A Potential New Approach
to Myasthenia Gravis Treatment

If you or someone you know has been diagnosed with generalized myasthenia gravis (gMG) and are continuing to experience symptoms despite current treatment, you may be eligible to participate in the VIVACITY-MG Study. The study is evaluating the safety and efficacy of an investigational drug to assess if the drug has the potential of improving the clinical signs and symptoms of MG, and thus quality of life.

About MG


what is myasthenia gravis

Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disease which affects skeletal muscles that are responsible for eye movements, breathing, and moving parts of the body, resulting in muscle weakness and fatigue.

All muscle movements are triggered by nerve cells. In healthy muscles, nerve endings transmit signals that are received by muscle receptors to cause muscle contraction. But in MG, the immune system mistakenly attacks those receptors by producing anti-receptor antibodies (most commonly acetylcholine receptor [AChR] or muscle-specific kinase [MuSK] antibodies) that can block or destroy these muscle receptors, preventing the signals from effectively reaching the muscles. Over time, this may lead to symptoms such as limb weakness, drooping eyelids, and double vision, as well as difficulties with chewing, swallowing, speech, and breathing.

While many patients with MG may be managed with current therapies, some patients may 1) fail to respond adequately despite multiple therapies, 2) not tolerate these therapies, and/or 3) have conditions that do not allow the use of these therapies. These patients may continue to experience profound muscle weakness and severe disease symptoms that limit their functions and their quality of life. Research is needed to develop the new treatment options for patients with MG.

The VIVACITY-MG Study


The VIVACITY-MG Study is a clinical research study for people with generalized MG. The purpose of this study is to determine whether the investigational drug is safe and effective in the treatment of this disease.

Vivacity-MG myasthenia gravis clinical trial is four months long
4

Length of Participation

Approximately four months

myasthenia gravis clinical trial sessions
9

Number of Study Visits

Nine total visits

  • One screening visit
  • Six visits during study treatment period
  • Two follow-up visits
myasthenia gravis drug clinical trial
5

Study Drug Delivery

Study drug will be administered via two-hour IV infusions every two weeks (Five total infusions)

refractory myasthenia gravis patient
myasthenia gravis clinical trial participants

Investigational Drug vs. Placebo

Study participants will be randomly assigned (like flipping a coin) to one of five study drug groups.

  • Four of the five groups (80%) will receive the investigational drug
  • One of the five groups (20%) will only receive placebo (an inactive substance)

VIVACITY-MG is a double-blinded study, which means that neither the study doctor nor the study participants will know who is receiving the investigational drug or placebo.

myasthenia gravis clinical trial procedure

Tests, Assessments, and Procedures

In addition to receiving study drug, all study participants will regularly undergo a number of tests during study visits.

These are done to monitor study participants’ health and to help researchers determine the effects (if any) of the investigational drug.

Vivacity-MG is an open extension myasthenia gravis clinical trial

Open-Label Extension

Study participants in the VIVACITY-MG Study may have the option to enroll in a long-term extension study, where they will all receive the investigational drug for an additional length of time.

Download the Study Brochure

For more information about the VIVACITY-MG Study, download our Study Brochure.

Download Download

About the Investigational Drug


In MG, the body’s immune system creates antibodies which block and attack the receptors between the nerve cells and the muscles – causing muscle weakness and fatigue. The investigational drug is being studied to see if it can lower the level of these harmful antibodies in the body, which may prevent them from blocking or destroying the muscle receptors. Researchers believe the investigational drug may help improve nerve-to-muscle signals and muscle function, the clinical signs and symptoms of MG, and quality of life.

About the Investigational Drug

The investigational drug is delivered via infusion (a needle connected to a tube) and will be given along with standard treatment for MG.

myasthenia gravis drug
Study participants will be randomly assigned to either a specific dose of the investigational drug or placebo (an inactive substance).
One in five myasthenia gravis research study participants will receive a placebo
The chances of receiving the investigational drug are 80% (four-in-five chances) and placebo are 20% (one-in-five chance). Study participants will have an equal chance of being assigned to any of the five treatment groups.
Vivavity-MG myasthenia gravis drug comes in 5 doses
During the study treatment period, study participants will receive five infusions of their assigned study drug (every two weeks for eight weeks), along with study-related care and assessments. Each infusion will take approximately two hours.

Potential Risks and Benefits

The investigational drug is not approved by the FDA or any other Regulatory agency. It is not known if the investigational drug works or is safe. Your health may get better, worse, or not change at all. Please speak with your study doctor for more information about the potential risks and discomforts you may experience by participating in this study.

About Clinical Studies


Clinical studies allow us to investigate the potential of investigational drugs. All investigational drugs must be tested in clinical studies (also known as clinical research studies) before they are approved and available for use. This is done by testing on study participants, but only after the investigational drug in question has gone through extensive testing in the laboratory. There are guidelines, laws, and protections for those participating in clinical studies. Participation in a study is completely voluntary, and participants can choose to stop participating at any time and for any reason.

Clinical research studies help scientists and doctors explore whether a medical strategy, investigational drug, or device is safe and effective. Study participants are critically important to clinical research. Without people willing to volunteer their time for medical research, it would be almost impossible to evaluate potential new treatments for medical conditions. To learn more about clinical research studies, click here.

Take the prescreener

Take our brief online questionnaire to see if you may be eligible to participate.

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