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

RecruitingPhase 3

Sponsor: Vor Biopharma

Conditions: Generalized Myasthenia Gravis

Interventions: Telitacicept, Placebo

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (111)

Scottsdale, Arizona, United States
Los Angeles, California, United States
Orange, California, United States
San Francisco, California, United States
Boca Raton, Florida, United States
Miami, Florida, United States
Port Charlotte, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
O'Fallon, Illinois, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Foxborough, Massachusetts, United States
East Lansing, Michigan, United States
Grand Rapids, Michigan, United States
Columbia, Missouri, United States
New York, New York, United States
New York, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
Tigard, Oregon, United States
Dallas, Texas, United States
Houston, Texas, United States
Greenfield, Wisconsin, United States
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Mendoza, Mendoza Province, Argentina
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