Purpose of this Study
This study lasts about nine to twelve months and includes time to check if a person can join, time to receive treatment, and time for follow up visits. People will come to the clinic for regular visits. At these visits, they may receive medicine through a vein, have blood tests, physical exams, and heart checks, and answer questions about how they feel and what they can do each day.
Everyone will first receive a medicine called efgartigimod, which is already approved for myasthenia gravis. If their symptoms only improve a little, they may then receive a second study medicine called empasiprubart along with the first medicine. This second medicine is being tested to help block parts of the immune system that may still be causing symptoms. After treatment, participants will keep having checkups to make sure the medicines are safe, even if they stop taking them.
Who Can Participate?
Eligibility
People can join this study if they are 18 years old or older and have myasthenia gravis. They must still have symptoms even though they are receiving treatment, and their current treatment should be stable without recent changes. For this specific study, they must have already tried a medicine called efgartigimod and had a partial response, which means the medicine helped some but did not fully control their symptoms.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is being done to see if adding a new medicine called empasiprubart to an existing treatment called efgartigimod is safe and helps people with myasthenia gravis feel better. Researchers want to find out if using both medicines together can reduce symptoms more than using the current treatment alone. The goal is to find better ways to treat people whose symptoms have not fully improved.
Locations
Duke University Hospital
Pickett Road Research
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
DNA11: A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept
Platform Study to Evaluate the Safety, Tolerability, and Efficacy of
Multiple Regimens in Participants With Myasthenia Gravis (ARGX-999-2-MG-2000)
Platform Study to Evaluate the Safety, Tolerability, and Efficacy of
Multiple Regimens in Participants With Myasthenia Gravis (ARGX-999-2-MG-2000)
Principal Investigator
Vern
Juel
Protocol Number
PRO00119141
NCT ID
NCT07284420
Phase
II
Enrollment Status
Pending Open to Enrollment