Targeting the immune system: a new antibody may free Graves' patients from daily drugs

NCT ID NCT07722546

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    7 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • AME Clinical Research

    RECRUITING

    Los Angeles, California, 92647, United States

  • Asheville Clinical Research

    RECRUITING

    Asheville, North Carolina, 28803, United States

  • DM Clinical Research

    RECRUITING

    Doral, Florida, 33166, United States

  • Floridian Clinical Research - Clinitiative

    RECRUITING

    Miami, Florida, 33016, United States

  • M3 Wake Research - Dallas

    RECRUITING

    Dallas, Texas, 75246, United States

  • Solace Clinical Research - Puerto Rico

    RECRUITING

    Bayamón, 00959, Puerto Rico

  • Sun City Clinical Research

    RECRUITING

    Glendale, Arizona, 85304, United States

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