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ACTIVE NOT RECRUITING
NCT05070858
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Pozelimab + Cemdisiran

Subcutaneous administration as described in the protocol

DRUG

Cemdisiran

SC administration as described in the protocol

OTHER

Placebo

SC administration as described in the protocol

DRUG

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