A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
Graves' disease is an autoimmune condition where the body's defence system mistakenly causes the thyroid gland to produce too much thyroid hormone. This overactive thyroid can lead to shaking, weight loss, tiredness, and sometimes eye swelling or irritation. This Phase 2 trial is testing an experimental medicine called rilzabrutinib in adults aged 18 to 75. Researchers want to see if rilzabrutinib is safe and effective for people with Graves' disease, including those with related eye problems. Everyone who takes part will receive one of two different doses of the study tablet for up to 16 weeks. The whole study takes about 24 weeks and involves up to 13 hospital or clinic visits for health checks, eye exams, and blood tests. This trial aims to find new, targeted ways to treat Graves' disease in the future.
Em resumo
Sobre o que é este estudo?
Graves' disease is an autoimmune condition that causes the thyroid gland in your neck to become overactive. When the thyroid works too fast, it floods your body with hormones, causing symptoms such as a racing heart, weight loss, anxiety, heat intolerance, and trembling hands. In many people, the condition also affects the tissues behind the eyes, leading to eye puffiness, redness, double vision, or bulging eyes.
Current treatments include antithyroid tablets, radioactive iodine, or surgery. While these can help control thyroid hormone levels, they do not always address the root cause in the immune system, and treating eye symptoms can be particularly challenging. This study is testing an experimental drug called rilzabrutinib. It works by blocking specific signals inside immune cells, aiming to calm the immune response that drives both the thyroid and eye symptoms.
This is a Phase 2 study, which means researchers are checking how well the medicine works and learning more about any side effects. By comparing two different daily doses of rilzabrutinib, the research team hopes to discover the safest and most effective dose for future treatment.
Pontos principais
- Tests an experimental drug called rilzabrutinib for adults with active Graves' disease.
- Open to eligible adults aged 18 to 75, with or without thyroid eye symptoms.
- Compares two different active doses of the medicine over 16 weeks of treatment.
- Involves up to 13 clinic visits over approximately 24 weeks.
- Participation is completely voluntary and you can withdraw at any time.
Quem pode ser elegível?
You may be able to take part if you are between 18 and 75 years old and have been diagnosed with active Graves' disease causing an overactive thyroid. You can join whether or not you have thyroid-related eye problems. If you do have eye symptoms, they will be checked at your first visit to ensure they are active and suitable for the study.
You will not be able to join if your overactive thyroid is caused by another condition, such as thyroid nodules or temporary thyroid inflammation. People who have had a severe, sudden thyroid emergency (known as a thyroid storm), or who have a very large goitre pressing on their windpipe, cannot take part.
Additionally, if you have severe eye problems that threaten your sight or require immediate surgery, or if your eye symptoms began more than 9 months ago, this study will not be suitable for you. Both men and women must agree to use reliable contraception during the trial.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Are you between 18 and 75 years of age?
- Have you been diagnosed with Graves' disease with an active overactive thyroid?
- Are your eye symptoms (if any) mild to moderate and started within the last 9 months?
- Are you free from severe complications like a blocked airway or previous thyroid storm?
- Are you willing to attend regular clinic appointments over roughly 6 months?
O que envolve a participação?
Taking part in this study lasts about 24 weeks in total. First, there is a screening period of up to 4 weeks to carry out health checks, blood tests, and eye examinations to confirm the study is safe for you. If you join, you will take rilzabrutinib daily for up to 16 weeks. You will be randomly assigned to take either dose 1 or dose 2. After you finish taking the medicine, there is a 4-week follow-up period to check on your health. Throughout the trial, you will attend up to 13 clinic visits so the medical team can monitor your thyroid levels, eye health, and general wellbeing.
Riscos e benefícios potenciais
Locations (24)
- Investigational Site Number : 0320002Código postal verificadoBuenos Aires, Argentina· Recrutamento
- Investigational Site Number : 0320001Código postal verificadoBuenos Aires, Argentina· Recrutamento
- Investigational Site Number : 0320003Código postal verificadoCórdoba, Argentina· Recrutamento
- Investigational Site Number : 1240003Código postal verificadoCalgary, Canadá· Recrutamento
- Investigational Site Number : 1240002Código postal verificadoSurrey, Canada· Recrutamento
- Investigational Site Number : 1240001Código postal verificadoSherbrooke, Canada· Recrutamento
- Investigational Site Number : 1520001Código postal verificadoConcepción, Chile· Recrutamento
- Investigational Site Number : 1520002Código postal verificadoIquique, Chile· Recrutamento
- Investigational Site Number : 2760002Código postal verificadoEssen, Alemanha· Concluído
- Investigational Site Number : 2760001Código postal verificadoFrankfurt, Alemanha· Concluído
- Investigational Site Number : 3000002Código postal verificadoAthens, Greece· Recrutamento
- Investigational Site Number : 3000001Código postal verificadoAthens, Greece· Recrutamento
Perguntas frequentes
What is rilzabrutinib?
Rilzabrutinib is a new, experimental tablet designed to block certain signals in the immune system to calm down the autoimmune reaction seen in Graves' disease.
Will I receive a placebo (dummy pill)?
No, this trial does not use a placebo. All participants will receive an active dose of rilzabrutinib, testing either dose 1 or dose 2.
Do I have to pay to take part?
No. The study medication and all trial-related appointments and tests are provided free of charge, and travel expenses are often reimbursed.
Posso sair do estudo se mudar de ideia?
Yes. You can leave the study at any point without giving a reason, and your normal medical care will continue as usual.
What happens if my eye symptoms get worse?
The study team includes eye specialists who will examine your eyes regularly. If your vision is at risk, you will receive prompt, appropriate standard treatment.
Como saber mais
Trial Transparency email recommended (Toll free for US & Canada)
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