Potential Treatment for Generalized Myasthenia Gravis (gMG)

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

MG is a rare autoimmune disease affecting about 700,000 people worldwide. The current therapy for MG focuses on treating symptoms caused by the disease, such as muscle weakness. The UPSTREAM MG Clinical Study will test how safe and effective a study drug called telitacicept may be in adults living with generalized myasthenia gravis (gMG).

Why do researchers think this study treatment might be promising?

New clinical studies to evaluate MG treatment are shifting from symptom relief to targeting the immune system when it is overactive in an abnormal way, which is the root cause of MG. The UPSTREAM MG Clinical Study is testing the safety and efficacy of a study drug that targets the immune system to see what effect it may have on the daily lives of those who have MG.

Timeline

Screening

Participants are evaluated to confirm eligibility

Approximately 4 Weeks
1 Visit

Double Blind Period

Weekly injections of active study drug or placebo - either on-site or at home.

24 Weeks
24 Visits

Open Label Extension

Optional study extension where all patients can receive the study drug. The open label extension will continue until the drug is approved.

48+ Weeks
12+ Visits

Follow-up

Participants are monitored after completing treatment.

8 Weeks
2 Visits