Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
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).

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

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

And 102 more locations on ClinicalTrials.gov