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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

288

Participants

Timeline

Start Date

December 14, 2021

Primary Completion Date

July 18, 2025

Study Completion Date

November 11, 2028

Conditions
Generalized Myasthenia Gravis
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

Trial Locations (116)

111

Shin Kong Wu Ho Su Memorial Hospital, Taipei

333

Chang Gung Memorial Hospital at Linkou, Taoyuan District

701

National Cheng Kung University Hospital, Tainan City

833

Chang Gung Memorial Foundation Kaohsiung Branch, Kaohsiung City

2100

Rigshospitalet, Copenhagen, Copenhagen

2650

Universitair Ziekenhuis Antwerpen, Edegem

6002

Centre Hospitalier Universitaire de Nice, Nice

8200

Aarhus University Hospital, Aarhus N

9000

AZ Sint-Lucas, Ghent

10117

Charite - Universitatsmedizin Berlin, Berlin

19104

Penn Medicine University City, Philadelphia

20133

Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta, Milan

24127

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

32806

Neurological Services of Orlando, Orlando

33175

Diverse Clinical Research, Miami

33487

SFM Clinical Research, LLC, Boca Raton

33612

University of South Florida Morsani Center for Advanced Healthcare, Tampa

33952

Medsol Clinical Research Center Inc, Port Charlotte

34105

Aqualane Clinical Research, Naples

35340

Dokuz Eylul University Medical Faculty, Izmir

40447

China Medical University, Taichung

41380

Kocaeli University Hospital, Izmit

41404

Kyungpook National University Chilgok Hospital, Daegu

45127

University Hospital Essen, Essen

45219

University of Cincinnati Gardner Neuroscience Institute, Cincinnati

45459

Dayton Center for Neurological Disorders, Centerville

46026

Hospital Universitari i Politecnic La Fe, Valencia

48149

Universitatsklinikum Munster, Münster

48201

Wayne State University School of Medicine, Detroit

54035

Centre Hospitalier Regional Universitaire (CHRU) de Nancy, Nancy

55239

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi, Samsun

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

60080

Northwest Neurology Ltd. - Clinedge - PPDS, Rolling Meadows

61080

Karadeniz Technical University Farabi Hospital, Trabzon

62269

St. Elizabeth's Hospital, O'Fallon

75013

Hopital de la Pitie Salpetriere, Paris

77030

Nerve and Muscle Center of Texas, Houston

78759

National Neuromuscular Research Institute, Austin

80336

Friedrich Baur Institute, München

85251

HonorHealth Neurology 2018, Scottsdale

90033

University of Southern California, Los Angeles

92697

University of California Irvine, Irvine

94275

CHU Bicetre, Le Kremlin-Bicêtre

100032

Peking Union Medical College Hospital, Beijing

110029

All India Institute of Medical Sciences New Delhi, New Delhi

130000

The First Hospital of Jilin University, Changchun

141008

Polakulath Narayanan Renai Medicity Multi Specialty Hospital, Kochi, Kochi

Christian Medical College & Hospital, Ludhiana

160012

Postgraduate Institute of Medical Education & Research, Chandigarh

201107

Huashan Hospital Fudan University, Shanghai

266035

Qilu Hospital of Shandong University (Qingdan), Qingdao

300050

Tianjin Medical University General Hospital, Tianjin

302017

Apex Hospital, Jaipur

350001

Fujian Medical University Union Hospital, Fuzhou

395001

Institute of Neurosciences, Surat

400012

Seth G.S. Medical College & K.E.M. Hospital, Mumbai, Pārel

410008

Xiangya Hospital Central South University, Changsha

411004

Deenanath Mangeshkar Hospital and Research Centre, Pune

430060

Renmin Hospital of Wuhan University - Hubei Provincial People's Hospital, Wuhan

500034

City Neuro Centre, Hyderabad, Hyderabad

500082

Nizam's Institute of Medical Sciences (NIMS), Panjagutta

510120

Guangdong Hospital of Traditional Chinese Medicine, Guangdong

Nanfang Hospital Southern Medical University, Guangzhou

510405

The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou

518053

The University of Hong Kong-Shenzhen Hospital, Shenzhen

522001

Government General Hospital, Guntur, Guntur

560002

Bangalore Medical College and Research Institute (BMCRI) - Victoria Hospital, Bangalore

570311

Hainan General Hospital, Haikou

576104

Kasturba Medical College (KMC), Udupi

610072

Sichuan Provincial People's Hospital, Chengdu

682041

Amrita Institute of Medical Sciences and Research Centre (AIMS), Kochi

700461

University Clinical Centre Nis, Niš

710032

The Second Affiliated Hospital of the Chinese Peoples' Liberation Army Air Force Medical University, Xi’an

80907-5307

Colorado Springs Neurological Associates, Colorado Springs

60026-1301

NorthShore University Health System, Glenview

90110-000

IMV Pesquisa Neurologica, Porto Alegre

06655-250

Jordy Sinapse Medicina LTDA, Itapevi

09060-870

Faculdade de Medicina Do ABC, Santo André

04038-002

Pseg Centro de Pesquisa Clinica S.A, São Paulo

05403-010

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo

T6G 2X8

University of Alberta, Edmonton

N6A 5A5

London Health Sciences Centre, London

M5G2C4

Toronto General Hospital, Toronto

09000

Aalborg Universitetshospital, Aalborg

05000

Odense Universitetshospital, Odense

0112

Israeli-Georgian Medical Research Clinic Healthycore, LTD, Tbilisi

0114

LTD New Hospitals, Tbilisi

Pineo Medical Ecosystem, Tbilisi

0144

LTD National Center of Urology Named after L. Managadze, Tbilisi

0186

Multiprofile Clinic Consilium Medulla, Tbilisi

04103

Universitatsklinikum Leipzig, Leipzig

07747

Universitatsklinikum Jena, Jena

00189

Azienda Ospedaliera Sant'andrea, Rome

00161

Universita' Degli Studi di Roma La Sapienza, Roma

650-0047

Kobe City Medical Center General Hospital, Kobe

783-8505

Kochi Medical School Hospital, Nankoku

901-2214

Okinawa National Hospital, Ginowan-Shi

901-1193

Okinawa Prefectural Nanbu Medical Center and Children's Medical Center, Shimajiri

350-8550

Saitama Medical University, Saitama Medical Center, Kawagoe

113-8519

Medical Hospital of Tokyo Medical and Dental University, Bunkyo

160-0023

Tokyo Medical University Hospital, Shinjuku

173-8610

Nihon University Itabashi Hospital, tabashi City

755-8505

Yamaguchi University Hospital, Ube

260-8677

Chiba University Hospital, Chiba

730-8518

Hiroshima City Hiroshima Citiz, Hiroshima

543-8555

Japanese Red Cross Osaka Hospital, Osaka

61-731

Clinical Research Center Spolka z Ograniczona Odpowiedzialnoscia Medic-R Sp.k, Poznan

61-853

NZOZ Neuro-kard, Poznan

31-505

Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii, Krakow

01-684

NeuroProtect, Warsaw

02-097

Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny, Warsaw

80-952

Gdanski Uniwersytet Medyczny, Gdansk

06351

Samsung Medical Center, Seoul

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

511 9NE

Sheffield Teaching Hospital NHS Foundation Trust, Sheffield

B15 2TH

University Hospital Birmingham, Birmingham

All Listed Sponsors
lead

Regeneron Pharmaceuticals

INDUSTRY