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

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

265

Participants

Timeline

Start Date

October 12, 2022

Primary Completion Date

December 1, 2026

Study Completion Date

February 1, 2027

Conditions
Active Idiopathic Inflammatory MyopathyMyositisDermatomyositisPolymyositisImmune-Mediated Necrotizing MyopathyAntisynthetase Syndrome
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

Trial Locations (202)

27

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

31

Hospital Nacional Cayetano Heredia, Lima

402

Chung Shan Medical University Hospital, Taichung

1083

Semmelweis Egyetem, Institute of Genomic Medicine and Rare Disorders, Budapest

1090

Allgemeines Krankenhaus der Stadt Wien (AKH Wien), Vienna

2100

Copenhagen University Hospital-Rigshospitalet University Hospital, Copenhagen

2371

Cyprus Institute of Neurology and Genetics, Nicosia

3000

Universitair Ziekenhuis Leuven Gasthuisberg Campus, Leuven

4000

Centre Hospitalier Universitaire Sart Tilman, Liège

4002

Medical Centre Artmed, Plovdiv

Multiprofile hospital for active treatment Kaspela EOOD, Plovdiv

4018

Hogar Clinica San Juan de Dios, Arequipa

4032

Debreceni Egyetem - University of Debrecen, Debrecen

4066

The Wesley Medical Research, Auchenflower

5000

Consultora Integral de Salud, Córdoba

6020

Medical University Innsbruck, Innsbruck

6042

Centre Hospitalier Universitaire de Charleroi, Charleroi

6150

Fiona Stanley Hospital, Murdoch

6900

Neurocenter of Southern Switzerland, Lugano

9000

AZ Sint Lucas Gent-Campus Sint Lucas, Ghent

10021

Hospital for Special Surgery, New York

10117

Charite - Universitaetsmedizin Berlin, Berlin

10126

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

10300

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

10400

Phramongkutklao Hospital, Bangkok

Ramathibodi hospital, Bangkok

10700

Siriraj Hospital, Mahidol University of Internal medicine, Bangkok

11000

Clinical Center of Serbia, Belgrade

Institute of Rheumatology, Belgrade

11021

Northwell Health, Great Neck

12120

Thammasat University Hospital, Pathum Thani

12462

Attikon General University Hospital, Athens

15023

Investigaciones Clinicas S.A.C., Lima

15261

University of Pittsburg Medical Center, Pittsburgh

16499

Ajou University Hospital, Suwon

17164

Karolinska Universitestssjukhus Solna, Stockholm

20007

Georgetown University Hospital, Washington D.C.

20089

IRCCS Istituto Clinico Humanitas - Rheumatology, Rozzano

20132

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

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

21224

Johns Hopkins Medicine - Johns Hopkins Myositis Center, Baltimore

21565

Gachon University Gil Medical Center, Incheon

27100

San Matteo Hospital, Pavia

28034

Hospital Universitario Ramon y Cajal, Madrid

28046

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

28401

Carolina Arthritis Associates, Wilmington

30001

First Affiliated Hospital of Shanxi Medical College, Shanxi

30312

Augusta University, Augusta

30322

Emory University Hospital, The Emory Clinic, Atlanta

31048

Bnai Zion Medical Center, Haifa

32224

Mayo Clinic, Jacksonville

33100

ASU FC - Presidio Ospedaliero Universitario Santa Maria della Misericordia, Udine

33616

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

35015

Chungnam National University Hospital (CNUH), Daejeon

36200

Hospital Do Meixoeiro, Vigo

37075

Universitatsmedizin Gottingen - Georg-August-Universitat, Göttingen

37134

Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma, Verona

40000

Khon Kaen University, Khon Kaen

40225

Universitaetsklinikum Duesseldorf, Düsseldorf

40402

China Medical University and Hospital, Taichung

40705

Taichung Veterans General Hospital, Taichung

42090

Necmettin Erbakan University Meram Medical Faculty, Konya

42123

IRCCS Arcispedale Santa Maria Nuova, Reggio Emilia

43201

The Ohio State University, Columbus

44195

Cleveland Clinic - Main Campus, Cleveland

44281

Meir Medical Center, Kfar Saba

44649

Rheumazentrum Ruhrgebiet, Herne

45110

University of Ioannina Medical School, Ioannina

46026

Hospital Universitario y Politecnico La Fe, Valencia

48324

St. Josef-Stift Sendenhorst, Sendenhorst

48824

Michigan State University - Neurology, East Lansing

49100

Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital), Petah Tikva

50139

Azienda Ospedaliero Universitaria Careggi, Florence

50161

Hospital of Lithuanian University of Health Sciences Kauno klinikos, Kaunas

50200

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai

52621

Sheba Medical Center - Rheumatology, Ramat Gan

55121

St. Paul Rheumatology, PA, Saint Paul

56126

A.O. Universitaria Pisana, Pisa

60611

Northwestern Memorial Hospital, Chicago

63110

Washington University School of Medicine, St Louis

66160

University Of Kansas Medical Center, Kansas City

67098

Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes, Strasbourg

68167

Universitatsmedizin Mannheim, Mannheim

69003

Hopital Edouard Herriot, Lyon

70124

Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari - Rheumatology, Bari

72076

Universitaetsklinikum Tuebingen (UKT), Tübingen

73120

Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology, Oklahoma City

75013

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

76031

Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen, Rouen

77030

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

Nerve And Muscle Center Of Texas, Houston

78759

Austin Neuromuscular Center, Austin

80230

Denver Arthritis Clinic, Denver

80336

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

85028

Neuromuscular Research Center, Phoenix

85251

HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology, Scottsdale

89081

Universitatsklinikum Ulm - Standort Oberer Eselsberg, Ulm

90033

University of Southern California Norris Comprehensive Cancer Center, Los Angeles

90039

Attune Health Research, Inc, Beverly Hills

92056

Profound Research LLC - Oceanside, Oceanside

92112

Narodny ustav reumatickych chorob, Piešťany

92270

Eisenhower Medical Center, Rancho Mirage

92868

University of California, Irvine, Orange

94109

California Pacific Medical Center - Sutter Health, San Francisco

97000

Centro Peninsular De Investigacion Clinica, Mérida

97239

Oregon Health and Science University, Portland

98195

University of Washington Medical Center, Seattle

100034

Peking University First Hospital, Beijing

100191

Peking University Third Hospital, Beijing

100730

Peking Union Medical College Hospital, Beijing

110001

China Medical University (CMU) - First Affiliated Hospital, Shenyang

130021

The First Hospital of Jilin University, Changchun

200000

Huashan Hospital Affiliated to Fudan University, Shanghai

200025

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

200127

Shanghai Renji Hospital, Shanghai

210008

Nanjing Drum Tower Hospital, Nanjing

230001

Anhui Provincial Hospital, Hefei

310003

The First Affiliated Hospital - School of Medicine - ZheJiang University, Hangzhou

330000

The Second Affiliated Hospital Of Nanchang University, Nanchang

410008

Xiangya Hospital Central South University, Changsha

410011

The Second Xiangya Hospital of Central South University, Changsha

430030

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

450052

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

451086

Hospital Universitario 12 de Octubre, Madrid

510000

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

510515

Nanfang Hospital, Southern Medical University, Guangzhou

610072

Sichuan Provincial Peoples Hospital, Chengdu

3109601

Rambam Health Care Campus, Haifa

94063-3132

Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine, Redwood City

94143-2202

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

06520

Yale Cancer Center-Yale University School Of Medicine, New Haven

32610-3008

UF Health Rheumatology, Gainesville

02115-6110

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

27514-4220

University of North Carolina (UNC) School of Medicine, Chapel Hill

37232-0028

Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic, Nashville

05401

University of Vermont Medical Center - Main Campus, Burlington

B1902COS

Framingham Centro Medico, La Plata

B1704ETD

Dim Clinica Privada, Ramos Mejía

B1663GKT

Centro Dermatologico Schejtman, San Miguel

T4000AXL

Centro de Investigaciones Medicas Tucuman, San Miguel de Tucumán

H4A 3T2

Genge Partners, Montreal

K1Y 4E9

Ottawa Hospital Research Institute-Civic Campus, Ottawa

128 00

Revmatologicky ustav, Prague

0102

American Hospital Network, Tbilisi

0114

LTD New Hospitals, Tbilisi

0160

Aversi Clinic, Tbilisi

0179

LLC MediClub Georgia, Tbilisi

0180

The First Medical Center, Tbilisi

0186

LTD Tbilisi Heart Center, Tbilisi

115 27

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

115 28

National and Kapodistrian University of Athens - Eginition Hospital, Athens

151 25

Athens Medical Center, Athens

D04 T6F4

St. Vincents University Hospital, Dublin

D15 X40D

Connolly Hospital Blanchardstown, Dublin

F91 X012

North West Rheumatology Unit - Our Lady's Hospital, Manorhamilton

00168

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

00189

Azienda Ospedaliero Universitaria Sant'Andrea, Roma

113-8519

Tokyo Medical And Dental University Hospital, Faculty of Medicine, Bunkyō City

113-8603

Nippon Medical School - Nippon Medical School Hospital, Bunkyō City

216-8511

St. Marianna University School of Medicine Hospital, Kawasaki

830-0011

Kurume University Hospital, Kurume

270-2251

Chiba-Nishi General Hospital, Matsudo-shi

457-8510

Japan Community Healthcare Organization Chukyo Hospital, Nagoya

252-0375

Kitasato University Hospital (KUH), Sagamihara-shi

060-8604

Sapporo City Hospital, Sapporo

060-8648

Hokkaido University Hospital - Rheumatology, Sapporo

857-1165

Sasebo Chuo Hospital, Sasebo-shi

980-8574

Tohoku University Hospital, Sendai

770-8503

Tokushima University Hospital, Tokushima

113-8431

Juntendo University Hospital - Rheumatology, Tokyo

113-8655

The University of Tokyo Hospital, Tokyo

160-8582

Keio University Hospital, Tokyo

305-8576

University of Tsukuba Hospital - Rheumatology, Tsukuba

755-8505

Yamaguchi University Hospital, Ube-shi

641-8509

Wakayama Medical University Hospital - Dermatology, Wakayama

08661

Vilnius University Hospital Santaros Klinikos, Vilnius

06700

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

1105 AZ

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

3584 CX

Universitair Medisch Centrum Utrecht (UMC Utrecht), Utrecht

85-168

Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy, Bydgoszcz

90-549

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

71-252

Centrum Wsparcia Badan Klinicznych Pomorski Uniwersytet Medyczny w Szczecinie, Szczecin

1649-035

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

4099-001

Centro Hospitalar Universitario de Santo Antonio, Porto

02447

Kyung Hee University Medical Center, Seoul

03080

Seoul National University Hospital, Seoul

04763

Hanyang University Seoul Hospital, Seoul

03010

Hospital General Universitario de Alicante, Alicante

08036

Hospital Clinic de Barcelona - Sede Villarroel - Rheumatology, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

9-41014

Hospital De Valme, Seville

06230

Ankara University Medical Faculty, Ankara

06800

Ankara City Hospital, Ankara

BA1 3NG

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

DN2 5LT

Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust, Doncaster

LS7 4SA

Leeds Institute of Rheumatic & Musculoskeletal Medicine - University of Leeds, Leeds

L9 7AL

Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust, Liverpool

NW3 2QG

The Royal Free Hospital - Royal Free London NHS Foundation Trust, London

SE5 9RS

Kings College Hospital NHS Foundation Trust, London

WC1N 3BG

The National Hospital for Neurology and Neurosurgery, London

TS4 3BW

James Cook University Hospital - South Tees Hospitals NHS Foundation Trust, Middlesbrough

M6 8HD

Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford

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