Frequently Asked Questions

What are the symptoms of Graves’ disease (GD)?

Signs may include:^4.

Rapid heartbeat
Having a slight tremor of the hands or fingers.
Feeling nervous and irritable
Enlarged thyroid gland
Bulging eyes, called thyroid eye disease or Graves’ ophthalmopathy
Sensitivity or intolerance to heat with increased sweating
Weight loss, despite increased appetite
Diarrhea
Hair loss/change in texture
Menstrual changes
Difficulty sleeping
Muscle weakness
Thick, discolored skin often on the shins or tops of the feet, called Graves’ dermopathy

4. Source: https://www.mayoclinic.org/diseases-conditions/graves-disease/symptoms-causes/syc-20356240

Who may be a good candidate to apply for the FORWARD Graves’ disease study?

This trial is enrolling people aged 18 to 75 who:

Have been diagnosed with Graves’ disease
Have been taking antithyroid drugs for at least 3 months by the time they begin the study
Have not undergone Radioactive Iodine Therapy or complete thyroidectomy

What are the benefits of participating?

Clinical trials are the only way to investigate potential new treatments. However, there is no guarantee that you will benefit from receiving the study treatment. Your Graves’ disease may get better, get worse, or may stay the same. However, by participating, patients are helping scientists advance research and improve treatments for Graves’ disease. Participants will also receive attentive care from a team highly skilled in the treatment of Graves’ disease throughout the trial.

Are there any costs to participate in this study?

No, there is no cost to participate. For qualified participants who choose to be in this study, study treatment will be provided at no cost. There will be no charge for any tests, examinations, nor visits done as part of this study. Participants may be reimbursed for travel costs and out of pocket expenses. They will also receive compensation for their time and effort.

Are there any risks to participating?

In any clinical study for a new drug, there are potential risks, such as side effects of the drug or risks from the study activities. The study staff will explain these potential risks before participants decide whether to participate, and address any concerns.

What is being researched in the trial?

In this study, researchers are testing whether an investigational drug called IMVT-1402 will help people with Graves’ disease. “Investigational” means that the drug has not been approved for use in patients, except in a clinical study. The study drug is designed to work differently from antithyroid drugs, by targeting the underlying cause of Graves’ disease. Since Graves’ disease (GD) is an autoimmune disease caused by antibodies, a possible disease-modifying approach researchers are examining is to target a receptor that would potentially lead to antibody reduction.

Does qualifying ensure my participation in the study?

Before a potential participant decides whether to take part in the study, the study staff will review the informed consent form with them and answer any questions. Once the consent form has been signed by the participant, the screening period of the study begins. During this period, the staff will review medical history and conduct any relevant assessments. Participants who meet all of the study criteria will be invited to participate.

Can I change my mind about participating in the study?

Being part of the FORWARD study is your choice and you are free to leave at any time, without giving a reason, and without affecting your medical care. If you decide to leave the study early, you may be asked to attend one more study visit so the study doctor can assess your health.

What will happen during the study?

The FORWARD trials are evaluating whether an investigational treatment, called IMVT-1402, can address the underlying cause of Graves’ disease, and potentially normalize thyroid hormone levels. This study includes 3 parts: Screening, Treatment, and Follow-Up. The investigational treatment is given as injections under the skin, known as subcutaneous injections.

What is the likelihood that I receive the placebo?

You will be assigned by chance to receive either the investigational treatment (IMVT-1402) or a placebo, which is an inactive treatment that looks the same, but does not contain any active ingredient. Neither you nor the study doctors will know which treatment you are taking, this is known as a “double-blinded study.” Since there are two treatment groups that receive IMVT-1402 and one treatment group that does not, there is a “2 in 3” chance of participants receiving IMVT-1402, and a “1 in 3” chance of participants receiving the placebo.

What if I have more questions?

If you are interested in learning more, please contact us at any time. You may email us at help@clinicalenrollment.com.

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