RECRUITINGPhase 3INTERVENTIONAL
A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)
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
About This Trial
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.
Who May Be Eligible (Plain English)
Key Who May Qualify:
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 Who Should NOT Join This Trial:
1. Patients have been diagnosed with any other autoimmune conditions (where your immune system attacks your own body) 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 weakened immune system.
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
BIOLOGICAL
Telitacicept
Subcutaneous injection
DRUG
Placebo
Subcutaneous injection
Locations (20)
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