Graves' disease is the most common cause of hyperthyroidism, driven by autoantibodies that stimulate the thyroid-stimulating hormone receptor, causing the thyroid to overproduce thyroid hormones. It also affects the eyes in a subset of patients (Graves' orbitopathy), causing proptosis, double vision, and occasionally vision-threatening complications.
What's actually going on in research
Standard treatment options — antithyroid drugs, radioactive iodine, and surgery — control hormone levels but do not target the underlying autoimmune cause, and relapse rates after stopping antithyroid drugs are high. Teprotumumab is now approved for Graves' orbitopathy. Disease-modifying trials are testing drugs that deplete or modulate the B cells producing TSH receptor antibodies, aiming for durable remission. IGF-1 receptor inhibitors and FcRn blockers that accelerate antibody clearance are also in trials.
FcRn blocker therapy
FcRn receptor blockers such as batoclimab and rozanolixizumab accelerate breakdown of disease-causing TSH receptor antibodies, offering a potential path to remission by reducing the antibody driving hyperthyroidism.
B cell depletion
Rituximab and newer anti-CD20 and anti-CD19 monoclonal antibodies are being tested in Graves' disease to deplete the B cells that produce TSH receptor antibodies and induce longer-lasting remission.
Orbitopathy management
Teprotumumab, an IGF-1 receptor inhibitor, is approved for active Graves' orbitopathy; trials are studying repeat courses, combination with steroids, and treatment of chronic inactive orbitopathy.
What to know before you search
Eligibility depends on TSH receptor antibody levels, thyroid hormone levels, presence and severity of orbitopathy, and prior treatment history.
What types of trials are currently open
- TSH receptor antibody reduction trials — Testing FcRn blockers and B cell-depleting drugs to eliminate the autoantibodies driving hyperthyroidism.
- Orbitopathy trials — Evaluating teprotumumab and combination therapies for eye disease associated with Graves' disease.
- Antithyroid drug trials — Studying extended or weight-based dosing strategies to increase remission rates.
- Comparative treatment trials — Comparing outcomes, quality of life, and relapse rates between radioactive iodine, surgery, and medical therapy.
- Remission biomarker trials — Identifying TSH receptor antibody levels and other markers that predict which patients can safely stop treatment.
Recently added Graves' Disease trials
Take an experimental therapy for thyroid eye disease
The purpose of this study is to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with thyroid eye disease (TED).
Take an oral medication to treat severe thyroid-related eye disease
Thyroid Eye Disease (TED), also known as Graves' orbitopathy, is an autoimmune condition that causes inflammation and tissue expansion behind the eyes, leading to bulging eyes (proptosis), double vision, and pain. Currently, intravenous glucocorticoids (steroids) are the standard first-line treatment. However, approximately 20-30% of patients do not respond to steroids, or cannot tolerate their side effects. This study aims to evaluate the safety and efficacy of Tofacitinib, an oral medication known as a Janus kinase (JAK) inhibitor, as a rescue therapy for these difficult-to-treat cases. Tofacitinib works by blocking specific signaling pathways (JAK-STAT) that drive inflammation and fibrosis in the eye socket. In this study, patients with moderate-to-severe active TED who are resistant to or intolerant of steroids will receive Tofacitinib tablets (5 mg twice daily) for 24 weeks. The researchers will assess whether the treatment can effectively reduce eye bulging and improve clinical activity scores.
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