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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
180
Start Date
2024-07-17
Completion Date
2029-01
Last Updated
2026-03-10
Healthy Volunteers
No
Conditions
Interventions
Telitacicept
Subcutaneous injection
Placebo
Subcutaneous injection
Locations (84)
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
Allied Biomedical Research Institute (ABRI)
Miami, Florida, United States
Medsol Clinical Research Center
Port Charlotte, Florida, United States
Wellstar MCG Health Medical Center
Augusta, Georgia, 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
Mount Sinai Health System
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Cincinnati Health Physicians - Clifton
Cincinnati, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, 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
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 Hospital - London Health Sciences Centre
London, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
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
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Kyushu University Hospital
Fukuoka, Japan
National Hospital Organization Utano National Hospital
Kyoto, Japan
Niepubliczny Zakład Opieki Zdrowotnej NEURO - KARD
Poznan, Greater Poland Voivodeship, Poland
Medicover Integrated Clinical Services (MICS) - Centrum Medyczne Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Neurocentrum Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Krakowska Akademia Neurologii Sp. z o.o.
Krakow, Lesser Poland Voivodeship, Poland
Clinirem - Lublin
Lublin, Lublin Voivodeship, Poland
Centrum Medyczne Hope Clinic
Lublin, Lubusz Voivodeship, Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól, Lubusz Voivodeship, Poland
Centrum Medyczne Neuroprot
Warsaw, Masovian Voivodeship, Poland
MTZ Powered by Pratia
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, Pomeranian Voivodeship, Poland
Neurologia Śląska Centrum Medyczne
Katowice, Silesian Voivodeship, Poland
Hospital Universitari Mútua Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario de Basurto
Bilbao, Biscay, Spain
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain