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A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
Sponsor: argenx
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).
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
2026-07-02
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
EFG PH20 SC
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
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