A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

September 12, 2023

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions
MyositisActive Idiopathic Inflammatory MyopathyDermatomyositisPolymyositisImmune-Mediated Necrotizing MyopathyAntisynthetase Syndrome
Interventions
BIOLOGICAL

EFG PH20 SC

Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer

Trial Locations (58)

27

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

168

Fondazione Policlinico Universitario Agostino Gemelli - Neurology, Roma

402

Chung Shan Medical University Hospital, Taichung

2100

Copenhagen University Hospital-Rigshospitalet University Hospital, Copenhagen

2371

Cyprus Institute of Neurology and Genetics, Nicosia

3000

Universitair Ziekenhuis Leuven Gasthuisberg Campus, Leuven

4000

Centro Medico Privado de Reumatologia, San Miguel de Tucumán

Clinica San Juan de Dios - sede Arequipa - Rheumatology, Arequipa

4002

Medical Centre Artmed, Plovdiv

6020

Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck - Neurology, Innsbruck

9000

AZ Sint-Lucas - Campus Sint-Lucas - Neurology, Ghent

10117

Charite Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Rheumatology, Berlin

10330

King Chulalongkorn Memorial Hospital - Neurology, Bangkok

10400

Phramongkutklao Hospital, Bangkok

10700

Siriraj Hospital, Mahidol University of Internal medicine, Bangkok

11000

Clinical Center of Serbia, Belgrade

Institute of Rheumatology, Belgrade

11021

Northwell Health Physician Partners Rheumatology, Great Neck

12462

ATTIKON University General Hospital - Neurology, Athens

12850

Revmatologicky Ustav, Prague

15261

University of Pittsburgh Medical Center, Pittsburgh

17176

Karolinska Universitestssjukhus Solna, Solna

20132

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

28041

Hospital Universitario 12 de Octubre, Madrid

30322

Emory Healthcare - Emory Clinic - Rheumatology, Atlanta

32224

Mayo Clinic - Florida - Neurology, Jacksonville

32610

UF Health - Rheumatology Medical Specialties Medical Plaza, Gainesville

40002

Faculty Of Medicine, Khon Kaen University, Khon Kaen

46026

Hospital Universitari i Politecnic La Fe de Valencia - Neurology, Valencia

56126

Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara - Rheumatology, Pisa

60611

Northwestern Medicine - Northwestern Memorial Hospital, Chicago

68167

Universitatsmedizin Mannheim GmbH, Mannheim

70124

Azienda Ospedaliero Universitaria Consorziale Policlinico, Bari

72076

Universitaetsklinikum Tuebingen (UKT), Tübingen

75013

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

77030

Nerve And Muscle Center Of Texas, Houston

78759

Austin Neuromuscular Center (National Neuromuscular Research Institute, PLLC), Austin

85028

Neuromuscular Clinical and Research Center - Neurology, Phoenix

89081

Klinikum der Universitaet Ulm, Ulm

90039

Attune Health Research, Inc, Beverly Hills

92868

UCI Health - ALS and Neuromuscular Center - Neurology, Orange

94143

UCSF Health - ALS and Neurodegenerative Disease Center - Dermatology, San Francisco

97239

Oregon Health and Science University, Portland

B1663GKT

Centro Dermatologico Schejtman, San Miguel

0160

Aversi Clinic, Tbilisi

LLC MediClub Georgia, Tbilisi

0162

New Hospitals, Tbilisi

0180

The First Medical Center, Tbilisi

115 28

National and Kapodistrian University of Athens - Eginition Hospital, Athens

113-8655

The University of Tokyo Hospital, Bunkyō City

08410

Santaros University Clinic, Vilnius

1105 AZ

Amsterdam UMC Research BV, Amsterdam

90-549

USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113 - Rheumatology, Lodz

71-252

Centrum Wsparcia Badan Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie (CWBK PUM) - Rheumatology, Szczecin

4099-001

Centro Hospitalar do Porto - Hospital Santo Antonio, Porto

03080

Seoul National University Hospital, Seoul

NW3 2QG

The Royal Free Hospital, London

M6 8HD

Northern Care Allicance NHS Foundation Trust - Salford Royal - Rheumatology, Salford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

argenx

INDUSTRY