About this trial
This study will test an experimental Regeneron drug called REGN24493 hereby referred to as "study drug" to see if it can help treat Graves' disease. Graves' disease is a condition where the immune system causes the thyroid gland to make too much thyroid hormone.
The main purpose of this study is to learn about the safety of REGN24493 and what side effects it might cause.
The study is looking at:
* What side effects REGN24493 might cause * How much REGN24493 is in the blood at different times * How REGN24493 affects thyroid hormone levels * If the body reacts to REGN24493 in a way that could affect participant's health * What is the best dose of REGN24493 for treating Graves' disease
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has a diagnosis of Graves' Disease for at least 4 months prior to the screening visit
Has thyroid-stimulating hormone receptor antibody (TRAb) level above the upper limit of normal at the screening visit
Euthyroid at the screening visit and at least 4 weeks prior to the screening visit as defined in the protocol
Body mass index (BMI) between 18.5 and 35.0 kg/m² (inclusive) at the screen visit
Disqualifiers
Has history of hyperthyroidism not caused by Graves' disease (eg, toxic thyroid adenoma, multinodular goiter, amiodarone-induced)
Has active thyroid storm or is at current risk of thyroid storm, as assessed by the investigator at the screening visit
Has clinically significant cardiac abnormalities attributable to uncontrolled Graves' disease (eg, arrhythmias precipitated by thyrotoxicosis, thyrotoxic cardiomyopathy)
Has any infection requiring systemic therapy within the 4 weeks prior to the screening visit
Trial design
Sequential
Treatments tested in this trial
REGN24493
DrugAdministered per the protocol.
Placebo
DrugAdministered per the protocol.
Treatment groups
Trial outcomes
Primary outcomes
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Secondary outcomes
Concentrations of REGN24493 in serum
Serum Thyroid-Stimulating Hormone (TSH) levels
Serum free T4 (fT4) levels
Serum free T3 (fT3) levels
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: