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ACTIVE NOT RECRUITING
NCT06298552
PHASE3

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

Sponsor: argenx

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to measure the efficacy and safety of efgartigimod IV compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). The study consists of a Part A where participants will be randomized to receive either efgartigimod IV or placebo IV and a Part B where participants completing part A will receive open-label efgartigimod IV. Participants will be in the study for up to (approximately) 2.5 years.

Official title: A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod IV in Adult Participants With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

119

Start Date

2024-04-16

Completion Date

2027-06

Last Updated

2025-11-05

Healthy Volunteers

No

Interventions

BIOLOGICAL

Efgartigimod IV

Intravenous infusion of efgartigimod

OTHER

Placebo IV

Intravenous infusion of placebo

Locations (91)

HonorHealth Neurology - Bob Bove Neuroscience Institute

Scottsdale, Arizona, United States

Loma Linda University Health

Fresno, California, United States

First Choice Neurology Boca Raton

Boca Raton, Florida, United States

SFM Clinical Research LLC

Boca Raton, Florida, United States

The Neurology Institute / Healthcare Innovations Institute - Coral Springs

Coral Springs, Florida, United States

Neurology Associates PA

Maitland, Florida, United States

Desai Sethi Medical Center

Miami, Florida, United States

Medsol Clinical Research Center Inc

Port Charlotte, Florida, United States

BayCare - St. Anthony's Hospital

St. Petersburg, Florida, United States

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

Tampa, Florida, United States

Wellstar - Augusta University Medical Center

Augusta, Georgia, United States

Kansas University Medical Center - Kansas City

Fairway, Kansas, United States

Rutgers-Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

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

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Erlanger Neuroscience Institute

Chattanooga, Tennessee, United States

National Neuromuscular Research Institute

Austin, Texas, United States

University of Washington Medical Center - Montlake

Seattle, Washington, United States

Hôpital Erasme

Anderlecht, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

AZ Sint-Lucas Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Heritage Medical Research Clinic

Calgary, Canada

Genge Partners Inc.

Montreal, Canada

Ottawa Hospital - Civic Campus

Ottawa, Canada

Xuanwu Hospital Capital Medical University

Beijing, China

The First Hospital of Jilin University

Changchun, China

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

Chongqing, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Fujian Medical University Union Hospital

Fuzhou, China

The First Affiliated Hospital of Guangxi Medical University

Guangxi, China

The First Affiliated Hospital of Guangzhou University Chinese Medicine

Guangzhou, China

Guangdong Province Traditional Chinese Medical Hospital

Guangzhou, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, China

Ningbo Medical Center Lihuili Hospital

Ningbo, China

Qilu Hospital of Shandong University

Qingdao, China

Huashan Hospital Fudan University

Shanghai, China

First Hospital of Shanxi Medical University

Taiyuan, China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Cyprus Institute of Neurology and Genetics

Égkomi, Cyprus

Fakultni nemocnice Brno

Brno, Czechia

Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

Pardubice, Czechia

Aarhus Universitetshospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense Universitetshospital

Odense C, Denmark

Turun Yliopistollinen Keskussairaala

Turku, Finland

AP-HM- Hôpital de La Timone

Marseille, France

CHU de Nice-Hôpital Pasteur

Nice, France

AP-HP - Hôpital de la Pitié Salpétrière

Paris, France

West Georgia Medical Center

Kutaisi, Georgia

Petre Sarajishvili Institute of Neurology

Tbilisi, Georgia

Pineo Medical Ecosystem

Tbilisi, Georgia

New Hospitals

Tbilisi, Georgia

LLC Caucasus Medical Centre

Tbilisi, Georgia

Charité - Universitätsmedizin Berlin

Berlin, Germany

Katholisches Klinikum Bochum - St. Josef Hospital

Bochum, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

Eginitio Hospital

Athens, Greece

University General Hospital ''ATTIKON''

Chaïdári, Greece

University General Hospital of Patras

Pátrai, Greece

AHEPA University General Hospital of Thessaloniki

Thessaloniki, Greece

Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete

Budapest, Hungary

Leiden University Medical Center

Leiden, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Haukeland Universitetssykehus

Bergen, Norway

Oslo Universitetssykehus HF, Ullevål

Oslo, Norway

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, Poland

Centrum Medyczne Neurologia Slaska

Katowice, Poland

Szpital Uniwersytecki w Krakowie

Krakow, Poland

Krakowska Akademia Neurologii Sp. z o.o.

Krakow, Poland

CLINIREM Sp z o.o.

Lublin, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, Poland

ULS de Santa Maria, EPE - Hospital de Santa Maria

Lisbon, Portugal

ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz

Lisbon, Portugal

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

Porto, Portugal

Cluj County Emergency Clinical Hospital

Cluj-Napoca, Romania

Sibiu Emergency County Clinical Hospital

Sibiu, Romania

King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia

National Guard Riyadh

Riyadh, Saudi Arabia

Opsta bolnica MSB - Medicinski Sistemi Beograd

Belgrade, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

Hospital General Universitario Dr. Balmis

Alicante, Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain

Hospital de La Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari Arnau de Vilanova

Lleida, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Clinico Universitario de Santiago

Santiago de Compostela, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

Panthera Biopartners

Glasgow, United Kingdom

Leeds General Infirmary

Leeds, United Kingdom