Miami, FLNCT07722546Now EnrollingIRB Ready

Graves' Disease Clinical Trial in Miami, FL

Access cutting-edge graves' disease treatment through this phase 2 clinical trial at a research site in Miami. Study-provided care at no cost to qualified participants.

Sponsored by Biogen

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Expert Care in Miami

Access graves' disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related graves' disease treatment provided free

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Check if you qualify for this graves' disease clinical trial in Miami, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Miami

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Miami site if eligible
  4. 4Begin participation

About This Graves' Disease Study in Miami

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. Participants will receive either felzartamab or placebo during the study. A placebo looks like the study drug but contains no real medicine. The main question that researchers want to answer is: • How many participants have normal thyroid levels without receiving any ATD medicine at Week 24? Researchers will also learn more about the safety of felzartamab and how the body processes the drug. The study will be done as follows: * Participants will be screened to check if they can join the study. * This is a double-blind study, which means neither the participants, study doctor, or site staff will know if participants are receiving felzartamab or a placebo. * Participants will be placed into 1 of 3 groups. Two groups will receive felzartamab while the other receives placebo. * Participants will receive felzartamab or placebo as intravenous (IV) infusions, which are slow injections into a vein using a needle. The Treatment Period will last 20 weeks. * During the Treatment Period, the study doctor may gradually lower the dose of the ATD if a participant's thyroid levels become normal. * Afterwards, participants will enter a follow-up period which will last 12 weeks. * In total, participants will have 22 study visits. Participants will stay in the study for about 9 months (up to 36 weeks).

Sponsor: Biogen

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami?

Yes, this clinical trial (NCT07722546) has an active research site in Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Graves' Disease Treatment Options in Miami, FL

If you're searching for graves' disease treatment options in Miami, FL, this clinical trial (NCT07722546) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced graves' disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all graves' disease clinical trials near you to find additional studies recruiting in your area.

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