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A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)
Sponsor: Vor Biopharma
Summary
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With an Open-label Extension Period to Evaluate the Efficacy and Safety of Telitacicept in Patients With Generalized Myasthenia Gravis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
191
Start Date
2024-07-17
Completion Date
2029-01
Last Updated
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
Telitacicept
Subcutaneous injection
Placebo
Subcutaneous injection
Locations (120)
HonorHealth Neurology - Bob Bové Neuroscience Institute
Scottsdale, Arizona, United States
University of Southern California
Los Angeles, California, United States
University of California Irvine
Orange, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
SFM Clinical Research
Boca Raton, Florida, United States
BayCare Medical Group - Clearwater
Clearwater, Florida, United States
Allied Biomedical Research Institute (ABRI)
Miami, Florida, United States
Medsol Clinical Research Center
Port Charlotte, Florida, United States
University of South Florida Health (USF Health)
Tampa, Florida, United States
Wellstar MCG Health Medical Center
Augusta, Georgia, United States
Hospital Sisters Health System Medical
O'Fallon, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
University of Louisville Physicians
Louisville, Kentucky, United States
Neurology Center of New England
Foxborough, Massachusetts, United States
Michigan State University Clinical Center
East Lansing, Michigan, United States
Trinity Health - Grand Rapids Hospital
Grand Rapids, Michigan, United States
UM Health Care - Neurology and Sleep Disorders Clinic
Columbia, Missouri, United States
Robert Wood Johnson University Hospital New Brunswick
New Brunswick, New Jersey, United States
Lange Neurology
New York, New York, United States
Mount Sinai Health System
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina Hospitals - Neurology Clinic
Chapel Hill, North Carolina, United States
University of Cincinnati Health Physicians - Clifton
Cincinnati, Ohio, United States
Empower Clinical Research
Tigard, Oregon, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Neurology Rare Disease Center
Flower Mound, Texas, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
Center for Neurological Disorders, S.C. - Greenfield - Gamma Therapeutic Center
Greenfield, Wisconsin, United States
STAT Research S.A.
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital General de Agudos José María Ramos Mejía
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
INECO Neurociencias Oroño
Rosario, Santa Fe Province, Argentina
Fundación Scherbovsky
Mendoza, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Townsville University Hospital
Douglas, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg
Leuven, Flemish Brabant, Belgium
Centre Hospitalier Régional de la Citadelle
Liège, Belgium
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Universidade Estadual de Campinas
Campinas, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Pseg Centro de Pesquisa Clinica
São Paulo, Brazil
University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov
Sevlievo, Gabrovo, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment
Panagyurishte, Pazardzhik, Bulgaria
Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum
Sofia, Sofia-Grad, Bulgaria
University Multiprofile Hospital for Active Treatment Aleksandrovska
Sofia, Sofia-Grad, Bulgaria
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Pleven, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti George - Base 2
Plovdiv, Bulgaria
University Hospital - London Health Sciences Centre
London, Ontario, Canada
AnHui Provincial Hospital
Hefei, Anhui, China
Beijing Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The Second Hospital & Clinical Medical School. Lan Zhou University
Lanzhou, Gansu, China
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Affiliated Hospital of ZunYi Medical University
Zunyi, Guizhou, China
TongJi Medical College of HUST
Wuhan, Hubei, China
XiangYa Hospital of Central South University
Changsha, Hunan, China
Jilin University China-Japan Union Hospital
Changchun, Jilin, China
The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi'an, Shaanxi, China
Xi'An GaoXin Hospital
Xi'an, Shaanxi, China
QiLU Hospital of ShanDong University
Jinan, Shangdong, China
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Jinan, Shangdong, China
The First People's Hospital of JiNing Medical University
Jining, Shangdong, China
Huashan Hospital of the ShangHai FuDan University Medical College
Shanghai, Shanghai Municipality, China
First Hospital of ShanXi Medical University
Taiyuan, Shanxi, China
NingBo Medical Center LiHuiLi Hospital
Ningbo, Zhejiang, China
The 1 School of Medicine, School of Information and Engineering. The 1 Affiliated Hospital of WMU.
Wenzhou, Zhejiang, China
Fakultni Nemocnice Ostrava
Ostrava-Poruba, Moravian-Silesian, Czechia
MINKSneuro s.r.o. - MUDr. Eduard Minks Ph.D.
Brno, South Moravian, Czechia
Fakultni Nemocnice Brno
Brno, South Moravian, Czechia
Hôpital Pasteur
Nice, Alpes-Maritimes, France
Groupe Hospitalier Pellegrin
Bordeaux, Gironde, France
Multi-profile Clinic "New Hospitals"
Tbilisi, Georgia
Pineo Medical Ecosystem
Tbilisi, Georgia
Aversi Clinic - Central Branch
Tbilisi, Georgia
Simon Khechinashvili University Hospital
Tbilisi, Georgia
IRCCS Fondazione Casa Sollievo della Sofferenza SG Rotondo
San Giovanni Rotondo, Foggia, Italy
Fondazione Istituto San Raffaele - G. Giglio Di Cefalu
Cefalù, Palermo, Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
Naples, Italy
Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli
Naples, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Istituto Neurologico Casimiro Mondino
Pavia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Azienda Ospedaliera - Universitaria Sant' Andrea
Rome, Italy
National Hospital Organization - Nagoya Medical Center
Nagoya, Aichi-ken, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa, Japan
Yokohama Medical Center
Yokohama, Kanagawa, Japan
NHO Sendai Medical Center
Sendai, Miyagi, Japan
National Hospital Organization Niigata National Hospital
Kashiwazaki-Shi, Niigata, Japan
Okinawa National Hospital
Ginowan-Shi, Okinawa, Japan
Nagoya City University Hospital
Suita-shi, Osaka, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Sizuoka [Shizuoka], Japan
Tokushima University Hospital
Tokushima, Tokusima [Tokushima], Japan