Summary:
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.