Phase
Condition
Myasthenia Gravis Generalised
Sarcopenia
Polymyositis (Inflammatory Muscle Disease)
Treatment
Cemdisiran
Pozelimab + Cemdisiran
Pozelimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Male or female patients ≥18 years of age at screening (or ≥ legal age of adulthoodbased on local regulations, whichever is older)
Patient with documented diagnosis of myasthenia gravis (MG) based on medical historyand supported by previous evaluations as described in the protocol
Documented prior history of positive serologic test or a positive result duringscreening of anti-acetylcholine receptor (AChR) antibodies or anti-LRP4 antibodies.
Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II toIVa at screening
Myasthenia Gravis-Activities of Daily Living (MG-ADL) score ≥6 at screening. Ocularitems should not contribute more than 50% of MG-ADL total score as described in theprotocol
Currently receiving an acetylcholinesterase inhibitor or documented reason for notusing acetylcholinesterase inhibitor therapy per investigator
Currently receiving an immunosuppressive therapy (IST) for MG, or documented reasonwhy the patient is not taking an IST per investigator
If currently receiving an IST, not anticipated to have IST dosage changed beforerandomization or during double-blind treatment period (DBTP).
Willing and able to comply with clinic visits and study-related procedures,including completion of the primary series of the meningococcal vaccinationsrequired per protocol
Exclusion
Key Exclusion Criteria:
Patients with antibody profile that is only positive for muscle specific tyrosinekinase (MuSK) (MuSK positivity is based on a documented prior history of positiveserologic test for antibodies to MuSK or a positive result during screening
History of thymectomy within 12 months prior to screening or planned during thestudy
History of malignant thymoma (patients with stage 1 may be enrolled), or history ofcancer within the past 5 years, except for adequately treated basal cell skincancer, squamous cell skin cancer, or in situ cervical cancer
Myasthenic crisis or Myasthenia Gravis Foundation of America (MGFA) Class V within 1month of screening
Not meeting meningococcal vaccination requirements and, at a minimum, documentationof quadrivalent meningococcal vaccination within 5 years prior to randomization andserotype B vaccine (when available) within 3 years prior to randomization asdescribed in the protocol
Known contraindication to meningococcal vaccines (group ACWY conjugate and group Bvaccines) as described in the protocol
Patients who require antibiotics for meningococcal prophylaxis and have acontraindication, warning, or precaution precluding the use of penicillin class andpenicillin-alternative antibiotics planned to be used for prophylaxis, or a historyof intolerance leading to the discontinuation of these antibiotics
Positive hepatitis B surface antigen or hepatitis C virus ribonucleic acid (RNA)during screening. NOTE: Cases with unclear interpretation should be discussed withthe medical monitor
History of HIV infection or a positive test at screening per local requirements
NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply
Study Design
Study Description
Connect with a study center
Southern Neurology
Sydney, New South Wales 2217
AustraliaActive - Recruiting
Lyell McEwin Hospital
Elizabeth Vale, South Australia 5112
AustraliaActive - Recruiting
St Vincents Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
St. Vincent's Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
Perron Institute for Neurological and Translational Science
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
Fiona Stanley Hospital
Murdoch, 6150
AustraliaSite Not Available
Universitair Ziekenhuis Antwerpen
Edegem, Antwerp 2650
BelgiumActive - Recruiting
UZ Antwerpen
Edegem, Antwerpen 2650
BelgiumActive - Recruiting
Chu Charleroi
Lodelinsart, Hainaut 6042
BelgiumSite Not Available
AZ Sint-Lucas
Gent, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
Hospital Erasme
Bruxelles, 1070
BelgiumSite Not Available
Université Libre de Bruxelles - Hôpital Erasme
Bruxelles, 1070
BelgiumSite Not Available
IMV Pesquisa Neurologica
Porto Alegre, Rio Grande Do Sul 90110-000
BrazilActive - Recruiting
Jordy Sinapse medicina LTDA
Itapevi, Sao Paulo 06655-250
BrazilActive - Recruiting
Faculdade de Medicina Do ABC
Santo Andre, Sao Paulo 09060-870
BrazilActive - Recruiting
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, 05403-010
BrazilActive - Recruiting
PSEG Centro de Pesquisa Clínica S.A
Sao Paulo, 04038-002
BrazilActive - Recruiting
UNIFESP Universidade Federal de Sao Paulo EPM
Sao Paulo, 04038-031
BrazilActive - Recruiting
University of Alberta
Edmonton, Alberta T6G 2X8
CanadaActive - Recruiting
London Health Sciences Centre
London, Ontario N6A 5A5
CanadaActive - Recruiting
Toronto General Hospital
Toronto, Ontario M5G2C4
CanadaSite Not Available
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec H2X-0J1
CanadaSite Not Available
Centre hospitalier de l'Universite de Montreal
Montreal, Quebec H2X 0C1
CanadaSite Not Available
Peking Union Medical College Hospital
Beijing, Beijing 100032
ChinaActive - Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaActive - Recruiting
Guangdong Hospital of Traditional Chinese Medicine
Guangdong, Guangdong 510120
ChinaActive - Recruiting
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong 510120
ChinaActive - Recruiting
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong 518053
ChinaActive - Recruiting
The University of Hong Kong-Shenzhen Hospital
Shenzhen City, Guangdong 518053
ChinaSite Not Available
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangzhou 510405
ChinaActive - Recruiting
Hainan General Hospital
Haikou City, Hainan 570311
ChinaActive - Recruiting
Renmin Hospital of Wuhan University - Hubei Provincial People's Hospital
Wuhan, Hubei 430060
ChinaActive - Recruiting
Xiangya Hospital Central South University
Changsha, Hunan 410008
ChinaActive - Recruiting
The First Hospital of Jilin University
Changchun, Jilin 130000
ChinaActive - Recruiting
The First Hospital of Jilin University
Changchun City, Jilin 130000
ChinaSite Not Available
Qilu Hospital of Shandong University (Qingdan)
Qingdao, Shandong 266035
ChinaActive - Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai 201107
ChinaActive - Recruiting
The Second Affiliated Hospital of the Chinese Peoples' Liberation Army Air Force Medical University
Xi'an, Shanxi 710032
ChinaActive - Recruiting
The Second Affiliated Hospital of the Chinese Peoples' Liberation Army Air Form Medical University
Xi'an, Shanxi 710032
ChinaActive - Recruiting
The Second Affiliated Hospital of the Chinese Peoples' Liberation Army Air Form Medical University
Xi'an City, Shanxi 710032
ChinaSite Not Available
Sichuan Provincial People's Hospital
Chengdu, Sichuan 610072
ChinaActive - Recruiting
Sichuan Provincial People's Hospital - 2018
Chengdu, Sichuan 610072
ChinaActive - Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin 300050
ChinaActive - Recruiting
Fakultni Nemocnice Brno
Brno, Jihomoravsky Kraj 625 00
CzechiaSite Not Available
Fakultni nemocnice Ostrava
Ostrava, Moravskoslezsky Kraj 708 52
CzechiaSite Not Available
Aalborg Universitetshospital
Aalborg, Nordjylland 09000
DenmarkActive - Recruiting
Aalborg Universitetshospital - Sygehusapoteket
Aalborg, Nordjylland 09000
DenmarkActive - Recruiting
Aarhus University Hospital
Aarhus N, 8200
DenmarkActive - Recruiting
Copenhagen Neuromuscular Clinic at Rigshospitalet
Copenhagen, 3050
DenmarkActive - Recruiting
Rigshospitalet, Copenhagen
Copenhagen, 2100
DenmarkActive - Recruiting
Odense Universitetshospital
Odense, 05000
DenmarkActive - Recruiting
Odense Universitetshospital - Infektionsmedicinsk Afdeling
Odense, 05000
DenmarkActive - Recruiting
Centre Hospitalier Universitaire de Nice
Nice, Alpes Maritimes 6002
FranceActive - Recruiting
Centre Hospitalier Universitaire (CHU) de Nice
Nice, Alpes-Maritimes 6002
FranceActive - Recruiting
CHU Bicetre
Le Kremlin-Bicetre, 94275
FranceActive - Recruiting
CHU Bicêtre
Le Kremlin-Bicêtre, 94275
FranceSite Not Available
Centre Hospitalier Regional Universitaire (CHRU) de Nancy
Nancy, 54035
FranceActive - Recruiting
Hopital de la Pitie Salpetriere
Paris, 75013
FranceActive - Recruiting
Hôpital de la Pitié Salpétrière
Paris, 75013
FranceActive - Recruiting
Centre Hospitalier Regional Universitaire (CHRU) de Nancy
Vandoeuvre Les Nancy, 54511
FranceSite Not Available
Israeli-Georgian Medical Research Clinic HEALTHYCORE
T'bilisi, 0112
GeorgiaSite Not Available
Israeli-Georgian Medical Research Clinic Healthycore, LTD
Tbilisi, 0112
GeorgiaActive - Recruiting
LTD "Israeli-Georgian Medical Research Clinic Healthycore"
Tbilisi, 0112
GeorgiaActive - Recruiting
LTD Academician N. Kipshidze Central University Clinic
Tbilisi, 0160
GeorgiaActive - Recruiting
LTD National Center of Urology Named after L. Managadze
Tbilisi, 0144
GeorgiaActive - Recruiting
LTD New Hospitals
Tbilisi, 0114
GeorgiaActive - Recruiting
Multiprofile Clinic Consilium Medulla
Tbilisi, 0186
GeorgiaActive - Recruiting
Pineo Medical Ecosystem
Tbilisi, 0114
GeorgiaActive - Recruiting
Friedrich Baur Institute Department of Neurology Klinikum Munchen
Munchen, Bayern 80336
GermanyActive - Recruiting
Friedrich-Baur-Institute Dep. of Neurology Klinikum Munchen
Munchen, Bayern 80336
GermanyActive - Recruiting
University Hospital Essen, Dep. of Neurology
Essen, NRW 45127
GermanyActive - Recruiting
Universitatsklinikum Munster
Munster, Nordrhein-Westfalen 48149
GermanyActive - Recruiting
University Hospital Essen
Essen, North Rhine-Westphalia 45127
GermanyActive - Recruiting
Universitatsklinikum Leipzig
Leipzig, Sachsen 04103
GermanyActive - Recruiting
Charite - Universitatsmedizin Berlin
Berlin, 10117
GermanyActive - Recruiting
Universitatsklinikum Jena
Jena, 07747
GermanyActive - Recruiting
Government General Hospital, Guntur
Guntur, Andhra Pradesh 522001
IndiaActive - Recruiting
All India Institute of Medical Sciences New Delhi
New Delhi, Delhi 110029
IndiaActive - Recruiting
Institute Of NeuroSciences
Surat, Gujarat 395001
IndiaSite Not Available
Institute of Neurosciences
Surat, Gujarat 395001
IndiaActive - Recruiting
Nizam's Institute of Medical Sciences (NIMS)
Panjagutta, Hyderabad 500082
IndiaActive - Recruiting
Kasturba Medical College (KMC) - Udupi
Bangalore, Karnataka 576104
IndiaSite Not Available
Kasturba Medical College (KMC)
Manipal, Karnataka 576104
IndiaSite Not Available
Kasturba Medical College (KMC) - Udupi
Manipal, Karnataka 576104
IndiaActive - Recruiting
Kasturba Medical College (KMC)
Udupi, Karnataka 576104
IndiaActive - Recruiting
Amrita Institute of Medical Sciences and Research Centre (AIMS)
Kochi, Kerala 682041
IndiaActive - Recruiting
Jubilee Mission Hospital
Thrissur, Kerala 680005
IndiaSite Not Available
Amrita Institute of Medical Sciences (AIMS) and Research Centre
Kochi, Kerela 682041
IndiaActive - Recruiting
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra 411004
IndiaActive - Recruiting
Seth G.S. Medical College & K.E.M. Hospital, Mumbai
Parel, Mumbai 400012
IndiaActive - Recruiting
Polakulath Narayanan Renai Medicity Multi Specialty Hospital, Kochi
Kochi, Punjab 141008
IndiaActive - Recruiting
Christian Medical College & Hospital
Ludhiana, Punjab 141008
IndiaActive - Recruiting
Department of Neurology, Christian Medical College & Hospital
Ludhiana, Punjab 141008
IndiaSite Not Available
Apex Hospital
Jaipur, Rajasthan 302017
IndiaActive - Recruiting
City Neuro Centre, Hyderabad
Hyderabad, Telangana 500034
IndiaActive - Recruiting
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Lucknow, Uttar Pradesh 226014
IndiaSite Not Available
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) - Department of Neurology
Lucknow, Uttar Pradesh 226014
IndiaSite Not Available
Bangalore Medical College and Research Institute (BMCRI) - Victoria Hospital
Bangalore, 560002
IndiaActive - Recruiting
Postgraduate Institute of Medical Education & Research
Chandigarh, 160012
IndiaActive - Recruiting
Kasturba Medical College (KMC) - Udupi
Karnataka, 576104
IndiaSite Not Available
Azienda Ospedaliera Sant'andrea
Roma, Lazio 00189
ItalyActive - Recruiting
Universita' Degli Studi La Sapienza
Roma, Lazio 00185
ItalyActive - Recruiting
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
Milano, Lombardia 20133
ItalyActive - Recruiting
IRCCS Mondino Foundation
Pavia, Lombardy 27100
ItalySite Not Available
AORN Cardarelli Napoli
Naples, Napoli 80131
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana
Pisa, Toscana 56126
ItalyActive - Recruiting
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127
ItalyActive - Recruiting
Universita' Degli Studi di Roma La Sapienza
Roma, 00161
ItalyActive - Recruiting
Kobe City Medical Center General Hospital
Kobe, Hyogo 650-0047
JapanActive - Recruiting
Kochi Medical School Hospital
Nankoku-shi, Koti 783-8505
JapanActive - Recruiting
Okinawa National Hospital
Ginowan-Shi, Okinawa 901-2214
JapanActive - Recruiting
Okinawa Prefectural Nanbu Medical Center and Children's Medical Center
Shimajiri, Okinawa 901-1193
JapanActive - Recruiting
Okinawa Prefectural Nanbu Medical Center and Children's Medical Center
Shimajiri-Gun, Okinawa 901-1193
JapanSite Not Available
Saitama Medical University, Saitama Medical Center
Kawagoe, Saitama 350-8550
JapanActive - Recruiting
Showa General Hospital
Kodaira, Tokoyo 187-8510
JapanSite Not Available
Medical Hospital of Tokyo Medical and Dental University
Bunkyo-ku, Tokyo 113-8519
JapanActive - Recruiting
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo 173-8610
JapanActive - Recruiting
Tokyo Medical University Hospital
Shinjuku ku, Tokyo 160-0023
JapanActive - Recruiting
Yamaguchi University Hospital
Ube, Yamaguchi 755-8505
JapanActive - Recruiting
Chiba University Hospital
Chiba, 260-8677
JapanActive - Recruiting
Hiroshima City Hiroshima Citiz
Hiroshima, 730-8518
JapanActive - Recruiting
Japanese Red Cross Osaka Hospital
Osaka, 543-8555
JapanActive - Recruiting
Osaka Red Cross Hospital - Neurology
Osaka, 543-8555
JapanActive - Recruiting
Samsung Medical Center - PPDS
Seoul, Seoul Teugbyeolsi 03722
Korea, Republic ofActive - Recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii
Krakow, Malopolskie 31-505
PolandActive - Recruiting
Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii
Kraków, Malopolskie 31-505
PolandSite Not Available
NeuroProtect
Warsaw, Mazovian 01-684
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny
Warszawa, Mosavian 02-097
PolandActive - Recruiting
Gdanski Uniwersytet Medyczny
Gdansk, Pomorskie 80-952
PolandActive - Recruiting
Clinical Research Center Spolka z Ograniczona Odpowiedzialnoscia Medic-R Sp.k
Poznan, Wielkopolskie 61-731
PolandActive - Recruiting
NZOZ Neuro-kard
Poznan, Wielkopolskie 61-853
PolandActive - Recruiting
Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia, Medic-R Spólka Komandytowa
Poznań, Wielkopolskie 61-731
PolandSite Not Available
University Clinical Center of Serbia
Belgrade, 11000
SerbiaActive - Recruiting
University Clinical Center of Serbia - PPDS
Belgrade, 11000
SerbiaActive - Recruiting
University Clinical Centre Nis
Nis, 700461
SerbiaActive - Recruiting
Hospital de La Santa Creu i Sant Pau
Barcelona, 08041
SpainActive - Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital Universitario La Paz - PPDS
Madrid, 28046
SpainTerminated
Hospital Universitari i Politecnic La Fe
Valencia, 46026
SpainActive - Recruiting
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, 833
TaiwanSite Not Available
Chang Gung Memorial Foundation Kaohsiung Branch
Kaohsiung City, 833
TaiwanActive - Recruiting
Chang Gung Memorial Foundation, Kaohsiung Branch
Kaohsiung City, 833
TaiwanActive - Recruiting
China Medical University
Taichung, 40447
TaiwanActive - Recruiting
China Medical University Hospital
Taichung, 40447
TaiwanActive - Recruiting
National Cheng Kung University Hospital
Tainan City, 701
TaiwanActive - Recruiting
Shin Kong Wu Ho Su Memorial Hospital
Taipei, 111
TaiwanActive - Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
TaiwanActive - Recruiting
Chang Gung Memorial Hospital at Linkou
Taoyuan, 333
TaiwanActive - Recruiting
Dokuz Eylul University Medical Faculty
Balcova, Izmir 35340
TurkeySite Not Available
Kocaeli University Hospital
Izmit, Van 41380
TurkeyActive - Recruiting
Kocaeli University Hospital
Umuttepe, Van 41380
TurkeySite Not Available
Dokuz Eylul University Medical Faculty
Izmir, 35340
TurkeyActive - Recruiting
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55239
TurkeyActive - Recruiting
Karadeniz Technical University Farabi Hospital
Trabzon, 61080
TurkeyActive - Recruiting
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, South Yorkshire 511 9NE
United KingdomActive - Recruiting
University Hospital Birmingham
Birmingham, B15 2TH
United KingdomActive - Recruiting
HonorHealth Neurology
Phoenix, Arizona 85018
United StatesSite Not Available
HonorHealth Neurology
Scottsdale, Arizona 85251
United StatesActive - Recruiting
HonorHealth Neurology 2018
Scottsdale, Arizona 85251
United StatesActive - Recruiting
University of California Irvine
Irvine, California 92697
United StatesActive - Recruiting
University of California, Irvine
Irvine, California 92617
United StatesActive - Recruiting
University of Southern California
Los Angeles, California 90033
United StatesActive - Recruiting
University of California, Irvine
Orange, California 92868
United StatesSite Not Available
Colorado Springs Neurological Associates
Colorado Springs, Colorado 80907-5307
United StatesActive - Recruiting
SFM Clinical Research, LLC
Boca Raton, Florida 33487
United StatesActive - Recruiting
Diverse Clinical Research
Miami, Florida 33175
United StatesActive - Recruiting
Aqualane Clinical Research
Naples, Florida 34105
United StatesActive - Recruiting
Collier Neurologic Specialists LLC
Naples, Florida 34105-8523
United StatesActive - Recruiting
Neurological Services of Orlando
Orlando, Florida 32806
United StatesActive - Recruiting
Medsol Clinical Research Center Inc
Port Charlotte, Florida 33952
United StatesActive - Recruiting
University of South Florida
Tampa, Florida 33612
United StatesActive - Recruiting
University of South Florida Morsani Center for Advanced Healthcare
Tampa, Florida 33612
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Northwestern University - Clinical Study Location - Parkinson's Disease and Movement Disorders Center
Chicago, Illinois 60611
United StatesSite Not Available
Northwestern University - Parkinson's Disease and Movement Disorders Center
Chicago, Illinois 60611
United StatesSite Not Available
NorthShore University Health System
Evanston, Illinois 60201-3137
United StatesSite Not Available
NorthShore University Health System
Glenview, Illinois 60026-1301
United StatesActive - Recruiting
Prairie Education and Research Cooperative
O'Fallon, Illinois 62269
United StatesActive - Recruiting
St. Elizabeth's Hospital
O'Fallon, Illinois 62269
United StatesActive - Recruiting
Northwest Neurology Ltd. - Clinedge - PPDS
Rolling Meadows, Illinois 60080
United StatesTerminated
Northwest Neurology Ltd., Clinical Research Dept
Rolling Meadows, Illinois 60080
United StatesTerminated
Wayne State University School of Medicine
Detroit, Michigan 48201
United StatesActive - Recruiting
Weill Cornell Medicine - Peripheral Neuropathy Center
New York, New York 10021
United StatesActive - Recruiting
Atrium Health Neurosciences Institute
Charlotte, North Carolina 28207
United StatesSite Not Available
Atrium Health Neurosciences Institute Charlotte, a facility of Carolinas Medical Center
Charlotte, North Carolina 28207
United StatesSite Not Available
Dayton Center for Neurological Disorders
Centerville, Ohio 45459
United StatesActive - Recruiting
Dayton center for neurological disorders
Centerville, Ohio 45459
United StatesSite Not Available
University Of Cincinnati Gardner Neuroscience institute
Cincinnati, Ohio 45219
United StatesActive - Recruiting
University of Cincinnati Gardner Neuroscience Institute
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Penn Medicine University City
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Texas Institute for Neurological Disorders - Arlington
Arlington, Texas 76015
United StatesSite Not Available
Austin Neuromuscular Center
Austin, Texas 78759
United StatesActive - Recruiting
National Neuromuscular Research Institute
Austin, Texas 78759
United StatesActive - Recruiting
Nerve and Muscle Center of Texas
Houston, Texas 77030
United StatesActive - Recruiting
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