DNA07: Novartis CLNP023Q12301 (Myasthenia Gravis) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an investigational drug called iptacopan (the study drug) is safe and has beneficial effects for people who have generalized Myasthenia Gravis (gMG).
Generalized Myasthenia Gravis (gMG)
Who Can Participate in the Study?
Adults ages 18-75 who:
- Are diagnosed with gMG
- Have a positive lab test for AChR+ antibody
- Have been receiving a stable regimen of standard treatment for gMG for at least 6 months before joining the study
For more information, contact the study team at jessica.franceschelli@duke.edu.
What is Involved?
If you choose to join this study, you will need to come to our clinic for screening to confirm your eligibility. Screening can last up to 3-to-4 hours (your study doctor may conduct the screening procedures over more than one visit) and any subsequent visits should take approximately 1-to-3 hours. If you are found to be eligible during screening, you will proceed to the "core" portion of the study.
During the study's core portion, you will:
- Get a random assignment (like a coin flip) to either take the study drug or a placebo (inactive substance with no drug in it)
- Visit our clinic up to 11 times over the course of about 9 months
When the core portion of the study ends, you may have the option to participate in an extension period, if you wish. Anyone who takes part in the extension period will get the study drug regardless of whether or not they received it during the core portion. The extension period will last for up to 25 months and involve up to 15 visits to our clinic.
Study Details
