BridgeMD
New treatment option for Generalized Myasthenia Gravis
Official title A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)
ClinicalTrials.gov ID: NCT06456580
What this study is testing
What is Telitacicept?
Telitacicept is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for generalized myasthenia gravis.
Also referred to as RC18, RC18-L.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female patient aged ≥18 years at screening.
- Patients have prior confirmed diagnosis of gMG with generalized muscle weakness (typical pattern of weakness meeting the clinical criteria for...
- Patients have positive antibodies against AChR or MuSK at screening.
- MG-ADL score ≥6 points at screening and baseline with ocular-related score \<50% of the total score.
- QMG score ≥8 points, and ≥ 4 items score at least 2 points at screening and baseline. Key
You likely can't join if
- Patients have been diagnosed with any other autoimmune disease which can potentially pose a safety or how well it works confounding risk.
- Patients having acute or chronic infection.
- Patients having thymoma within 5 years or received thymectomy ≤6 months prior to screening. Patients with thymoma diagnosed 3-5 years prior to...
- Patients having current or history of primary immunodeficiency.
- Patients having history of malignancy within the last 5 years.
- Patient having prior or continuing diagnosis of serious cardiovascular, liver, kidney, respiratory system, endocrine or hematologic disease.
The study team makes the final eligibility decision.
Where it's taking place
- 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
- The Bronx, New York, United States
- Chapel Hill, North Carolina, United States
+ 76 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 90 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.