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

NCT ID NCT05979441

Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 study drug Exclusion Criteria: * 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 the study drug or 1 of its excipients * Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    92 sites in 29 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.