A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

119

Participants

Timeline

Start Date

April 16, 2024

Primary Completion Date

July 25, 2025

Study Completion Date

July 23, 2027

Conditions
Generalized Myasthenia Gravis
Interventions
BIOLOGICAL

Efgartigimod IV

Intravenous infusion of efgartigimod

OTHER

Placebo IV

Intravenous infusion of placebo

Trial Locations (91)

424

Oslo Universitetssykehus HF, Ullevål, Oslo

1070

Hôpital Erasme, Anderlecht

1082

Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete, Budapest

1200

Cliniques Universitaires Saint-Luc, Brussels

2100

Rigshospitalet, Copenhagen

2371

Cyprus Institute of Neurology and Genetics, Égkomi

3000

UZ Leuven, Leuven

4600

West Georgia Medical Center, Kutaisi

5000

Odense Universitetshospital, Odense C

5021

Haukeland Universitetssykehus, Bergen

8035

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

8041

Hospital de La Santa Creu i Sant Pau, Barcelona

8200

Aarhus Universitetshospital, Aarhus

9000

AZ Sint-Lucas Gent, Ghent

11000

Opsta bolnica MSB - Medicinski Sistemi Beograd, Belgrade

11211

King Faisal Specialist Hospital & Research Center, Riyadh

13353

Charité - Universitätsmedizin Berlin, Berlin

13386

AP-HM- Hôpital de La Timone, Marseille

14611

National Guard Riyadh, Riyadh

15706

Hospital Clinico Universitario de Santiago, Santiago de Compostela

20540

Turun Yliopistollinen Keskussairaala, Turku

25198

Hospital Universitari Arnau de Vilanova, Lleida

27710

Duke University School of Medicine - Duke Early Phase Clinical Research Unit, Durham

28304

Hospital Universitario Ramon y Cajal, Madrid

30912

Wellstar - Augusta University Medical Center, Augusta

32751

Neurology Associates PA, Maitland

33067

The Neurology Institute / Healthcare Innovations Institute - Coral Springs, Coral Springs

33136

Desai Sethi Medical Center, Miami

33428

First Choice Neurology Boca Raton, Boca Raton

33487

SFM Clinical Research LLC, Boca Raton

33612

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

33952

Medsol Clinical Research Center Inc, Port Charlotte

34000

University Clinical Center Kragujevac, Kragujevac

44195

Cleveland Clinic, Cleveland

44791

Katholisches Klinikum Bochum - St. Josef Hospital, Bochum

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

66205

Kansas University Medical Center - Kansas City, Fairway

75013

AP-HP - Hôpital de la Pitié Salpétrière, Paris

78756

National Neuromuscular Research Institute, Austin

85251

HonorHealth Neurology - Bob Bove Neuroscience Institute, Scottsdale

97080

Universitätsklinikum Würzburg, Würzburg

98195

University of Washington Medical Center - Montlake, Seattle

100053

Xuanwu Hospital Capital Medical University, Beijing

130021

The First Hospital of Jilin University, Changchun

200040

Huashan Hospital Fudan University, Shanghai

266035

Qilu Hospital of Shandong University, Qingdao

315041

Ningbo Medical Center Lihuili Hospital, Ningbo

350001

Fujian Medical University Union Hospital, Fuzhou

400012

Cluj County Emergency Clinical Hospital, Cluj-Napoca

400016

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chongqing

The First Affiliated Hospital of Chongqing Medical University, Chongqing

430030

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

510405

The First Affiliated Hospital of Guangzhou University Chinese Medicine, Guangzhou

518053

Guangdong Province Traditional Chinese Medical Hospital, Guangzhou

530021

The First Affiliated Hospital of Guangxi Medical University, Guangxi

550004

The Affiliated Hospital of Guizhou Medical University, Guiyang

550166

Sibiu Emergency County Clinical Hospital, Sibiu

93701-2234

Loma Linda University Health, Fresno

33705-1410

BayCare - St. Anthony's Hospital, St. Petersburg

08901-1962

Rutgers-Robert Wood Johnson Medical School, New Brunswick

27599-7025

University of North Carolina - Chapel Hill, Chapel Hill

37403-2173

Erlanger Neuroscience Institute, Chattanooga

T2N 4Z6

Heritage Medical Research Clinic, Calgary

H4A 3T2

Genge Partners Inc., Montreal

K1H 8L6

Ottawa Hospital - Civic Campus, Ottawa

030001

First Hospital of Shanxi Medical University, Taiyuan

625 00

Fakultni nemocnice Brno, Brno

530 03

Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Pardubice

06000

CHU de Nice-Hôpital Pasteur, Nice

0112

Petre Sarajishvili Institute of Neurology, Tbilisi

Pineo Medical Ecosystem, Tbilisi

0114

New Hospitals, Tbilisi

0186

LLC Caucasus Medical Centre, Tbilisi

115 28

Eginitio Hospital, Athens

124 62

University General Hospital ''ATTIKON'', Chaïdári

265 04

University General Hospital of Patras, Pátrai

546 36

AHEPA University General Hospital of Thessaloniki, Thessaloniki

2333 ZA

Leiden University Medical Center, Leiden

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

85-065

MICS Centrum Medyczne Bydgoszcz, Bydgoszcz

40-689

Centrum Medyczne Neurologia Slaska, Katowice

31-503

Szpital Uniwersytecki w Krakowie, Krakow

31-505

Krakowska Akademia Neurologii Sp. z o.o., Krakow

20-883

CLINIREM Sp z o.o., Lublin

50-556

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw

1150-199

ULS de Santa Maria, EPE - Hospital de Santa Maria, Lisbon

1349-019

ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz, Lisbon

4050-011

Hospital de Santo António - Unidade Local de Saúde de Santo António, Porto

03010

Hospital General Universitario Dr. Balmis, Alicante

G51 4TY

Panthera Biopartners, Glasgow

LS1 3EX

Leeds General Infirmary, Leeds

Sponsors

Lead Sponsor

All Listed Sponsors
lead

argenx

INDUSTRY