A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (RemeMG)
NCT ID: NCT06456580
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2024-07-17
2028-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Telitacicept in Generalized Myasthenia Gravis
NCT05737160
Telitacicept and Low-dose Steroids in Refractory Myasthenia Gravis
NCT06723548
A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
NCT03772587
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis
NCT01325571
A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis
NCT06744920
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Telitacicept is a fully human TACI-Fc fusion protein that targets B-lymphocyte stimulator (BLyS) and A proliferating-inducing ligand (APRIL), neutralizing their interactions with receptors on B cells. The blockage of BLyS and APRIL interaction with their respective cell membrane receptors (transmembrane activator and CAML interactor \[TACI\], B-cell maturation antigen, and BLyS receptors) by telitacicept would inhibit B-cell proliferation and maturation. This suppression at the proximal portion of the immune response could alleviate autoimmune symptoms.
This study is a randomized, double-blind, placebo-controlled Phase 3 study with an open-label extension to evaluate the efficacy and safety of telitacicept in a global patient population with gMG.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Telitacicept
Telitacicept
Telitacicept
Subcutaneous injection
Placebo
Placebo
Placebo
Subcutaneous injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Telitacicept
Subcutaneous injection
Placebo
Subcutaneous injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients have prior confirmed diagnosis of gMG with generalized muscle weakness (typical pattern of weakness meeting the clinical criteria for diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) clinical classification II-IV.
3. Patients have positive antibodies against AChR or MuSK at screening.
4. MG-ADL score ≥6 points at screening and baseline with ocular-related score \<50% of the total score.
5. QMG score ≥8 points, and ≥ 4 items score at least 2 points at screening and baseline.
Exclusion Criteria
2. Patients having acute or chronic infection.
3. Patients having thymoma within 5 years or received thymectomy ≤6 months prior to screening.
4. Patients having current or history of primary immunodeficiency.
5. Patients having history of malignancy within the last 5 years.
6. Patient having prior or continuing diagnosis of serious cardiovascular disease.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vor Biopharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Fundación Scherbovsky
Mendoza, Mendoza Province, Argentina
INECO Neurociencias Oroño
Rosario, Santa Fe Province, 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, 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
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
Napoli, Napoli, Italy
Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli
Napoli, Napoli, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Napoli, Italy
Fondazione Istituto San Raffaele - G. Giglio Di Cefalu
Cefalù, Palermo, Italy
Istituto Neurologico Casimiro Mondino
Pavia, Pavia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Rome, Italy
Azienda Ospedaliera - Universitaria Sant' Andrea
Rome, Rome, Italy
National Hospital Organization - Nagoya Medical Center
Nagoya, Aichi-ken, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 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
National Hospital Organization Utano National Hospital
Kyoto, Kyoto, 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
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 General Universitario Dr. Balmis
Alicante, Alicante, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital Universitari Mútua Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario de Basurto
Bilbao, Biscay, Spain
Hospital Universitari i Politècnic La Fe
Valencia, València, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC18G006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.