Purpose of this Study
This study will last about 35 weeks and has three parts: Screening, Dosing, and Follow-up. It is a double-blind study, which means neither you nor the doctors will know if you get the real medicine or a placebo. The medicine or placebo will be given as two shots under the skin.
After you agree to join, treatment will start. There will be phone calls at weeks 3, 5, 7, 9, and 11 to check on your medicine and any side effects. You will have regular health checkups, physical exams, and tests like ECGs to check your heart. You will also answer short surveys about your symptoms, energy, mood, and work.
You will come back at 3, 6, and 12 months for blood tests. Over the whole study, about one cup of blood will be taken. These tests will check your health, medicine levels, antibodies, and screen for diseases like HIV, hepatitis, and tuberculosis.
Who Can Participate?
Eligibility
This study is for adults between 18 and 75 years old who have a sickness called generalized myasthenia gravis, or gMG. People in the study need to be able to give themselves a shot or have someone help them. Women who cannot have babies can join. Women who can have babies must use birth control during the study. Men must also use birth control if their partner can have babies, and keep using it for 90 days after their last dose of medicine.
Age Range
18-75
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Looking for Healthy Participants
No
What is Involved?
Description
The purpose of this study is to see if a new medicine called IMVT-1402 is safe and works well for people who have a sickness called Generalized Myasthenia Gravis, or gMG. This sickness makes muscles weak. What doctors learn from this study may help treat people with gMG in the future.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
DNA09 - A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-
Blind Study to Assess the Efficacy and Safety of IMVT-1402 in
Patients With Mild to Severe Generalized Myasthenia Gravis
Blind Study to Assess the Efficacy and Safety of IMVT-1402 in
Patients With Mild to Severe Generalized Myasthenia Gravis
Principal Investigator
Shruti
Raja
Protocol Number
PRO00117985
NCT ID
NCT07039916
Phase
III
Enrollment Status
Open to Enrollment