A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy. | NCT05523167 | Trialant

A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy. | NCT05523167 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Ability to consent in the jurisdiction in which the study is taking place and capable of giving signed informed consent.

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:

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

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

Participant is pregnant or lactating or intends to become pregnant during the study.

Neuromuscular Research Center

Phoenix, Arizona 85028, United States

HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology

Scottsdale, Arizona 85251, United States

Attune Health Research, Inc

Beverly Hills, California 90039, United States

University of Southern California Norris Comprehensive Cancer Center

Los Angeles, California 90033, United States

Profound Research LLC - Oceanside

Oceanside, California 92056, United States

University of California, Irvine

Orange, California 92868, United States

Eisenhower Medical Center

Rancho Mirage, California 92270, United States

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

Redwood City, California 94063-3132, United States

California Pacific Medical Center - Sutter Health

San Francisco, California 94109, United States

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

San Francisco, California 94143-2202, United States

Denver Arthritis Clinic

Denver, Colorado 80230, United States

Yale Cancer Center-Yale University School Of Medicine

New Haven, Connecticut 06520, United States

Georgetown University Hospital

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

UF Health Rheumatology

Gainesville, Florida 32610-3008, United States

Mayo Clinic

Jacksonville, Florida 32224, United States

University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)

Tampa, Florida 33616, United States

Emory University Hospital, The Emory Clinic

Atlanta, Georgia 30322, United States

Augusta University

Augusta, Georgia 30312, United States

Northwestern Memorial Hospital

Chicago, Illinois 60611, United States

University Of Kansas Medical Center

Kansas City, Kansas 66160, United States

Johns Hopkins Medicine - Johns Hopkins Myositis Center

Baltimore, Maryland 21224, United States

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

Boston, Massachusetts 02115-6110, United States

Michigan State University - Neurology

East Lansing, Michigan 48824, United States

St. Paul Rheumatology, PA

Saint Paul, Minnesota 55121, United States

Washington University School of Medicine

St Louis, Missouri 63110, United States

Northwell Health

Great Neck, New York 11021, United States

Hospital for Special Surgery

New York, New York 10021, United States

University of North Carolina (UNC) School of Medicine

Chapel Hill, North Carolina 27514-4220, United States

Carolina Arthritis Associates

Wilmington, North Carolina 28401, United States

Cleveland Clinic - Main Campus

Cleveland, Ohio 44195, United States

The Ohio State University

Columbus, Ohio 43201, United States

Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology

Oklahoma City, Oklahoma 73120, United States

Oregon Health and Science University

Portland, Oregon 97239, United States

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania 15261, United States

Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic

Nashville, Tennessee 37232-0028, United States

Austin Neuromuscular Center

Austin, Texas 78759, United States

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

Houston, Texas 77030, United States

Nerve And Muscle Center Of Texas

Houston, Texas 77030, United States

University of Vermont Medical Center - Main Campus

Burlington, Vermont 05401, United States

University of Washington Medical Center

Seattle, Washington 98195, United States

Consultora Integral de Salud

Córdoba, 5000, Argentina

Framingham Centro Medico

La Plata, B1902COS, Argentina

Dim Clinica Privada

Ramos Mejía, B1704ETD, Argentina

Centro Dermatologico Schejtman

San Miguel, B1663GKT, Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, T4000AXL, Argentina

The Wesley Medical Research

Auchenflower, 4066, Australia

Fiona Stanley Hospital

Murdoch, 6150, Australia

Medical University Innsbruck

Innsbruck, 6020, Austria

Allgemeines Krankenhaus der Stadt Wien (AKH Wien)

Vienna, 1090, Austria

Centre Hospitalier Universitaire de Charleroi

Charleroi, 6042, Belgium

AZ Sint Lucas Gent-Campus Sint Lucas

Ghent, 9000, Belgium

Universitair Ziekenhuis Leuven Gasthuisberg Campus

Leuven, 3000, Belgium

Centre Hospitalier Universitaire Sart Tilman

Liège, 4000, Belgium

Medical Centre Artmed

Plovdiv, 4002, Bulgaria

Multiprofile hospital for active treatment Kaspela EOOD

Plovdiv, 4002, Bulgaria

Genge Partners

Montreal, H4A 3T2, Canada

Ottawa Hospital Research Institute-Civic Campus

Ottawa, K1Y 4E9, Canada

Peking University First Hospital

Beijing, 100034, China

Peking University Third Hospital

Beijing, 100191, China

Peking Union Medical College Hospital

Beijing, 100730, China

The First Hospital of Jilin University

Changchun, 130021, China

Xiangya Hospital Central South University

Changsha, 410008, China

The Second Xiangya Hospital of Central South University

Changsha, 410011, China

Sichuan Provincial Peoples Hospital

Chengdu, 610072, China

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

Guangzhou, 510000, China

Nanfang Hospital, Southern Medical University

Guangzhou, 510515, China

The First Affiliated Hospital - School of Medicine - ZheJiang University

Hangzhou, 310003, China

Anhui Provincial Hospital

Hefei, 230001, China

The Second Affiliated Hospital Of Nanchang University

Nanchang, 330000, China

Nanjing Drum Tower Hospital

Nanjing, 210008, China

Huashan Hospital Affiliated to Fudan University

Shanghai, 200000, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

Shanghai Renji Hospital

Shanghai, 200127, China

First Affiliated Hospital of Shanxi Medical College

Shanxi, 30001, China

China Medical University (CMU) - First Affiliated Hospital

Shenyang, 110001, China

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

Wuhan, 430030, China

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

Zhengzhou, 450052, China

Cyprus Institute of Neurology and Genetics

Nicosia, 2371, Cyprus

Revmatologicky ustav

Prague, 128 00, Czechia

Copenhagen University Hospital-Rigshospitalet University Hospital

Copenhagen, 2100, Denmark

Hopital Edouard Herriot

Lyon, 69003, France

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

Paris, 75013, France

Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen

Rouen, 76031, France

Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes

Strasbourg, 67098, France

American Hospital Network

Tbilisi, 0102, Georgia

LTD New Hospitals

Tbilisi, 0114, Georgia

Aversi Clinic

Tbilisi, 0160, Georgia

LLC MediClub Georgia

Tbilisi, 0179, Georgia

The First Medical Center

Tbilisi, 0180, Georgia

LTD Tbilisi Heart Center

Tbilisi, 0186, Georgia

Charite - Universitaetsmedizin Berlin

Berlin, 10117, Germany

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

Universitatsmedizin Gottingen - Georg-August-Universitat

Göttingen, 37075, Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Rheumazentrum Ruhrgebiet

Herne, 44649, Germany

Universitatsmedizin Mannheim

Mannheim, 68167, Germany

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

München, 80336, Germany

St. Josef-Stift Sendenhorst

Sendenhorst, 48324, Germany

Universitaetsklinikum Tuebingen (UKT)

Tübingen, 72076, Germany

Universitatsklinikum Ulm - Standort Oberer Eselsberg

Ulm, 89081, Germany

National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine

Athens, 115 27, Greece

National and Kapodistrian University of Athens - Eginition Hospital

Athens, 115 28, Greece

Attikon General University Hospital

Athens, 12462, Greece

Athens Medical Center

Athens, 151 25, Greece

University of Ioannina Medical School

Ioannina, 45110, Greece

Semmelweis Egyetem, Institute of Genomic Medicine and Rare Disorders

Budapest, 1083, Hungary

Debreceni Egyetem - University of Debrecen

Debrecen, 4032, Hungary

St. Vincents University Hospital

Dublin, D04 T6F4, Ireland

Connolly Hospital Blanchardstown

Dublin, D15 X40D, Ireland

North West Rheumatology Unit - Our Lady's Hospital

Manorhamilton, F91 X012, Ireland

Bnai Zion Medical Center

Haifa, 31048, Israel

Rambam Health Care Campus

Haifa, 3109601, Israel

Meir Medical Center

Kfar Saba, 44281, Israel

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

Petah Tikva, 49100, Israel

Sheba Medical Center - Rheumatology

Ramat Gan, 52621, Israel

Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari - Rheumatology

Bari, 70124, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, 50139, Italy

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

Milan, 20132, Italy

San Matteo Hospital

Pavia, 27100, Italy

A.O. Universitaria Pisana

Pisa, 56126, Italy

IRCCS Arcispedale Santa Maria Nuova

Reggio Emilia, 42123, Italy

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

Roma, 00168, Italy

Azienda Ospedaliero Universitaria Sant'Andrea

Roma, 00189, Italy

IRCCS Istituto Clinico Humanitas - Rheumatology

Rozzano, 20089, Italy

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

Torino, 10126, Italy

ASU FC - Presidio Ospedaliero Universitario Santa Maria della Misericordia

Udine, 33100, Italy

Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma

Verona, 37134, Italy

Tokyo Medical And Dental University Hospital, Faculty of Medicine

Bunkyō City, 113-8519, Japan

Nippon Medical School - Nippon Medical School Hospital

Bunkyō City, 113-8603, Japan

St. Marianna University School of Medicine Hospital

Kawasaki, 216-8511, Japan

Kurume University Hospital

Kurume, 830-0011, Japan

Chiba-Nishi General Hospital

Matsudo-shi, 270-2251, Japan

Japan Community Healthcare Organization Chukyo Hospital

Nagoya, 457-8510, Japan

Kitasato University Hospital (KUH)

Sagamihara-shi, 252-0375, Japan

Sapporo City Hospital

Sapporo, 060-8604, Japan

Hokkaido University Hospital - Rheumatology

Sapporo, 060-8648, Japan

Sasebo Chuo Hospital

Sasebo-shi, 857-1165, Japan

Tohoku University Hospital

Sendai, 980-8574, Japan

Tokushima University Hospital

Tokushima, 770-8503, Japan

Juntendo University Hospital - Rheumatology

Tokyo, 113-8431, Japan

The University of Tokyo Hospital

Tokyo, 113-8655, Japan

Keio University Hospital

Tokyo, 160-8582, Japan

University of Tsukuba Hospital - Rheumatology

Tsukuba, 305-8576, Japan

Yamaguchi University Hospital

Ube-shi, 755-8505, Japan

Wakayama Medical University Hospital - Dermatology

Wakayama, 641-8509, Japan

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, 50161, Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, 08661, Lithuania

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

Mexico City, 06700, Mexico

Centro Peninsular De Investigacion Clinica

Mérida, 97000, Mexico

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

Amsterdam, 1105 AZ, Netherlands

Universitair Medisch Centrum Utrecht (UMC Utrecht)

Utrecht, 3584 CX, Netherlands

Hogar Clinica San Juan de Dios

Arequipa, 4018, Peru

Investigaciones Clinicas S.A.C.

Lima, 15023, Peru

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

Lima, 27, Peru

Hospital Nacional Cayetano Heredia

Lima, 31, Peru

Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, 85-168, Poland

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

Lodz, 90-549, Poland

Centrum Wsparcia Badan Klinicznych Pomorski Uniwersytet Medyczny w Szczecinie

Szczecin, 71-252, Poland

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

Lisbon, 1649-035, Portugal

Centro Hospitalar Universitario de Santo Antonio

Porto, 4099-001, Portugal

Clinical Center of Serbia

Belgrade, 11000, Serbia

Institute of Rheumatology

Belgrade, 11000, Serbia

Narodny ustav reumatickych chorob

Piešťany, 92112, Slovakia

Chungnam National University Hospital (CNUH)

Daejeon, 35015, South Korea

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Kyung Hee University Medical Center

Seoul, 02447, South Korea

Seoul National University Hospital

Seoul, 03080, South Korea

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

Ajou University Hospital

Suwon, 16499, South Korea

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Hospital Clinic de Barcelona - Sede Villarroel - Rheumatology

Barcelona, 08036, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

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

Madrid, 28046, Spain

Hospital Universitario 12 de Octubre

Madrid, 451086, Spain

Hospital De Valme

Seville, 9-41014, Spain

Hospital Universitario y Politecnico La Fe

Valencia, 46026, Spain

Hospital Do Meixoeiro

Vigo, 36200, Spain

Karolinska Universitestssjukhus Solna

Stockholm, 17164, Sweden

Neurocenter of Southern Switzerland

Lugano, 6900, Switzerland

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

China Medical University and Hospital

Taichung, 40402, Taiwan

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

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

Bangkok, 10300, Thailand

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Ramathibodi hospital

Bangkok, 10400, Thailand

Siriraj Hospital, Mahidol University of Internal medicine

Bangkok, 10700, Thailand

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University

Chiang Mai, 50200, Thailand

Khon Kaen University

Khon Kaen, 40000, Thailand

Thammasat University Hospital

Pathum Thani, 12120, Thailand

Ankara University Medical Faculty

Ankara, 06230, Turkey (Türkiye)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Necmettin Erbakan University Meram Medical Faculty

Konya, 42090, Turkey (Türkiye)

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

Bath, BA1 3NG, United Kingdom

Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust

Doncaster, DN2 5LT, United Kingdom

Leeds Institute of Rheumatic & Musculoskeletal Medicine - University of Leeds

Leeds, LS7 4SA, United Kingdom

Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust

Liverpool, L9 7AL, United Kingdom

The Royal Free Hospital - Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Kings College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

The National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

James Cook University Hospital - South Tees Hospitals NHS Foundation Trust

Middlesbrough, TS4 3BW, United Kingdom

Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

Salford, M6 8HD, United Kingdom