The spiriTED Study is evaluating an investigational study drug called TOUR006 to find out how it works compared to placebo in adults with TED. Placebo is a substance that looks like the investigational study drug but has no active drug in it. The goal of the study is to assess the effectiveness of the investigational drug to reduce proptosis (bulging of the eye) and other symptoms of TED.
You may be able to participate in the study if you meet the following requirements:
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Age
18-80
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Confirmed diagnoses of Graves' Disease
Currently experiencing moderate to severe symptoms of TED
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No current need for eye surgery
*This is not a complete list of study eligibility requirements. The study doctor will review the full requirements for this study with you.
If you qualify, participation in the spiriTED Study will last about 78 weeks and you will be asked to visit the study center at least 17 times during this period.
This study consists of an optional Prescreening Period (up to 2 weeks), a Screening Period (up to 4 weeks), a 24-week Primary Study Period (Period A), and a 48-week Extension Period (Period B).
Laboratory tests, eye examinations and assessments, heart tests, questionnaires, and other procedures will be conducted as part of this study
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
Participants will receive all study-related procedures and the investigational study drug or placebo comparator at no cost.
You may be eligible for reasonable compensation for your time to attend study visits and/or reimbursement for certain approved study-related costs, such as transportation.
There are risks involved with any clinical study, which may include side effects. Your study doctor will review the risks with you, and you will be closely monitored throughout the study.
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Take the pre-screener to find out if you may be eligible!
Take the Pre-ScreenerAn investigational study drug is a substance that is being tested in a clinical study and has not been approved by regulatory agencies, such as the United States (US) Food and Drug Administration (FDA) or others. Every investigational study drug is reviewed by an ethics committee for testing in people.
The investigational study drug, known as TOUR006, is a monoclonal antibody. That means it is a laboratory-made antibody.
If you are eligible to enroll in the spiriTED Study, you will be randomly assigned (by chance) to receive 1 of 2 different doses of the investigational study drug (TOUR006) or placebo. There is a 2-in-3 chance you will receive study drug, and a 1-in-3 chance you will receive placebo. You and your study doctor will not know your study group assignment.
Thyroid eye disease (TED) is an inflammatory condition of the eye and surrounding tissues. The 2 phases of TED include the active phase (currently experiencing symptoms) and the stable phase (some initial symptoms may have resolved). TED is often related to Graves’ disease, an autoimmune disease where the immune system attacks healthy tissue in the thyroid gland.
Some of the TED symptoms are:
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, participants must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures participants will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational study drug or placebo, and having assessments to monitor your health. You can still visit your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research study, contact a study clinic near you.
Use the map and site list below to find the study clinic closest to you. You may be eligible for travel assistance if there are no study locations near you. Contact the study clinic to learn more.