, Georgia
Northern Care Allicance NHS Foundation Trust - Salford Royal - Rheumatology

Salford, M6 8HD, United Kingdom
Northwell Health Physician Partners Rheumatology

Great Neck, New York, 11021, United States
Northwestern Medicine - Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States
Oregon Health and Science University

Portland, Oregon, 97239, United States
Ospedale Sant'Andrea Hospital

Roma, 00189, Italy
Peking Union Medical College Hospital

Beijing, 100730, China
Peking University Third Hospital

Beijing, 100191, China
Phramongkutklao Hospital

Bangkok, 10400, Thailand
Ramathibodi hospital

Bangkok, 10400, Thailand
Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix

Paris, 75013, France
Revmatologicky Ustav

Prague, 12850, Czechia
Rheumazentrum Ruhrgebiet

Herne, 44649, Germany
Santaros University Clinic

Vilnius, 08410, Lithuania
Seoul National University Hospital

Seoul, 03080, South Korea
Shanghai Jiao Tong University School of Medicine - Renji Hospital - Shanghai Institute of Digestive Disease (SIDD)

Shanghai, 200001, China
Sichuan Provincial Academy of Medical Sciences and Sichuan Provincial People's Hospital

Chengdu, 610072, China
Siriraj Hospital, Mahidol University of Internal medicine

Bangkok, 10700, Thailand
Taichung Veterans General Hospital

Taichung, Taiwan
The First Medical Center

Tbilisi, 0180, Georgia
The Ohio State University

Columbus, Ohio, 43201, United States
The Royal Free Hospital

London, NW3 2QG, United Kingdom
The University of Tokyo Hospital

Bunkyō City, 113-8655, Japan
Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck - Neurology

Innsbruck, 6020, Austria
UCI Health - ALS and Neuromuscular Center - Neurology

Orange, California, 92868, United States
UCSF Health - ALS and Neurodegenerative Disease Center - Dermatology

San Francisco, California, 94143, United States
UF Health - Rheumatology Medical Specialties Medical Plaza

Gainesville, Florida, 32610, United States
USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113 - Rheumatology

Lodz, 90-549, Poland
Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany
Universitaetsklinikum Tuebingen (UKT)

Tübingen, 72076, Germany
Universitair Ziekenhuis Leuven Gasthuisberg Campus

Leuven, 3000, Belgium
Universitatsmedizin Mannheim GmbH

Mannheim, 68167, Germany
University College Dublin (UCD) - St. Vincent's University Hospital (SVUH)

Dublin, D04 T6F4, Ireland
University of North Carolina (UNC) School of Medicine

Chapel Hill, North Carolina, 27514, United States
University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States
University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)

Tampa, Florida, 33616, United States
Wakayama Medical University Hospital

Wakayama, 641-8510, Japan
Yale Cancer Center-Yale University School Of Medicine

New Haven, Connecticut, 06520, United States
Yamaguchi University Hospital

Yamaguchi, 755-8505, Japan

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