A Study of TAK-079 in People With Generalized Myasthenia Gravis
Status:
Recruiting
Trial end date:
2022-06-25
Target enrollment:
Participant gender:
Summary
Myasthenia gravis is an autoimmune condition that causes muscle weakness. Autoimmune means
the body makes antibodies that attack its own cells and tissues. These types of antibodies
are also known as autoantibodies. People with generalized myasthenia gravis have a weakness
in many muscles.
TAK-079 is a medicine to help people with generalized myasthenia gravis.
The main aim of this study is to check if people with generalized myasthenia gravis have side
effects from 2 doses of TAK-079. Other aims are to learn if TAK-079 improves their clinical
condition and lowers their autoantibody levels.
At the first visit, the study doctor will check if each person can take part. For those who
can take part, participants will continue with their standard medicines for this condition
during the study. Each participant will have a check-up by the study doctor.
Then, the participants will have 1 of 3 treatments:
- A low dose of TAK-079.
- A high dose of TAK-079.
- A placebo. In this study, a placebo looks like TAK-079 but does not have any medicine in
it.
Participants will not know which treatment they received, nor will their study doctors. This
is to help make sure the results are more reliable.
For each treatment, participants will receive injections just under the skin, once a week for
8 weeks. The study doctors will check for side effects from the study treatments. The study
doctors can stop or delay the injections in each participant if needed.
Then, the study doctors will continue to check for side effects for up to 24 weeks after
treatment. They will also check the clinical condition of the participants, including their
autoantibody levels.