Purpose of this Study
In this study, people will be placed into one of two groups by chance, like flipping a coin. One group will receive a medicine called nipocalimab, and the other group will receive a placebo, which looks the same but has no medicine. The medicine is given through a vein every two weeks for about 24 weeks. During the study, participants will have clinic visits, blood tests, exams, and answer questions about how they feel. After this part is finished, some people may have the option to continue in another part of the study and receive the study medicine.
Who Can Participate?
Eligibility
People can join this study if they are 18 years old or older and have a disease called generalized myasthenia gravis, which causes muscle weakness. They must have a blood test that shows certain antibodies linked to the disease. They must have moderate symptoms that are not fully controlled by their current treatment. They should be on a steady treatment plan, or they may have stopped treatment because it did not work well or caused side effects.
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 testing a new medicine called nipocalimab to see if it can help people with a disease called generalized myasthenia gravis. This disease causes muscles to become weak. Researchers want to find out if this medicine can improve symptoms better than a placebo, which has no active drug. They also want to make sure the medicine is safe for patients.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
DN54-MOM-M281-011
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to
Adults with Generalized Myasthenia Gravis
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to
Adults with Generalized Myasthenia Gravis
Principal Investigator
Vern
Juel
Protocol Number
PRO00108322
NCT ID
NCT04951622
Phase
III
Enrollment Status
Open to Enrollment