Clinical Trial 46740

Boca Raton, FL 33487


Summary:

<b>Myasthenia Gravis - Multiple Locations in the US</b>

If you have been diagnosed with generalized myasthenia gravis (MG), the TAK-079-1005 Study may interest you.

Study Purpose:
The purpose of the TAK-079-1005 Study is to evaluate the safety, tolerability, and effectiveness of an investigational medication, called TAK-079, compared to a placebo in managing symptoms of generalized MG. This study is evaluating if the investigational medication manages symptoms of MG by treating the root cause of the condition. TAK-079 is being compared to a placebo, which looks just like the investigational medication but contains no active medicine. Participants will be chosen at random to receive one of two TAK-079 dosing levels (300 mg or 600 mg) or the placebo. The placebo and TAK-079 are administered as subcutaneous injections (injections under the skin). Participants will be able to continue taking their current MG treatment while in the TAK-079-1005 Study. The dosage level of the current MG treatment must be stable throughout the study unless dose reduction is required.

Participation in the TAK-079-1005 Study can last approximately 36 weeks. This includes a screening period (up to 28 days), dosing period (eight weeks), safety follow-up period (eight weeks), and long-term safety follow-up period (16 weeks). Before an individual can take part in the TAK-079-1005 Study, they will first need to enter the screening period for initial tests and assessments to see if they are eligible to participate. After all necessary tests and assessments have been completed, and if an individual is eligible to participate, they may enter the study and receive TAK-079 or the placebo.

Eligibility Criteria:
Eligible participants must:

  • Be 18 years of age or older
  • Have a diagnosis of MG
  • Be receiving a standard background therapy, and the dose must be expected to remain stable throughout the study
  • Not have an autoimmune disease other than MG

Other protocol-defined inclusion and exclusion criteria may apply.


Qualified Participants Must:


Qualified Participants May Receive:


Available At:

A website has been created to provide more information about the TAK-079-1005 Study. This website provides more information on what to expect if you are enrolled in the study. To learn more, CLICK HERE.

To view a list of participating research sites click here.

 


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.