Phase
Condition
Polymyositis (Inflammatory Muscle Disease)
Neuropathy
Sarcopenia
Treatment
Efgartigimod IV
Placebo IV
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The participant is at least 18 years of age and the local legal age of consent forclinical studies when signing the ICF.
The participant is capable of providing signed informed consent and following withprotocol requirements.
The participant agrees to use contraceptive measures consistent with localregulations and the women of child-bearing potential (WOCBP) must have a negativeserum pregnancy test result at screening and a negative urine pregnancy test resultat baseline before receiving the study drug.
The participant has no known weakness in infancy and later develop fatigableweakness after aged 16 years and diagnosed with acquired gMG of both of thefollowing:
History of abnormal neuromuscular transmission demonstrated by single fiberelectromyography or repetitive nerve stimulation (RNS) or isanti-muscle-specific kinase antibodies (MuSK-Ab) seropositive
Either a history of positive edrophonium chloride test OR a demonstratedimprovement in MG signs with treatments such as oral acetylcholinesterase (AChE) inhibitors, plasma exchange (PLEX), immunoabsorption, or intravenousimmunoglobulin (IVIg)/ subcutaneous immunoglobulin (SCIg) treatment
- The participant is receiving a stable dose of MG therapy before screening thatincludes acetylcholinesterase (AChE) inhibitors, steroids, or nonsteroidalimmunosuppressive therapies (NSISTs) in combination or alone.
Exclusion
Exclusion Criteria:
Known autoimmune disease or any medical condition that would interfere with anaccurate assessment of clinical symptoms of gMG or puts the participant at unduerisk
History of malignancy, cancer, unless considered cured by adequate treatment with noevidence of recurrence for ≥3 years. Adequately treated participants with thefollowing cancers can be included at any time: Basal cell or squamous cell skincancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidentalhistological findings of prostate cancer
Clinically significant active infection that is not sufficiently resolved in theinvestigator's opinion or positive serum test at screening for active infection withany of the following: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV
History of or current alcohol, drug, or medication abuse as assessed by theinvestigator
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 plannedduring the study
The complete list of exclusion criteria can be found in the protocol.
Study Design
Connect with a study center
Hôpital Erasme
Anderlecht, 1070
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc
Brussels, 1200
BelgiumSite Not Available
AZ Sint-Lucas Gent
Gent, 9000
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
Heritage Medical Research Clinic
Calgary, T2N 4Z6
CanadaSite Not Available
Genge Partners Inc.
Montreal, H4A 3T2
CanadaSite Not Available
Ottawa Hospital - Civic Campus
Ottawa, K1H 8L6
CanadaSite Not Available
Xuanwu Hospital Capital Medical University
Beijing, 100053
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, 130021
ChinaSite Not Available
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chongqing, 400016
ChinaSite Not Available
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
ChinaSite Not Available
Fujian Medical University Union Hospital
Fuzhou, 350001
ChinaSite Not Available
The First Affiliated Hospital of Guangxi Medical University
Guangxi, 530021
ChinaSite Not Available
Guangdong Province Traditional Chinese Medical Hospital
Guangzhou, 518053
ChinaSite Not Available
The First Affiliated Hospital of Guangzhou University Chinese Medicine
Guangzhou, 510405
ChinaSite Not Available
The Affiliated Hospital of Guizhou Medical University
Guiyang, 550004
ChinaSite Not Available
Ningbo Medical Center Lihuili Hospital
Ningbo, 315041
ChinaSite Not Available
Qilu Hospital of Shandong University
Qingdao, 266035
ChinaSite Not Available
Huashan Hospital Fudan University
Shanghai, 200040
ChinaSite Not Available
First Hospital of Shanxi Medical University
Taiyuan, 030001
ChinaSite Not Available
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430030
ChinaSite Not Available
Cyprus Institute of Neurology and Genetics
Egkomi, 2371
CyprusSite Not Available
Fakultni nemocnice Brno
Brno, 625 00
Czech RepublicActive - Recruiting
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
Pardubice, 530 03
Czech RepublicActive - Recruiting
Fakultni nemocnice Brno
Brno, 625 00
CzechiaSite Not Available
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
Pardubice, 530 03
CzechiaSite Not Available
Aarhus Universitetshospital
Aarhus, 8200
DenmarkSite Not Available
Rigshospitalet
Copenhagen, 2100
DenmarkSite Not Available
Odense Universitetshospital
Odense C, 5000
DenmarkSite Not Available
Turun Yliopistollinen Keskussairaala
Turku, 20540
FinlandSite Not Available
AP-HM- Hôpital de La Timone
Marseille, 13386
FranceSite Not Available
AP-HM- Hôpital de La Timone
Marseilles, 13386
FranceSite Not Available
CHU de Nice-Hôpital Pasteur
Nice, 06000
FranceSite Not Available
AP-HP - Hôpital de la Pitié Salpétrière
Paris, 75013
FranceSite Not Available
West Georgia Medical Center
Kutaisi, 4600
GeorgiaSite Not Available
LLC Caucasus Medical Centre
Tbilisi, 0186
GeorgiaSite Not Available
New Hospitals
Tbilisi, 0114
GeorgiaSite Not Available
Petre Sarajishvili Institute of Neurology
Tbilisi, 0112
GeorgiaSite Not Available
Pineo Medical Ecosystem
Tbilisi, 0112
GeorgiaSite Not Available
Charité - Universitätsmedizin Berlin
Berlin, 13353
GermanySite Not Available
Katholisches Klinikum Bochum - St. Josef Hospital
Bochum, 44791
GermanySite Not Available
Universitätsklinikum Würzburg
Würzburg, 97080
GermanySite Not Available
Eginitio Hospital
Athens, 115 28
GreeceSite Not Available
University General Hospital ''ATTIKON''
Chaidari, 124 62
GreeceSite Not Available
University General Hospital of Patras
Patra, 265 04
GreeceSite Not Available
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 546 36
GreeceSite Not Available
Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete
Budapest, 1082
HungarySite Not Available
Leiden University Medical Center
Leiden, 2333 ZA
NetherlandsSite Not Available
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
NetherlandsSite Not Available
Haukeland Universitetssykehus
Bergen, 5021
NorwaySite Not Available
Oslo Universitetssykehus HF, Ullevål
Oslo, 424
NorwaySite Not Available
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85-065
PolandSite Not Available
Centrum Medyczne Neurologia Slaska
Katowice, 40-689
PolandSite Not Available
Krakowska Akademia Neurologii Sp. z o.o.
Kraków, 31-505
PolandSite Not Available
Szpital Uniwersytecki w Krakowie
Kraków, 31-503
PolandSite Not Available
CLINIREM Sp z o.o.
Lublin, 20-883
PolandSite Not Available
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wrocław, 50-556
PolandSite Not Available
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisboa, 1349-019
PortugalSite Not Available
ULS de Santa Maria, EPE - Hospital de Santa Maria
Lisboa, 1150-199
PortugalSite Not Available
Hospital de Santo António - Unidade Local de Saúde de Santo António
Porto, 4050-011
PortugalSite Not Available
Cluj County Emergency Clinical Hospital
Cluj Napoca, 400012
RomaniaSite Not Available
Sibiu Emergency County Clinical Hospital
Sibiu, 550166
RomaniaSite Not Available
King Faisal Specialist Hospital & Research Center
Riyadh, 11211
Saudi ArabiaSite Not Available
National Guard Riyadh
Riyadh, 14611
Saudi ArabiaSite Not Available
Opsta bolnica MSB - Medicinski Sistemi Beograd
Belgrade, 11000
SerbiaSite Not Available
University Clinical Center Kragujevac
Kragujevac, 34000
SerbiaSite Not Available
Hospital General Universitario Dr. Balmis
Alicante, 03010
SpainSite Not Available
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8035
SpainSite Not Available
Hospital de La Santa Creu i Sant Pau
Barcelona, 8041
SpainSite Not Available
Hospital Universitari Arnau de Vilanova
Lleida, 25198
SpainSite Not Available
Hospital Universitario Ramon y Cajal
Madrid, 28304
SpainSite Not Available
Hospital Clinico Universitario de Santiago
Santiago de Compostela, 15706
SpainSite Not Available
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
SpainSite Not Available
Panthera Biopartners
Glasgow, G51 4TY
United KingdomSite Not Available
Leeds General Infirmary
Leeds, LS1 3EX
United KingdomSite Not Available
HonorHealth Neurology - Bob Bove Neuroscience Institute
Scottsdale, Arizona 85251
United StatesSite Not Available
Loma Linda University Health
Fresno, California 93701-2234
United StatesSite Not Available
First Choice Neurology Boca Raton
Boca Raton, Florida 33428
United StatesSite Not Available
SFM Clinical Research LLC
Boca Raton, Florida 33487
United StatesSite Not Available
The Neurology Institute / Healthcare Innovations Institute - Coral Springs
Coral Springs, Florida 33067
United StatesSite Not Available
Neurology Associates PA
Maitland, Florida 32751
United StatesSite Not Available
Desai Sethi Medical Center
Miami, Florida 33136
United StatesSite Not Available
University of Miami Miller School of Medicine
Miami, Florida 33136-2137
United StatesSite Not Available
Medsol Clinical Research Center Inc
Port Charlotte, Florida 33952
United StatesSite Not Available
BayCare - St. Anthony's Hospital
Saint Petersburg, Florida 33705-1410
United StatesSite Not Available
University of South Florida (USF) Health - Morsani Center for Advanced Healthcare
Tampa, Florida 33612
United StatesSite Not Available
Wellstar - Augusta University Medical Center
Augusta, Georgia 30912
United StatesSite Not Available
Northwestern Medicine - Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesSite Not Available
Kansas University Medical Center - Kansas City
Fairway, Kansas 66205
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Henry Ford Health - Henry Ford Hospital
Detroit, Michigan 48202
United StatesSite Not Available
Saint Louis University
Saint Louis, Missouri 63106
United StatesSite Not Available
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901-1962
United StatesSite Not Available
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina 27599-7025
United StatesSite Not Available
Carolinas HealthCare System Neurosciences Institute-Neurology
Charlotte, North Carolina 28207-1885
United StatesSite Not Available
Duke University School of Medicine - Duke Early Phase Clinical Research Unit
Durham, North Carolina 27710
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Erlanger Neuroscience Institute
Chattanooga, Tennessee 37403-2173
United StatesSite Not Available
National Neuromuscular Research Institute
Austin, Texas 78756
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23298-5048
United StatesSite Not Available
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.