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A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis
Sponsor: Regeneron Pharmaceuticals
Summary
This study is researching the experimental drugs called pozelimab and cemdisiran, and cemdisiran monotherapy. The study is focused on patients with generalized Myasthenia Gravis (gMG). Myasthenia gravis is a disease that causes weakness and fatigue in muscles in the body because the nerves and muscles are not communicating properly. The aim of the study is to see how effective pozelimab and cemdisiran are when used in combination and when pozelimab and cemdisiran are used alone for patients with gMG. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How the study drugs work inside the body * How much of the study drugs are in the blood at different times * Whether the body makes antibodies against pozelimab and cemdisiran (which could make the drugs less effective or could lead to side effects)
Official title: Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Monotherapy in Patients With Symptomatic Generalized Myasthenia Gravis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
288
Start Date
2021-12-14
Completion Date
2028-11-11
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
Pozelimab + Cemdisiran
Subcutaneous administration as described in the protocol
Cemdisiran
SC administration as described in the protocol
Placebo
SC administration as described in the protocol
Pozelimab
SC administration as described in the protocol
Locations (116)
HonorHealth Neurology 2018
Scottsdale, Arizona, United States
University of California Irvine
Irvine, California, United States
University of Southern California
Los Angeles, California, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
SFM Clinical Research, LLC
Boca Raton, Florida, United States
Diverse Clinical Research
Miami, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
Neurological Services of Orlando
Orlando, Florida, United States
Medsol Clinical Research Center Inc
Port Charlotte, Florida, United States
University of South Florida Morsani Center for Advanced Healthcare
Tampa, Florida, United States
NorthShore University Health System
Glenview, Illinois, United States
St. Elizabeth's Hospital
O'Fallon, Illinois, United States
Northwest Neurology Ltd. - Clinedge - PPDS
Rolling Meadows, Illinois, United States
Wayne State University School of Medicine
Detroit, Michigan, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, United States
University of Cincinnati Gardner Neuroscience Institute
Cincinnati, Ohio, United States
Penn Medicine University City
Philadelphia, Pennsylvania, United States
National Neuromuscular Research Institute
Austin, Texas, United States
Nerve and Muscle Center of Texas
Houston, Texas, United States
Universitair Ziekenhuis Antwerpen
Edegem, Antwerp, Belgium
AZ Sint-Lucas
Ghent, Oost-Vlaanderen, Belgium
IMV Pesquisa Neurologica
Porto Alegre, Rio Grande do Sul, Brazil
Jordy Sinapse Medicina LTDA
Itapevi, São Paulo, Brazil
Faculdade de Medicina Do ABC
Santo André, São Paulo, Brazil
Pseg Centro de Pesquisa Clinica S.A
São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, Brazil
University of Alberta
Edmonton, Alberta, Canada
London Health Sciences Centre
London, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangdong Hospital of Traditional Chinese Medicine
Guangdong, Guangdong, China
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangzhou, China
Hainan General Hospital
Haikou, Hainan, China
Renmin Hospital of Wuhan University - Hubei Provincial People's Hospital
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The First Hospital of Jilin University
Changchun, Jilin, China
Qilu Hospital of Shandong University (Qingdan)
Qingdao, Shandong, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of the Chinese Peoples' Liberation Army Air Force Medical University
Xi’an, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Aalborg Universitetshospital
Aalborg, North Denmark, Denmark
Aarhus University Hospital
Aarhus N, Denmark
Rigshospitalet, Copenhagen
Copenhagen, Denmark
Odense Universitetshospital
Odense, Denmark
Centre Hospitalier Universitaire de Nice
Nice, Alpes Maritimes, France
CHU Bicetre
Le Kremlin-Bicêtre, France
Centre Hospitalier Regional Universitaire (CHRU) de Nancy
Nancy, France
Hopital de la Pitie Salpetriere
Paris, France
Israeli-Georgian Medical Research Clinic Healthycore, LTD
Tbilisi, Georgia
LTD New Hospitals
Tbilisi, Georgia
Pineo Medical Ecosystem
Tbilisi, Georgia
LTD National Center of Urology Named after L. Managadze
Tbilisi, Georgia
Multiprofile Clinic Consilium Medulla
Tbilisi, Georgia
Friedrich Baur Institute
München, Bavaria, Germany
University Hospital Essen
Essen, North Rhine-Westphalia, Germany
Universitatsklinikum Munster
Münster, North Rhine-Westphalia, Germany
Universitatsklinikum Leipzig
Leipzig, Saxony, Germany
Charite - Universitatsmedizin Berlin
Berlin, Germany
Universitatsklinikum Jena
Jena, Germany
Government General Hospital, Guntur
Guntur, Andhra Pradesh, India
Institute of Neurosciences
Surat, Gujarat, India
Nizam's Institute of Medical Sciences (NIMS)
Panjagutta, Hyderabad, India
Kasturba Medical College (KMC)
Udupi, Karnataka, India
Amrita Institute of Medical Sciences and Research Centre (AIMS)
Kochi, Kerala, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, India
Seth G.S. Medical College & K.E.M. Hospital, Mumbai
Pārel, Mumbai, India
All India Institute of Medical Sciences New Delhi
New Delhi, National Capital Territory of Delhi, India
Polakulath Narayanan Renai Medicity Multi Specialty Hospital, Kochi
Kochi, Punjab, India
Christian Medical College & Hospital
Ludhiana, Punjab, India
Apex Hospital
Jaipur, Rajasthan, India
City Neuro Centre, Hyderabad
Hyderabad, Telangana, India
Bangalore Medical College and Research Institute (BMCRI) - Victoria Hospital
Bangalore, India
Postgraduate Institute of Medical Education & Research
Chandigarh, India
Azienda Ospedaliera Sant'andrea
Rome, Lazio, Italy
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
Universita' Degli Studi di Roma La Sapienza
Roma, Italy
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Kochi Medical School Hospital
Nankoku, Kochi, Japan
Okinawa National Hospital
Ginowan-Shi, Okinawa, Japan
Okinawa Prefectural Nanbu Medical Center and Children's Medical Center
Shimajiri, Okinawa, Japan
Saitama Medical University, Saitama Medical Center
Kawagoe, Saitama, Japan
Medical Hospital of Tokyo Medical and Dental University
Bunkyo, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku, Tokyo, Japan
Nihon University Itabashi Hospital
tabashi City, Tokyo, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Chiba University Hospital
Chiba, Japan
Hiroshima City Hiroshima Citiz
Hiroshima, Japan
Japanese Red Cross Osaka Hospital
Osaka, Japan
Clinical Research Center Spolka z Ograniczona Odpowiedzialnoscia Medic-R Sp.k
Poznan, Greater Poland Voivodeship, Poland
NZOZ Neuro-kard
Poznan, Greater Poland Voivodeship, Poland
Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii
Krakow, Lesser Poland Voivodeship, Poland
NeuroProtect
Warsaw, Mazovian, Poland
Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny
Warsaw, Mosavian, Poland
Gdanski Uniwersytet Medyczny
Gdansk, Pomeranian Voivodeship, Poland
University Clinical Centre Nis
Niš, Serbia
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Chang Gung Memorial Foundation Kaohsiung Branch
Kaohsiung City, Taiwan
China Medical University
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Shin Kong Wu Ho Su Memorial Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital at Linkou
Taoyuan District, Taiwan
Kocaeli University Hospital
Izmit, Van, Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, Turkey (Türkiye)
Karadeniz Technical University Farabi Hospital
Trabzon, Turkey (Türkiye)
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom
University Hospital Birmingham
Birmingham, United Kingdom