Clinical trials are important for identifying new medical treatments.¹ This is especially true for thyroid eye disease (TED), which does not have many treatment options.² If you have TED or have previously been diagnosed with Graves’ disease, another thyroid condition where too much thyroid hormone is produced, you may be a candidate for a new clinical study.^1,2

1. A New Clinical Trial Is Studying a Potential Treatment for TED

The spiriTED study is evaluating an investigational study drug for adults with thyroid eye disease. An investigational study drug is a treatment being tested for how well it works to treat a certain health condition.¹ The spiriTED study wants to understand if the investigational study drug can lessen eye bulging, as well as some of the other symptoms of thyroid eye disease. The researchers want to understand if the study drug is more effective than a placebo.³

Before a drug can be approved by the U.S. Food and Drug Administration (FDA), it must be thoroughly studied in clinical trials.¹ Depending on the outcome of the research, an investigational study drug may receive FDA approval and become available to the general public.⁴

There are possible risks to joining a study. Clinical studies may include things that could make participants feel sick or uncomfortable, and in some cases, could be serious. Members of the study team will make sure you understand the risks, including possible side effects. You will also be closely monitored during the study. Ethics boards review and monitor clinical trials to ensure participants are protected.¹

2. If You Have TED, You May Be Eligible To Join the spiriTED Trial

The spiriTED clinical trial is seeking adults to join a study to help advance medical knowledge of thyroid eye disease.¹

To be eligible to join the spiriTED trial, you must meet the following criteria:

• You are between 18 and 80 years old.¹
• You have been diagnosed with TED or have previously been diagnosed with Graves’ disease (an autoimmune disease that causes the thyroid to overproduce thyroid hormone).^1,2
• You currently have moderate to severe TED symptoms (such as double vision, bulging eyes, puffy eyelids, or pain, redness, and a gritty feeling in the eyes).^1,2

This is not a full list of study requirements. The study doctor will review the full requirements of this study with you.¹

Learn more about study requirements

3. Study Participants Might Receive a Placebo

The spiriTED trial is studying TOUR006, an investigational study drug to treat adults with TED. The trial will study how well TOUR006 works compared to a placebo (an inactive substance that looks like the study drug).¹

The study will include three groups. Two of the groups will receive different doses of TOUR006. The third group will receive a placebo. Participants will be assigned to a group randomly. You won’t know which group you’re in and neither will the study staff.¹ This is called a double-blind or double-masked study.⁴

The study is split into two periods. If you receive the placebo in the first period, you may be eligible to receive the investigational study drug in the second period. This will depend on your symptoms and other factors.¹

4. Study Participants Will Receive Care Free of Charge

If you enroll in the spiriTED clinical trial, you will receive all care related to the study at no cost. This includes any procedures and the investigational study drug or placebo. The study will include eye exams, heart tests, lab tests, and other possible procedures.¹

You may be paid a reasonable amount for your time to attend study visits. The trial will last 78 weeks, and you will need to visit a study center 17 times during the trial.¹

There are trial locations around the country, including⁵:

• Tucson, Arizona
• San Diego, California
• Aurora, Colorado
• Miami, Florida
• Louisville, Kentucky
• Livonia, Michigan
• Rochester, Minnesota
• Chapel Hill, North Carolina
• Columbus, Ohio
• Houston, Texas
• San Antonio, Texas
• Morgantown, West Virginia

Reasonable expenses related to travel and lodging, such as meals and parking, will be covered by the trial sponsor, either as a reimbursement or through a travel service. The clinical trial may lead to new products for sale. If this happens, you will not receive payment.³

Find out if you are eligible for the spiriTED study