A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
NCT ID: NCT06298552
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
119 participants
INTERVENTIONAL
2024-04-16
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Efgartigimod IV
Patients receiving efgartigimod IV in both part A and part B
Efgartigimod IV
Intravenous infusion of efgartigimod
Placebo
Patients receiving placebo during part A and receiving efgartigimod IV during part B
Efgartigimod IV
Intravenous infusion of efgartigimod
Placebo IV
Intravenous infusion of placebo
Interventions
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Efgartigimod IV
Intravenous infusion of efgartigimod
Placebo IV
Intravenous infusion of placebo
Eligibility Criteria
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Inclusion Criteria
* The participant is capable of providing signed informed consent and following with protocol requirements.
* The participant agrees to use contraceptive measures consistent with local regulations and the women of child-bearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at baseline before receiving the study drug.
* The participant has no known weakness in infancy and later develop fatigable weakness after aged 16 years and diagnosed with acquired gMG of both of the following:
1. History of abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation (RNS) or is anti-muscle-specific kinase antibodies (MuSK-Ab) seropositive
2. Either a history of positive edrophonium chloride test OR a demonstrated improvement in MG signs with treatments such as oral acetylcholinesterase (AChE) inhibitors, plasma exchange (PLEX), immunoabsorption, or intravenous immunoglobulin (IVIg)/ subcutaneous immunoglobulin (SCIg) treatment
* The participant is receiving a stable dose of MG therapy before screening that includes acetylcholinesterase (AChE) inhibitors, steroids, or nonsteroidal immunosuppressive therapies (NSISTs) in combination or alone.
Exclusion Criteria
* History of malignancy, cancer, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological findings of prostate cancer
* Clinically significant active infection that is not sufficiently resolved in the investigator's opinion or positive serum test at screening for active infection with any of the following: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV
* History of or current alcohol, drug, or medication abuse as assessed by the investigator
* Pregnant or lactating state or intention to become pregnant during the study
* Live or live-attenuated vaccine received \<4 weeks before screening
* Worsening muscle weakness secondary to concurrent infections or medications
* Received a thymectomy less than 3 months before screening or thymectomy is planned during the study
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Related Links
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US patient website
US HCP website
Other Identifiers
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2024-511796-15-00
Identifier Type: OTHER
Identifier Source: secondary_id
ARGX-113-2308
Identifier Type: -
Identifier Source: org_study_id
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