A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
This research study is looking into a new medicine called rilzabrutinib for adults who have Graves' disease. Graves' disease causes your thyroid gland to be too active, and sometimes it can affect your eyes (called Graves' orbitopathy). We are testing two different doses of rilzabrutinib to see how effective and safe it is. Participants will be divided into groups, with each group receiving a different dose, to compare their effects. This is a Phase 2 study, which means it's an early stage of testing to get more information about the drug before larger studies are done. The study will involve screenings, a treatment period, and a follow-up period.
At a glance
What is this study about?
This study is a medical research project focused on Graves' disease. Graves' disease is an illness where your body's immune system mistakenly attacks your thyroid gland, making it produce too many thyroid hormones. This can lead to symptoms like feeling tired, losing weight, feeling anxious, and having a fast heartbeat. Sometimes, Graves' disease can also affect the eyes, causing problems like bulging eyes, irritation, and double vision (this is called Graves' orbitopathy).
The main goal of this study is to investigate a new medicine called rilzabrutinib. We want to understand if this medicine can help control Graves' disease and its symptoms, including the eye problems, and whether it is safe for people to use. We're testing two different amounts (doses) of the medicine to see which might be best.
This is a Phase 2 study. In simple terms, this means we are still in the earlier stages of understanding this new medicine. We're gathering more information about how it works, what side effects it might have, and the right dose to use, before it can be considered for wider use. It's an important step in potentially finding new and better treatments for Graves' disease.
Key takeaways
- This study is testing a new medicine, rilzabrutinib, for adults with Graves' disease.
- It aims to see if the medicine is effective and safe at two different doses.
- The study includes people with Graves' disease, with or without related eye problems.
- Participation involves screening, treatment (up to 16 weeks), and follow-up.
- This is an early-stage (Phase 2) study.
- You can withdraw from the study at any time.
Who may be eligible?
This study is open to adults aged 18 to 75 who have been diagnosed with Graves' disease and currently have an overactive thyroid. Some participants will also have eye problems related to Graves' disease (Graves' orbitopathy) that are active and meet certain criteria, such as specific eye measurements or symptoms like double vision. Both men and women can take part, and if you are able to have children, you will need to use contraception according to local guidelines during the study.
However, there are also reasons why people might not be able to join. For example, if your overactive thyroid is caused by something other than Graves' disease, or if you have a history of a very severe thyroid condition called thyroid storm, you wouldn't be able to participate. Also, if your thyroid gland is so enlarged it's blocking your airway, or if you need immediate eye surgery for your Graves' eye disease, or if your eye problems are very severe and affecting your vision, you wouldn't be eligible. The study also cannot include those who developed their Graves' eye disease symptoms more than nine months ago.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 75 years old?
- Have you been diagnosed with Graves' disease and currently have an overactive thyroid?
- If you have Graves' eye problems, are they active and did they start within the last 9 months?
- Do you not have other causes for an overactive thyroid, like toxic goiter?
- Do you not need immediate eye surgery or have severely reduced vision due to Graves' eye disease?
- Are you able to follow contraception guidelines if needed?
What does participation involve?
If you decide to take part in this study, you would first go through a screening period that could last up to 4 weeks. During this time, doctors would do tests to make sure the study is suitable for you. If you qualify and choose to continue, you would then enter the treatment period, which lasts up to 16 weeks, where you would receive the study medicine. After that, there will be a follow-up period of 4 weeks. In total, you could have up to 13 visits to the clinic throughout the entire study.
Potential risks and benefits
Locations (13)
- Investigational Site Number : 1240003Verified postcodeCalgary, Canada· Recruiting
- Investigational Site Number : 1240002Verified postcodeSurrey, Canada· Recruiting
- Investigational Site Number : 1240001Verified postcodeSherbrooke, Canada· Recruiting
- Investigational Site Number : 2760002Verified postcodeEssen, Germany· Recruiting
- Investigational Site Number : 2760001Verified postcodeFrankfurt, Germany· Recruiting
- Investigational Site Number : 3800001Verified postcodeMilan, Italy· Recruiting
- Investigational Site Number : 3800003Verified postcodePalermo, Italy· Recruiting
- Investigational Site Number : 3800002Verified postcodePisa, Italy· Recruiting
- Investigational Site Number : 7240002Verified postcodeBarcelona, Spain· Recruiting
- Investigational Site Number : 7240001Verified postcodePamplona, Spain· Recruiting
- Investigational Site Number : 7240004Verified postcodeSeville, Spain· Recruiting
- Investigational Site Number : 8260003Verified postcodeMilton Keynes, United Kingdom· Recruiting
Common questions
What is Graves' disease?
Graves' disease is an immune system problem that causes your thyroid gland to make too much thyroid hormone. This is called an overactive thyroid.
What is Graves' orbitopathy?
This is when Graves' disease affects your eyes, leading to symptoms like bulging eyes, dryness, or double vision.
What does 'Phase 2 study' mean?
It means this is an early stage of research where we are testing the new medicine in people to see if it works and what the best dose is, and to check for safety, before it can be tested in larger groups.
How long will I be involved in the study?
The study involves a screening period of up to 4 weeks, a treatment period of up to 16 weeks, and a follow-up period of 4 weeks. The total time could be around 24 weeks.
Will I know if I'm getting the actual medicine or a dummy pill?
This study is testing different doses of the active medicine. You will be in one of two groups, each receiving a different dose of rilzabrutinib. No dummy pills (placebo) are being used in this specific study.
How to find out more
Trial Transparency email recommended (Toll free for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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