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ACTIVE NOT RECRUITING
NCT05523167
PHASE2/PHASE3

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

Sponsor: argenx

View on ClinicalTrials.gov

Summary

This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome \[ASyS\]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/.

Official title: A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

265

Start Date

2022-10-12

Completion Date

2027-02-01

Last Updated

2025-07-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

EFG PH20 SC

Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer

OTHER

PBO

Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer

Locations (202)

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