A Study of Telitacicept for Generalized Myasthenia Gravis (UPSTREAM MG)
This study is testing a drug called telitacicept for people with generalized myasthenia gravis (gMG), an autoimmune disease that causes muscle weakness. Telitacicept works by targeting certain proteins that help B cells (a type of immune cell) grow and mature, which may help reduce autoimmune symptoms. You might receive telitacicept or a placebo (an inactive substance) as a shot under the skin. The main goal is to see how much your Myasthenia Gravis-Activities of Daily Living (MG-ADL) score changes after 24 weeks. To join, you must be at least 18 years old and have a confirmed diagnosis of gMG. The study is currently not recruiting, and aims to enroll 180 participants.
- Study design
- This is a randomized, double-blind study, meaning you will be randomly assigned to receive either telitacicept or a placebo, and neither you nor your doctors will know which you are receiving. It is a Phase 3 study, and plans to include 180 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at Week 24, but the study includes an open-label extension, suggesting follow-up beyond this point.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)
At a glance
Conditions
Where it's being run
111 sites across 76 statesWho to contact
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What this trial measures
- Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at Week 24Week 24
The MG-ADL is an 8-item patient-reported outcome measure assessing MG symptoms and their effects on daily activities. Each item in the scale is scored on a 0 to 3 (0=normal, 3=severe disease) point scale. The total score is the sum of all individual item scores ranging from 0 to 24. Higher scores indicate more severe disability due to MG. A decrease from Baseline score indicates improvement.