Disease information
Myasthenia Gravis is an autoimmune disease creating muscle weakness and fatigue. It is estimated that more than 700.000 people worldwide are affected by Myasthenia Gravis. The condition is caused by the immune system destroying signal pathways the nerves and muscles use to communicate with each other. This results in fewer signals reaching the muscles, which creates muscle weakness. Typical symptoms of Myasthenia Gravis disease are often:
- Muscle weakness, especially those that control the eyelids and facial expressions
- Dropping of the upper eyelid
- Double vision
- Shortness of breath
- Difficulties speaking
- Difficulties chewing and swallowing
Symptoms tend to worsen as the affected muscles are used, while rest tends to improve symptoms. However, in general, symptoms progress as time goes on.
Therapeutic background
There is no known cure for Myasthenia Gravis, but treatment can help keep symptoms under control and improve the quality of life in people with Myasthenia Gravis. Some people might not respond well to the standard treatments for Myasthenia Gravis, or the effect of the treatment tapers off quickly. Therefore, new treatments are needed to help improve the symptoms of those people who do not respond well to the standard treatments, or the standard treatment is no longer sufficient to keep their symptoms in control. In this study, the study team will investigate the effectiveness and safety of the study drug Inebilizumab. Inebilizumab is designed to reduce the immune system's ability to attack the signal pathway between nerves and muscles, which may improve communication between the two. This could potentially result in symptom improvement for Myasthenia Gravis patients.
In case you or your loved ones are diagnosed with moderate to severe Myasthenia Gravis disease, you or they might be eligible to participate in this research study and thereby contribute to the possible improvement of treatment options for people who have Myasthenia Gravis disease.
Who can participate?
Candidates who fulfill the following criteria may be eligible for the study:
- You are aged 18 years of older
- You have a Myasthenia Gravis diagnosis
- You have Myasthenia Gravis affecting multiple muscle groups in the body
- You are receiving steroids, a non-steroid immunosuppressive treatment, or a combination of the two
Location(s)
- Cincinnati
- New Haven
- Houston
- Burlington
- Tampa
- Richmond
- Pittsburgh
- Columbus
- Scottsdale
- Fairway
- Aurora
- San Antonio
- Orange
- Augusta
- Salt Lake City
- Charlotte
- Austin
Reimbursement
The study team provides the study drug and any tests required by the study, and you may receive reimbursement for travel related expenses incurred by taking part in the research study until your participation is complete.
Study description
If you qualify for participation in the study, you might receive a placebo instead of the study drug. A placebo is provided instead of the study drug and contains no active ingredients. The use of a placebo is standard practice in research studies investigating the effect of study drugs and is used as a measure of comparison. Your chance of receiving a placebo will be explained by the study staff in advance of your participation.
During the study, you will go through the following periods:
A screening assessment period
The first period you will enter is a screening period. In this period, both clinical and laboratory assessments will confirm your eligibility. For the screening session, you will receive information about the research study, and you will have to visit a study site up to 1 month before you may receive the study drug. At the screening visit, study staff will ask you some questions about your health and perform some tests (e.g., blood test, measure body weight and height, etc.), and an informed consent form must be signed. You can, however, always withdraw your participation if you don’t want to participate.
Treatment period
If you are eligible to participate in a study after the screening period, you will enter a treatment period. The length of the treatment period will depend on which group you fall under based on results of your screening assessment and can range from 26 weeks to 52 weeks. Here you will receive either an Inebilizumab infusion or a placebo. The Inebilizumab infusion will be administered by the local study team at your local study site. To monitor your health, you will also have to visit your local study site during this period.
Voluntary treatment period extension
If you complete the treatment period, you will have the option to opt into a voluntary treatment period extension. All participants who opt into the voluntary treatment period extension will receive inebilizumab treatment and follow up for up to an additional 3 years. Study staff will closely monitor your health throughout your voluntary treatment period extension to ensure your safety.
Follow-up Period
After completion of the study treatment, you will enter a post-treatment follow-up period. During this period, your health will be closely monitored, and the study team will take their final assessments.
Timeline
In the figure below, you can see the maximum duration of the different periods of the research study.
Click “Join Now” on the red button below to find out if you can participate in the study.
