Ongoing Clinical Trials for Graves’ Disease
There are currently 6 clinical trials underway investigating new treatments for Graves’ disease, an autoimmune disorder that causes the thyroid gland to produce excessive thyroid hormones. These trials are taking place across multiple European countries and are testing various innovative approaches including new medications administered by injection, oral therapies, and comparisons of existing treatment methods. The studies focus on controlling thyroid hormone levels, managing symptoms, and exploring alternatives to standard treatments.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Espagne
- France
- Germany
- Study on the Effectiveness and Safety of IMVT-1402 for Adults with Graves’ Disease
- Study on the Effects and Safety of Rilzabrutinib for Adults with Graves’ Disease
- Study on the Effects of Batoclimab for Patients with Graves’ Disease
- Study on the Effects of Satralizumab for Patients with Moderate-to-Severe Thyroid Eye Disease
- Hungary
- Italy
- Study on the Effectiveness and Safety of IMVT-1402 for Adults with Graves’ Disease
- Study on the Effects and Safety of Rilzabrutinib for Adults with Graves’ Disease
- Study Comparing Thiamazole and Sodium Iodide (131I) for Treating Hyperthyroidism in Patients with Graves’ Disease and Active Graves’ Orbitopathy
- Study on the Effects of Satralizumab for Patients with Moderate-to-Severe Thyroid Eye Disease
- Poland
- Portugal
- Spain
Study on the Effectiveness and Safety of IMVT-1402 for Adults with Graves’ Disease
This trial is testing IMVT-1402, a new medication given as an injection under the skin, to see if it can help adults with Graves’ disease maintain normal thyroid function. The study will run for up to 52 weeks, with the main treatment period lasting 26 weeks.
Who can join: Adults between 18 and 75 years old who have been previously diagnosed with Graves’ disease and currently have low TSH levels (below 0.1 mIU/L). Participants must already be taking antithyroid drugs for at least 3 to 6 months at specified doses. This includes those taking at least 20 mg daily of methimazole or equivalent doses of similar medications, or those who have been on treatment longer with at least 10 mg daily of methimazole or equivalent.
Who cannot join: People with other serious health conditions that might interfere with the study, those who are pregnant or breastfeeding, anyone who participated in another clinical trial within the last 30 days, those with a history of drug or alcohol abuse in the past year, people with uncontrolled high blood pressure, severe liver or kidney disease, heart disease, known allergies to the study medication, or those who had major surgery within the last 3 months.
Main focus: The study aims to determine if IMVT-1402 can help patients achieve and maintain normal thyroid hormone levels (becoming euthyroid) without needing to increase their antithyroid medication. Researchers will monitor hormone levels including T3, FT4, and TSH throughout the treatment period and follow-up phase to see if participants can reduce or stop their other medications while keeping hormone levels normal.
Study on the Effects and Safety of Rilzabrutinib for Adults with Graves’ Disease
This open-label trial evaluates rilzabrutinib, an oral medication taken as a tablet, for treating adults with Graves’ disease. The study is particularly interested in participants who also have eye-related symptoms known as Graves’ orbitopathy.
Who can join: Adults with confirmed Graves’ disease and active hyperthyroidism (overactive thyroid producing too much hormone). Some participants will have active Graves’ orbitopathy affecting their eyes, confirmed by an eye examination showing a clinical activity score of 3 or higher in the most affected eye. These eye problems must include symptoms such as eyelid retraction of 2 mm or more, moderate or severe swelling around the eyes, eye bulging of 2 mm or more, or double vision. Participants must be willing to use effective contraception during the study.
Who cannot join: People who have had their thyroid gland removed (either partially or completely), those who have received radioactive iodine treatment, pregnant or breastfeeding women or those planning pregnancy, individuals with serious liver or kidney problems, those with active infections, people with a history of blood clots, anyone with serious medical conditions the study doctor considers unsafe, those currently using medications that might interact with the study drug, people who participated in another trial within the past 30 days, or those with allergies to the study medication.
Main focus: The study will monitor how rilzabrutinib affects thyroid activity by regularly measuring thyroid hormone levels (Free T4 and Free T3). Researchers will track the percentage change in these hormone levels from starting values and whether they return to normal ranges during treatment. The medication works by targeting a specific part of the immune system called Bruton’s tyrosine kinase (BTK), which is involved in the disease process. For participants with eye symptoms, the study will also evaluate how the medication affects these eye-related problems.
Study Comparing Thiamazole and Sodium Iodide (131I) for Treating Hyperthyroidism in Patients with Graves’ Disease and Active Graves’ Orbitopathy
This trial compares two different treatment approaches for people with Graves’ disease who also have active eye problems (Graves’ orbitopathy). One approach uses antithyroid medication called Tapazole, while the other uses ablative treatments like radioiodine or surgical removal of the thyroid gland (total thyroidectomy). All participants will also receive intravenous glucocorticoids to help with eye symptoms.
Who can join: Adults between 18 and 75 years old with a confirmed diagnosis of Graves’ disease (with positive TSH-R-Ab antibodies in the blood) that has lasted less than 18 months. Participants must have their thyroid levels under control with medication and have moderate-to-severe, active Graves’ orbitopathy lasting less than 18 months. Active eye disease is confirmed by a Clinical Activity Score of 3 or more out of 7 points in the most affected eye. The eye problems must include at least two of the following: eye bulging of 3 mm or more, double vision, or eyelid retraction of 2 mm or more. Blood tests for liver enzymes and muscle enzyme must be no more than 3 times the normal upper limit, and white blood cell counts must be adequate. Women who can become pregnant and sexually active men must use reliable birth control.
Who cannot join: Pregnant or breastfeeding women, people with other serious health conditions that might interfere with the study, those who have had previous treatments that could affect study results, individuals unable to follow study procedures or attend follow-up visits, those currently participating in another clinical trial, people with allergies to the study medications, anyone with a history of non-compliance with medical treatments, individuals with certain mental health conditions, those who recently had surgery or are planning surgery during the study, and people with a history of substance abuse or addiction.
Main focus: The study will run for 24 weeks and aims to compare which treatment approach is more effective in improving eye symptoms. Participants will be randomly assigned to either continue taking Tapazole tablets or receive ablative treatment with radioiodine or thyroid surgery. Throughout the study, eye specialists will conduct regular evaluations measuring changes in eye opening size, eye bulging, eye movements, and visual ability to determine which approach provides better outcomes for managing eye symptoms.
Study on the Effects of Batoclimab for Patients with Graves’ Disease
This open-label trial investigates Batoclimab (also called IMVT-1401), an experimental medication given as an injection under the skin, for treating Graves’ disease. The study focuses on how this medication affects thyroid hormone levels.
Who can join: Men and women aged 18 years or older with confirmed Graves’ disease, as shown by high levels of TSH-R-Ab antibodies in the blood. Participants must have active hyperthyroidism with TSH levels lower than normal and elevated FT3 and FT4 hormone levels (but not more than 5 times the upper limit of normal). People with a specific condition called T3 thyrotoxicosis (where TSH is low and FT3 is high but FT4 is normal) can also join if they have confirmed Graves’ disease. Participants must have been taking antithyroid drugs for at least 12 weeks before screening, starting with a total daily dose of at least 20 mg of methimazole or carbimazole, or at least 100 mg of propylthiouracil.
Who cannot join: People with any other serious health condition that might interfere with the study, pregnant or breastfeeding women, those who had recent major surgery or are planning surgery during the study, individuals taking certain medications that could affect study results, people with a history of drug or alcohol abuse, those who participated in another clinical trial recently, anyone with allergies to the study medication, and individuals unable to follow study procedures or attend required visits.
Main focus: The study will last 24 weeks and aims to see if Batoclimab can help normalize thyroid hormone levels (specifically FT3 and FT4) without requiring an increase in antithyroid drug doses. Researchers will also evaluate whether participants can reduce or stop their antithyroid medications while maintaining normal hormone levels. The medication works by targeting specific parts of the immune system that contribute to excessive thyroid hormone production. Regular monitoring throughout the study will track changes in hormone levels and any side effects that may occur.
Study on the Effects of Satralizumab for Patients with Moderate-to-Severe Thyroid Eye Disease
This trial studies Satralizumab, a medication given as an injection under the skin, for treating moderate-to-severe thyroid eye disease (also called Graves’ orbitopathy). The study will last 48 weeks, with participants randomly assigned to receive either Satralizumab or a placebo.
Who can join: Adults 18 years or older with either active or chronic inactive thyroid eye disease. Those with active disease must have a clinical activity score (CAS) of 3 or more in the affected eye, with symptoms starting within 12 months before the study. Those with chronic inactive disease must have had a CAS of less than 3 in both eyes for at least 6 months, with no new symptoms or worsening for at least 6 months, and an initial diagnosis made more than 12 months but less than 10 years before the study. All participants must have eye bulging (proptosis) of 3 mm or more above normal for their race and gender, along with at least one of the following: eyelid retraction of 2 mm or more, moderate or severe soft tissue changes, or double vision. Thyroid function should be normal or mildly abnormal but under control.
Who cannot join: People without moderate-to-severe thyroid eye disease, those outside the specified age range, and individuals who are part of a vulnerable population requiring special protection or care.
Main focus: The main goal is to see if there is a reduction in eye bulging (proptosis) after 24 weeks of treatment. The study will also examine other factors such as changes in eye appearance, quality of life, and any side effects. Participants will receive regular injections and attend scheduled visits where healthcare professionals will monitor their progress, including assessments of eye symptoms like bulging and double vision, using the clinical activity score to measure disease activity. The medication is a monoclonal antibody that targets a specific protein involved in inflammation, aiming to reduce symptoms associated with thyroid eye disease.
Study on the Effects of Satralizumab for Patients with Moderate-to-Severe Thyroid Eye Disease
This trial evaluates Satralizumab, administered as a subcutaneous injection (120 mg dose), for treating moderate-to-severe thyroid eye disease. The study will run for 48 weeks, with participants receiving either Satralizumab or a placebo. The trial also involves other medications used to manage immune system activity and inflammation, including Azathioprine, Mycophenolate Mofetil, Tocilizumab, Rituximab, Ciclosporin, and Glucocorticoids.
Who can join: Adults 18 years or older with a clinical diagnosis of either active or chronic inactive thyroid eye disease. For active disease, participants must have a clinical activity score (CAS) of 3 or higher in the study eye, with symptoms that started within 12 months before the study. For chronic inactive disease, participants must have had stable disease with a CAS of less than 3 in both eyes for at least 6 months, with no new or worsening symptoms for at least 6 months, and an initial diagnosis made more than 12 months but less than 10 years before the study. All participants must have eye bulging (proptosis) of 3 mm or more above normal for their race and gender, along with at least one of the following: eyelid retraction of 2 mm or more, moderate or severe soft tissue involvement, or double vision that comes and goes or is constant. Thyroid function must be normal (euthyroid) or have mild hypothyroidism or hyperthyroidism that is under control.
Who cannot join: People with other serious eye conditions unrelated to thyroid eye disease, those who had recent eye surgery or are planning eye surgery during the study, individuals currently using certain medications that might interfere with the study treatment, people with a history of severe allergic reactions to similar medications, those with uncontrolled medical conditions, pregnant or breastfeeding women, people who participated in another clinical trial within a certain timeframe, individuals with a history of substance abuse, and those unable to comply with study procedures and follow-up visits.
Main focus: The study aims to evaluate how well Satralizumab reduces symptoms of thyroid eye disease, particularly focusing on improving eye bulging. Regular monitoring will track changes in proptosis and CAS throughout the study. At the end of the treatment period, researchers will assess the overall response to treatment, including quality of life related to visual functioning and appearance. The medication works by targeting and inhibiting a specific protein involved in the inflammatory process, helping to reduce symptoms associated with the disease.
Summary
The six ongoing clinical trials for Graves’ disease demonstrate a diverse range of therapeutic approaches currently under investigation. The trials are concentrated primarily in European countries, with Germany hosting the most studies (four trials), followed by Italy and Spain (three trials each). This geographical distribution reflects strong research activity in central and southern Europe.
Several investigational medications are being tested through injection-based delivery systems. IMVT-1402 and Batoclimab are both subcutaneous injections targeting immune system components to help normalize thyroid hormone levels. Rilzabrutinib represents an oral medication option, working by inhibiting Bruton’s tyrosine kinase (BTK) to reduce the autoimmune response. Two separate trials are evaluating Satralizumab, a monoclonal antibody administered subcutaneously, specifically for patients with moderate-to-severe thyroid eye disease.
Interestingly, one trial takes a different approach by comparing conventional medication (Tapazole) with more aggressive ablative treatments like radioiodine or thyroid surgery, particularly for patients who also have active eye involvement. This reflects ongoing questions in the medical community about optimal treatment strategies for complex cases.
The trials vary in duration from 24 to 52 weeks, with most focusing on achieving normal thyroid hormone levels while potentially reducing dependence on standard antithyroid medications. Several studies specifically address the challenging complication of Graves’ orbitopathy (eye disease), recognizing that eye symptoms significantly impact patients’ quality of life. All trials emphasize careful safety monitoring alongside effectiveness assessments, reflecting the experimental nature of these treatments.
