Graves’ disease is an autoimmune disorder that affects the thyroid, a small gland located at the front of the neck. The thyroid regulates the body’s metabolism, heart rate, and body temperature. In Graves’ disease, the immune system mistakenly attacks the thyroid, causing it to produce too much thyroid hormones. The excess thyroid hormones can cause a variety of symptoms including weight loss, a fast or irregular heartbeat, feeling nervous or anxious, increased sweating and other general signs of an overactive metabolism. Some people with Graves’ disease also have eye symptoms.

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The VitaliThy study is designed to evaluate how the investigational study drug*  may work (also known as efficacy) and how safe it is for the use in adults living with Graves’ Disease. This study will evaluate the investigational study drug compared to a placebo.

* The investigational study drug, efgartigimod PH20 SC PFS, is not approved by any regulatory agency for use in Graves’ Disease as efficacy and safety have not been established.

Graves' patients may be eligible to participate if they are:

• At least 18 years old
• Not pregnant, or not actively trying to get pregnant
• Diagnosed with Graves’ disease and seropositivity for anti-TSHR antibodies (blood test shows antibodies that target the thyroid-stimulating hormone receptor)

Participating in the study lasts for about 1 to 2.5 years, depending on disease status during the study. During this time, participants may need to visit the study site approximately 34 times.

The study consists of 3 phases:

• Screening phase: Up to 5 weeks before starting the study drug, the study team will assess the eligibility criteria. The study will enroll participants with documented diagnosis of Graves’ disease and suppressed thyroid-hormone after a minimum of 3 months of antithyroid drug (ATD) treatment before screening. Participants must have been receiving a stable antithyroid drug for at least 4 weeks before entering the treatment phase of the study.
  
  
• Treatment phase:
  For the first 6 months of the study, participants will receive either efgartigimod or placebo. Both are called the study drug. There is a 67% that they will receive efgartigimod and a 33% chance they will receive placebo. This will be decided by chance. Neither participant nor the study doctor will know whether they receive efgartigimod or placebo. In case of an emergency, the study doctor can quickly find out whether efgartigimod or placebo has been received. The study doctor may also prescribe an ATD for participants.
  
  After the first 6 months of the study, the treatment assignment will be determined based on participants disease status. At that time, they may be randomly assigned to receive either efgartigimod or placebo, or may be assigned to receive efgartigimod
  
  
• Follow up phase: Participants may need a safety follow-up visit 8 weeks after their final study drug dose