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A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old

RecruitingPhase 2Ages 18 Years - 75 YearsAllBiogen
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In plain words

What the trial is, and whether it could suit you

In this study, researchers will learn more about the use of felzartamab in participants with Graves' Disease, also known as GD. GD is an autoimmune disease, which means the body's immune system attacks its own healthy cells. In people with GD, the immune system produces abnormal antibodies, called thyroid-stimulating hormone receptor antibodies (TRAb), that attack the thyroid gland. This causes the thyroid to become too active and produce too much hormone, a condition called hyperthyroidism. Participants with GD are often treated with anti-thyroid drugs, or ATDs, which are medicines that help bring thyroid hormone levels back to normal. Felzartamab is designed to target certain immune cells that produce the abnormal TRAb antibodies. The main goal of the study is to learn whether felzartamab can help bring thyroid hormone levels back to normal and allow participants to stop taking ATDs.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: * Have active disease and are thyroid-stimulating hormone receptor antibodies (TRAb) positive, defined as: * Free thyroxine (FT4) and free triiodothyronine (FT3), within the reference range, * suppressed thyroid-stimulating hormone (TSH) * TRAb levels \> upper limit of normal (ULN) * Participants must be receiving stable dose of anti-thyroid drugs (ATD) for at least 12 weeks prior to randomization. * Must agree to refrain from blood product donation from Screening through end of study. If a participant terminates early from the study, they must refrain from blood product donation for 90 days following the last dose of study drug. Key Exclusion Criteria: * History of thyroidectomy or radioactive iodine therapy. * ATD dose change within 12 weeks prior to Day1, or anticipated need for dose adjustment prior to randomization (except for protocol-defined safety management). * Active, moderate-to-severe, or sight threatening thyroid eye disease (TED) (as assessed by the clinical activity score \[CAS\]), or requirement for imminent or ongoing TED-directed therapy (e.g., systemic glucocorticoids, biologic therapy, orbital radiation, surgery). * Any history of malignancy within 5 years prior to Screening except for adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer. * History of hyperthyroidism not caused by GD (e.g. toxic multinodular goiter, autonomous thyroid nodule, acute inflammatory thyroiditis) and/or history or presence of thyroid storm. * Type 1 diabetes and type 2 diabetes mellitus with hemoglobin A1c (HbA1c) \> 8%. * Known or suspected history of hypersensitivity to felzartamab or its excipients. * Use of immunosuppressive therapy within 5 half-lives/12 weeks of Screening. * Co-existing autoimmune diseases that require systemic immunosuppressants (e.g., cyclosporine, methotrexate, biologics, monoclonals). * Prior use of an anti-Neonatal Fragment Crystallizable Receptor (FcRn) therapy or intravenous immunoglobulin (IVIg) within 6 months of the last dose prior to Screening. * Any condition that requires chronic use of high-dose steroids. NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
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What it tests

  • Felzartamab
  • Placebo
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Where

14 sites
Sun City Clinical Research
Glendale, United States
AME Clinical Research
Los Angeles, United States
San Jose Clinical Trials
San Jose, United States
DM Clinical Research
Doral, United States
Floridian Clinical Research - Clinitiative
Miami, United States
Bioluminux Clinical Research
Naperville, United States
Patient First Clinical Trials (PFCTrials)
Lutherville, United States
Bioluminux Clinical Research
Hamilton, United States

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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