A Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab Compared to Placebo in Adult Participants with Graves’ Disease
Graves’ disease is an autoimmune condition where the body’s immune system mistakenly attacks the thyroid gland, causing it to produce too much thyroid hormone. This overactive thyroid can lead to symptoms like a racing heart, weight loss, shakiness, and fatigue. Standard treatments include daily anti-thyroid tablets, but these do not cure the underlying immune problem. This Phase 2 clinical trial is investigating whether an experimental drug called felzartamab is safe and effective for adults with Graves’ disease. Participants will receive either felzartamab or an inactive dummy treatment (placebo) given through a drip. The main goal is to see how many people can achieve normal thyroid hormone levels and safely stop taking their standard anti-thyroid tablets by week 24. Doctors will closely track hormone levels, symptoms, and side effects throughout the study.
At a glance
What is this study about?
The thyroid is a small, butterfly-shaped gland in your neck that makes hormones to control your metabolism, energy levels, and heart rate. In Graves’ disease, the immune system produces antibodies that trick the thyroid into making far too much hormone. This is known as an overactive thyroid or hyperthyroidism. It can make everyday life difficult, causing anxiety, tiredness, heat sensitivity, and heart palpitations.
Current treatments usually involve taking daily anti-thyroid medications to block hormone production. While helpful, these medicines only manage the symptoms rather than treating the root cause in the immune system. If tablets fail, patients often have to consider permanent treatments, such as radioactive iodine or surgery to remove the thyroid gland.
Felzartamab is an experimental medicine designed to calm the specific immune cells responsible for Graves’ disease. By targeting the source of the problem, researchers hope it might help reset the immune system and protect the thyroid from ongoing attack.
This trial compares felzartamab with a placebo (a harmless salt-water infusion). By comparing the two groups, researchers can clearly see if felzartamab works better than standard care alone, and whether it could provide a gentler, more direct way to treat Graves’ disease in the future.
Key takeaways
- The study tests whether felzartamab can help adults with Graves’ disease control their condition.
- The main aim is to see if patients can safely stop anti-thyroid tablets by week 24.
- Participants are randomly chosen to receive either felzartamab or a dummy treatment (placebo).
- Regular blood tests and clinic visits will closely monitor thyroid hormones and safety.
- Taking part is completely voluntary and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with Graves’ disease. To take part, participants are usually people who are currently taking anti-thyroid medication to manage their overactive thyroid.
Doctors will carry out health checks and blood tests to make sure it is safe for you to take part. You will need to be able to attend regular hospital appointments for check-ups and treatments.
You might not be able to join if you have certain other serious health issues, active long-term infections, or if you are pregnant or breastfeeding. The study doctor will review your complete medical history to decide if the study is suitable for you.
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.
- I am aged 18 or older.
- I have been diagnosed with Graves’ disease (an overactive thyroid).
- I am currently taking anti-thyroid medication.
- I am able to attend regular clinic visits for blood tests and infusions.
- I am not currently pregnant or breastfeeding.
What does participation involve?
If you decide to join, your participation will last for at least 24 weeks, followed by a monitoring period. You will be placed into one of two groups by chance (randomly): one group receives felzartamab, and the other receives a placebo (salt water). Neither you nor your study doctor will know which group you are in.
The study medicine is given as an infusion through a small tube into a vein (a drip) at the clinic. During your visits, the medical team will carry out health assessments, including blood tests to measure your thyroid hormone levels (such as TSH, FT3, and FT4) and check your general health. Depending on your blood test results, your doctor may slowly lower your dose of regular anti-thyroid tablets to see if your thyroid can stay healthy on its own.
Potential risks and benefits
Locations (2)
- —UnverifiedItaly
- —UnverifiedSpain
Common questions
What is a placebo?
A placebo is a harmless dummy treatment that looks identical to the study medicine, in this case a plain salt-water drip. It helps researchers prove whether any health improvements are truly caused by the new medicine.
Will I have to stop my regular thyroid tablets immediately?
No. Any changes to your normal medicine will be done slowly and carefully by the study doctors, guided by regular blood tests to keep you safe.
How is the study medicine given?
The medicine is given as a liquid drip into a vein in your arm during your hospital visits.
Does taking part cost anything?
No. The study treatment and all trial-related tests are free of charge. Many trials also offer help with travel expenses to and from the hospital.
Can I leave the trial if I change my mind?
Yes. You have the right to withdraw from the study at any point, for any reason, and your normal medical care will continue as usual.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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