Can a targeted immune drug calm rare muscle inflammation?

NCT ID NCT05523167

First seen Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial tests whether efgartigimod, an injected drug that blocks certain immune antibodies, can improve muscle strength and function in adults with active idiopathic inflammatory myopathy — a group of rare autoimmune diseases that cause muscle inflammation and weakness. About 265 participants with subtypes like dermatomyositis or polymyositis will receive either the drug or a placebo. The main goal is to see if the drug leads to meaningful clinical improvement.

What this could mean

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

Active substance
an experimental drug called efgartigimod, given as a shot under the skin
What this could lead to
If it works, this could offer a new treatment option for people with rare inflammatory muscle diseases that cause weakness and disability.
What could go wrong
This is an early-to-mid-stage trial, so the drug may not prove effective or safe enough. Side effects from immune suppression are possible.

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.

As listed by the trial registrant

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

Contacts and locations

Locations

  • A.O. Universitaria Pisana

    Pisa, 56126, Italy

  • ASU FC - Presidio Ospedaliero Universitario Santa Maria della Misericordia

    Udine, 33100, Italy

  • AZ Sint Lucas Gent-Campus Sint Lucas

    Ghent, 9000, Belgium

  • Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust

    Liverpool, L9 7AL, United Kingdom

  • Ajou University Hospital

    Suwon, 16499, South Korea

  • Allgemeines Krankenhaus der Stadt Wien (AKH Wien)

    Vienna, 1090, Austria

  • American Hospital Network

    Tbilisi, 0102, Georgia

  • Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)

    Amsterdam, 1105 AZ, Netherlands

  • Amyotrophic Lateral Sclerosis (ALS) Treatment Center,University of California San Francisco (UCSF)

    San Francisco, California, 94143-2202, United States

  • Anhui Provincial Hospital

    Hefei, 230001, China

  • Ankara City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Ankara University Medical Faculty

    Ankara, 06230, Turkey (Türkiye)

  • Athens Medical Center

    Athens, 151 25, Greece

  • Attikon General University Hospital

    Athens, 12462, Greece

  • Attune Health Research, Inc

    Beverly Hills, California, 90039, United States

  • Augusta University

    Augusta, Georgia, 30312, United States

  • Austin Neuromuscular Center

    Austin, Texas, 78759, United States

  • Aversi Clinic

    Tbilisi, 0160, Georgia

  • Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma

    Verona, 37134, Italy

  • Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari - Rheumatology

    Bari, 70124, Italy

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50139, Italy

  • Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette

    Torino, 10126, Italy

  • Azienda Ospedaliero Universitaria Sant'Andrea

    Roma, 00189, Italy

  • Bnai Zion Medical Center

    Haifa, 31048, Israel

  • CITER - Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S.A. de C.V.

    Mexico City, 06700, Mexico

  • California Pacific Medical Center - Sutter Health

    San Francisco, California, 94109, United States

  • Carolina Arthritis Associates

    Wilmington, North Carolina, 28401, United States

  • Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen

    Rouen, 76031, France

  • Centre Hospitalier Universitaire Sart Tilman

    Liège, 4000, Belgium

  • Centre Hospitalier Universitaire de Charleroi

    Charleroi, 6042, Belgium

  • Centro Dermatologico Schejtman

    San Miguel, B1663GKT, Argentina

  • Centro Hospitalar Lisboa Norte, E.P.E- Hospital Santa Maria

    Lisbon, 1649-035, Portugal

  • Centro Hospitalar Universitario de Santo Antonio

    Porto, 4099-001, Portugal

  • Centro Peninsular De Investigacion Clinica

    Mérida, 97000, Mexico

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, T4000AXL, Argentina

  • Centrum Wsparcia Badan Klinicznych Pomorski Uniwersytet Medyczny w Szczecinie

    Szczecin, 71-252, Poland

  • Charite - Universitaetsmedizin Berlin

    Berlin, 10117, Germany

  • Chiba-Nishi General Hospital

    Matsudo-shi, 270-2251, Japan

  • China Medical University (CMU) - First Affiliated Hospital

    Shenyang, 110001, China

  • China Medical University and Hospital

    Taichung, 40402, Taiwan

  • Chulalongkorn University - Faculty of Medicine - King Chulalongkorn Memorial Hospital (KCMH)

    Bangkok, 10300, Thailand

  • Chung Shan Medical University Hospital

    Taichung, 402, Taiwan

  • Chungnam National University Hospital (CNUH)

    Daejeon, 35015, South Korea

  • Cleveland Clinic - Main Campus

    Cleveland, Ohio, 44195, United States

  • Clinical Center of Serbia

    Belgrade, 11000, Serbia

  • Connolly Hospital Blanchardstown

    Dublin, D15 X40D, Ireland

  • Consultora Integral de Salud

    Córdoba, 5000, Argentina

  • Copenhagen University Hospital-Rigshospitalet University Hospital

    Copenhagen, 2100, Denmark

  • Cyprus Institute of Neurology and Genetics

    Nicosia, 2371, Cyprus

  • Debreceni Egyetem - University of Debrecen

    Debrecen, 4032, Hungary

  • Denver Arthritis Clinic

    Denver, Colorado, 80230, United States

  • Dim Clinica Privada

    Ramos Mejía, B1704ETD, Argentina

  • Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust

    Doncaster, DN2 5LT, United Kingdom

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270, United States

  • Emory University Hospital, The Emory Clinic

    Atlanta, Georgia, 30322, United States

  • Fiona Stanley Hospital

    Murdoch, 6150, Australia

  • First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)-Zhengzhou University

    Zhengzhou, 450052, China

  • First Affiliated Hospital of Shanxi Medical College

    Shanxi, 30001, China

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    Roma, 00168, Italy

  • Framingham Centro Medico

    La Plata, B1902COS, Argentina

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Genge Partners

    Montreal, H4A 3T2, Canada

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Hanyang University Seoul Hospital

    Seoul, 04763, South Korea

  • Harvard Medical School - Brigham and Women's Hospital (BWH) - The Schuster Family Transplantation Research Center (TRC)

    Boston, Massachusetts, 02115-6110, United States

  • Hogar Clinica San Juan de Dios

    Arequipa, 4018, Peru

  • Hokkaido University Hospital - Rheumatology

    Sapporo, 060-8648, Japan

  • HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology

    Scottsdale, Arizona, 85251, United States

  • Hopital Edouard Herriot

    Lyon, 69003, France

  • Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes

    Strasbourg, 67098, France

  • Hospital Clinic de Barcelona - Sede Villarroel - Rheumatology

    Barcelona, 08036, Spain

  • Hospital De Valme

    Seville, 9-41014, Spain

  • Hospital Do Meixoeiro

    Vigo, 36200, Spain

  • Hospital General Universitario de Alicante

    Alicante, 03010, Spain

  • Hospital Nacional Cayetano Heredia

    Lima, 31, Peru

  • Hospital Universitario 12 de Octubre

    Madrid, 451086, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas, 50161, Lithuania

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, 200000, China

  • Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital

    Wuhan, 430030, China

  • IRCCS Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123, Italy

  • IRCCS Istituto Clinico Humanitas - Rheumatology

    Rozzano, 20089, Italy

  • Institute of Rheumatology

    Belgrade, 11000, Serbia

  • Instituto Peruano Del Hueso Y La Articulacion Sac-Privado-Lima, Centro De Investigacion Iphar

    Lima, 27, Peru

  • Investigaciones Clinicas S.A.C.

    Lima, 15023, Peru

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital

    Milan, 20132, Italy

  • James Cook University Hospital - South Tees Hospitals NHS Foundation Trust

    Middlesbrough, TS4 3BW, United Kingdom

  • Japan Community Healthcare Organization Chukyo Hospital

    Nagoya, 457-8510, Japan

  • Johns Hopkins Medicine - Johns Hopkins Myositis Center

    Baltimore, Maryland, 21224, United States

  • Juntendo University Hospital - Rheumatology

    Tokyo, 113-8431, Japan

  • Karolinska Universitestssjukhus Solna

    Stockholm, 17164, Sweden

  • Keio University Hospital

    Tokyo, 160-8582, Japan

  • Khon Kaen University

    Khon Kaen, 40000, Thailand

  • Kings College Hospital NHS Foundation Trust

    London, SE5 9RS, United Kingdom

  • Kitasato University Hospital (KUH)

    Sagamihara-shi, 252-0375, Japan

  • Kurume University Hospital

    Kurume, 830-0011, Japan

  • Kyung Hee University Medical Center

    Seoul, 02447, South Korea

  • LLC MediClub Georgia

    Tbilisi, 0179, Georgia

  • LTD New Hospitals

    Tbilisi, 0114, Georgia

  • LTD Tbilisi Heart Center

    Tbilisi, 0186, Georgia

  • Leeds Institute of Rheumatic & Musculoskeletal Medicine - University of Leeds

    Leeds, LS7 4SA, United Kingdom

  • Ludwig-Maximilians-Universitat Munchen Friedrich-Baur-Institut Neurologische Klinik und Poliklinik

    München, 80336, Germany

  • Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University

    Chiang Mai, 50200, Thailand

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • McGovern Medical School -The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • Medical Centre Artmed

    Plovdiv, 4002, Bulgaria

  • Medical University Innsbruck

    Innsbruck, 6020, Austria

  • Meir Medical Center

    Kfar Saba, 44281, Israel

  • Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology

    Oklahoma City, Oklahoma, 73120, United States

  • Michigan State University - Neurology

    East Lansing, Michigan, 48824, United States

  • Multiprofile hospital for active treatment Kaspela EOOD

    Plovdiv, 4002, Bulgaria

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515, China

  • Nanjing Drum Tower Hospital

    Nanjing, 210008, China

  • Narodny ustav reumatickych chorob

    Piešťany, 92112, Slovakia

  • 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

  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42090, Turkey (Türkiye)

  • Nerve And Muscle Center Of Texas

    Houston, Texas, 77030, United States

  • Neurocenter of Southern Switzerland

    Lugano, 6900, Switzerland

  • Neuromuscular Research Center

    Phoenix, Arizona, 85028, United States

  • Nippon Medical School - Nippon Medical School Hospital

    Bunkyō City, 113-8603, Japan

  • North West Rheumatology Unit - Our Lady's Hospital

    Manorhamilton, F91 X012, Ireland

  • Northwell Health

    Great Neck, New York, 11021, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Ottawa Hospital Research Institute-Civic Campus

    Ottawa, K1Y 4E9, Canada

  • Peking Union Medical College Hospital

    Beijing, 100730, China

  • Peking University First Hospital

    Beijing, 100034, China

  • Peking University Third Hospital

    Beijing, 100191, China

  • Phramongkutklao Hospital

    Bangkok, 10400, Thailand

  • Profound Research LLC - Oceanside

    Oceanside, California, 92056, United States

  • Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)

    Petah Tikva, 49100, Israel

  • Ramathibodi hospital

    Bangkok, 10400, Thailand

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix

    Paris, 75013, France

  • Revmatologicky ustav

    Prague, 128 00, Czechia

  • Rheumazentrum Ruhrgebiet

    Herne, 44649, Germany

  • Royal National Hospital for Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust

    Bath, BA1 3NG, United Kingdom

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200025, China

  • Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

    Salford, M6 8HD, United Kingdom

  • San Matteo Hospital

    Pavia, 27100, Italy

  • Sapporo City Hospital

    Sapporo, 060-8604, Japan

  • Sasebo Chuo Hospital

    Sasebo-shi, 857-1165, Japan

  • Semmelweis Egyetem, Institute of Genomic Medicine and Rare Disorders

    Budapest, 1083, Hungary

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shanghai Renji Hospital

    Shanghai, 200127, China

  • Sheba Medical Center - Rheumatology

    Ramat Gan, 52621, Israel

  • Sichuan Provincial Peoples Hospital

    Chengdu, 610072, China

  • Siriraj Hospital, Mahidol University of Internal medicine

    Bangkok, 10700, Thailand

  • St. Josef-Stift Sendenhorst

    Sendenhorst, 48324, Germany

  • St. Marianna University School of Medicine Hospital

    Kawasaki, 216-8511, Japan

  • St. Paul Rheumatology, PA

    Saint Paul, Minnesota, 55121, United States

  • St. Vincents University Hospital

    Dublin, D04 T6F4, Ireland

  • Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine

    Redwood City, California, 94063-3132, United States

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, 510000, China

  • Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168, Poland

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Thammasat University Hospital

    Pathum Thani, 12120, Thailand

  • The First Affiliated Hospital - School of Medicine - ZheJiang University

    Hangzhou, 310003, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The First Medical Center

    Tbilisi, 0180, Georgia

  • The National Hospital for Neurology and Neurosurgery

    London, WC1N 3BG, United Kingdom

  • The Ohio State University

    Columbus, Ohio, 43201, United States

  • The Royal Free Hospital - Royal Free London NHS Foundation Trust

    London, NW3 2QG, United Kingdom

  • The Second Affiliated Hospital Of Nanchang University

    Nanchang, 330000, China

  • The Second Xiangya Hospital of Central South University

    Changsha, 410011, China

  • The University of Tokyo Hospital

    Tokyo, 113-8655, Japan

  • The Wesley Medical Research

    Auchenflower, 4066, Australia

  • Tohoku University Hospital

    Sendai, 980-8574, Japan

  • Tokushima University Hospital

    Tokushima, 770-8503, Japan

  • Tokyo Medical And Dental University Hospital, Faculty of Medicine

    Bunkyō City, 113-8519, Japan

  • UF Health Rheumatology

    Gainesville, Florida, 32610-3008, United States

  • USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113

    Lodz, 90-549, Poland

  • Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225, Germany

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitaetsklinikum Tuebingen (UKT)

    Tübingen, 72076, Germany

  • Universitair Medisch Centrum Utrecht (UMC Utrecht)

    Utrecht, 3584 CX, Netherlands

  • Universitair Ziekenhuis Leuven Gasthuisberg Campus

    Leuven, 3000, Belgium

  • Universitatsklinikum Ulm - Standort Oberer Eselsberg

    Ulm, 89081, Germany

  • Universitatsmedizin Gottingen - Georg-August-Universitat

    Göttingen, 37075, Germany

  • Universitatsmedizin Mannheim

    Mannheim, 68167, Germany

  • University Of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of California, Irvine

    Orange, California, 92868, United States

  • University of Ioannina Medical School

    Ioannina, 45110, Greece

  • University of North Carolina (UNC) School of Medicine

    Chapel Hill, North Carolina, 27514-4220, United States

  • University of Pittsburg 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

  • University of Southern California Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University of Tsukuba Hospital - Rheumatology

    Tsukuba, 305-8576, Japan

  • University of Vermont Medical Center - Main Campus

    Burlington, Vermont, 05401, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic

    Nashville, Tennessee, 37232-0028, United States

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, 08661, Lithuania

  • Wakayama Medical University Hospital - Dermatology

    Wakayama, 641-8509, Japan

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Xiangya Hospital Central South University

    Changsha, 410008, China

  • Yale Cancer Center-Yale University School Of Medicine

    New Haven, Connecticut, 06520, United States

  • Yamaguchi University Hospital

    Ube-shi, 755-8505, Japan

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