About this study
Do you suffer from Grave’s Disease?
This clinical research study is evaluating an experimental treatment for Grave’s Disease.
The main purpose of this study is to look at how the investigational medication affects thyroid function in adults with Graves’ Disease (GD). The study will also check whether this medication is safe and well tolerated. It will look at how it is distributed and eliminated in the body, how it changes antibody levels, and how the immune system responds to it.
The total study duration for participants ranges from 63 to 135 weeks, depending on the response to treatment.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your health to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others with Grave’s Disease, and whether it will be made widely available to all Canadians. Study volunteers are an important part of moving medical care forward.
Who may qualify
You may qualify if
- Are at least 18 years of age when signing the Informed Consent document.
- Have a documented diagnosis of Grave’s disease with TRAb (anti-thyrotropin receptor antibody) levels >=ULN (upper limit of normal) at screening
- Have active hyperthyroidism due to Grave’s disease with TSH (thyroid-stimulating hormone) <0.1 mIU/L at screening
- Have been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 months before screening
This study may not be a fit if
- Have a history of hyperthyroidism not caused by Grave’s disease (eg, toxic adenoma or toxic multinodular goiter)
- Have a history of RAI (radioactive iodine) therapy or received a total thyroidectomy
- Have taken a T3- or T4-containing medication or supplement (eg, levothyroxine, liothyronine, desiccated thyroid preparations, or thyroid-support supplements) <6 weeks before screening
- Have any complication of hyperthyroidism or underlying medical condition that would put you at undue risk. This includes arrhythmia or tachyarrhythmia related to Grave’s disease, such as atrial fibrillation or atrial flutter not sufficiently controlled with medications.
- Have Graves’ orbitopathy/Thyroid Eye Disease (GO/TED) requiring systemic therapy (eg, corticosteroids), orbital injections, orbital surgery, or orbital radiation, or expected immediate surgical intervention and/or planned corrective surgery/irradiation or medical therapy during the study
Every study has additional criteria the research site will review with you.
What participation may involve
- Regular visits with the study team at no cost
- Study assessments and health monitoring throughout
- Check-ins between visits
- Informed consent before anything begins — questions welcome
Time commitment: ≈6 months — confirmed by the research site. The full visit schedule is explained during informed consent.
What participants may receive
- Study-related care from a physician-led team
- Study assessments at no cost
- Reimbursement for reasonable travel, where applicable
Specifics vary by study and site, and are never a guarantee of benefit. Being in a study is not a substitute for regular medical care.