Targeting the immune system: a new antibody may free Graves' patients from daily drugs
NCT ID NCT07722546
First seen Jul 23, 2026 · Last updated Sep 04, 2026 · Updated 5 times
Summary
This phase 2 trial tests whether felzartamab, an antibody that targets immune cells producing harmful antibodies, can restore normal thyroid function in people with Graves' disease. Participants will receive either felzartamab or a placebo alongside their usual anti-thyroid drugs, with the goal of eventually stopping those drugs. The study will measure how many people achieve normal thyroid levels without medication after 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental antibody drug called felzartamab
- What this could lead to
- If successful, felzartamab could offer a new treatment option for Graves' disease, potentially allowing patients to stop taking daily anti-thyroid drugs.
- What could go wrong
- This is an early phase 2 trial with only 60 participants. The drug may not work better than placebo, and side effects from targeting immune cells are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AME Clinical Research
RECRUITINGLos Angeles, California, 92647, United States
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Asheville Clinical Research
RECRUITINGAsheville, North Carolina, 28803, United States
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DM Clinical Research
RECRUITINGDoral, Florida, 33166, United States
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Floridian Clinical Research - Clinitiative
RECRUITINGMiami, Florida, 33016, United States
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M3 Wake Research - Dallas
RECRUITINGDallas, Texas, 75246, United States
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Solace Clinical Research - Puerto Rico
RECRUITINGBayamón, 00959, Puerto Rico
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Sun City Clinical Research
RECRUITINGGlendale, Arizona, 85304, United States
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