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Clinical Trials in the USA / NCT06456580
Recruiting Phase 3

A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)

NCT06456580 · tracked via the Priya Life Science USA tracker
Sponsor
Vor Biopharma
Phase
Phase 3
Started
2024-07-17
Last updated
2026-06-18

Condition(s) studied

Generalized Myasthenia Gravis

Investigational drug(s) / intervention(s)

TelitaciceptPlacebo

Telitacicept: Subcutaneous injection

Placebo: Subcutaneous injection

Study summary

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: 1. Male or female patient aged ≥18 years at screening. 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. Key Exclusion Criteria: 1. Patients have been diagnosed with any other autoimmune disease which can potentially pose a safety or efficacy confounding risk. 2. Patients having acute or chronic infection. 3. Patients having thymoma within 5 years or received thymectomy ≤6 months prior to screening. Patients with thymoma diagnosed 3-5 years prior to screening may be eligible if thymoma was at a localized stage and definitively treated with complete surgical resection. 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, liver, kidney, respiratory system, endocrine or hematologic disease.

Primary outcome measure(s)

Trial sites (111)

FacilityCityRegionStatus
HonorHealth Neurology - Bob Bové Neuroscience Institute Scottsdale Arizona Recruiting
University of Southern California Los Angeles California Recruiting
University of California Irvine Orange California Recruiting
University of California San Francisco (UCSF) San Francisco California Recruiting
SFM Clinical Research Boca Raton Florida Recruiting
Allied Biomedical Research Institute (ABRI) Miami Florida Recruiting
Medsol Clinical Research Center Port Charlotte Florida Recruiting
University of South Florida Health (USF Health) Tampa Florida Recruiting
Wellstar MCG Health Medical Center Augusta Georgia Recruiting
Hospital Sisters Health System Medical O'Fallon Illinois Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
University of Kentucky Lexington Kentucky Recruiting
University of Louisville Physicians Louisville Kentucky Recruiting
Neurology Center of New England Foxborough Massachusetts Recruiting
Michigan State University Clinical Center East Lansing Michigan Recruiting
Trinity Health - Grand Rapids Hospital Grand Rapids Michigan Recruiting
UM Health Care - Neurology and Sleep Disorders Clinic Columbia Missouri Recruiting
Hospital for Special Surgery New York New York Recruiting
Mount Sinai Health System New York New York Recruiting
Montefiore Medical Center The Bronx New York Recruiting
University of North Carolina Hospitals - Neurology Clinic Chapel Hill North Carolina Recruiting
University of Cincinnati Health Physicians - Clifton Cincinnati Ohio Recruiting
Empower Clinical Research Tigard Oregon Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
Houston Methodist Neurological Institute Houston Texas Recruiting
Center for Neurological Disorders, S.C. - Greenfield - Gamma Therapeutic Center Greenfield Wisconsin Recruiting
STAT Research S.A. Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Hospital Italiano de Buenos Aires Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Hospital General de Agudos José María Ramos Mejía Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Fundación Scherbovsky Mendoza Mendoza Province Recruiting
INECO Neurociencias Oroño Rosario Santa Fe Province Recruiting
Concord Repatriation General Hospital Concord New South Wales Recruiting
Townsville University Hospital Douglas Queensland Recruiting
Gold Coast University Hospital Southport Queensland Recruiting
Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg Leuven Flemish Brabant Recruiting
Centre Hospitalier Régional de la Citadelle Liège Liège Recruiting
Instituto de Neurologia de Curitiba Curitiba Paraná Recruiting
Hospital São Lucas da PUCRS Porto Alegre Rio Grande do Sul Recruiting
Universidade Estadual de Campinas Campinas São Paulo Recruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Ribeirão Preto São Paulo Recruiting

+ 71 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06456580 on ClinicalTrials.gov ↗ ← All trials in the USA