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New shot could help tame stubborn Graves' disease

NCT ID NCT07570316

Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 6 times

Summary

This study tests a drug called efgartigimod, given as a shot under the skin, for adults with Graves' disease whose thyroid levels are still too high despite taking standard antithyroid drugs. About 230 people will take part, and some will get the drug while others get a placebo. The goal is to see if efgartigimod can help bring thyroid hormone levels back to normal without needing other medications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
efgartigimod
What this could lead to
If it works, this could offer a new treatment option for people with Graves' disease whose thyroid levels are not well controlled with standard antithyroid drugs.
What could go wrong
This is an early Phase 3 trial, so results are not yet known. The drug may not work better than placebo, and side effects are possible. It is not a cure, and patients may still need ongoing medication.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 230 people

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

Started

Jun 2026

Expected to finish

May 2030

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 years and older

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.

Inclusion Criteria: * Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF. * Has a documented diagnosis of GD with TRAb (anti-thyrotropin receptor antibody) levels \>=ULN (upper limit of normal) at screening. * Has active hyperthyroidism due to GD with TSH (thyroid-stimulating hormone) \<0.1 mIU/L at screening. * Has been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 months before screening. Exclusion Criteria: * History of hyperthyroidism not caused by GD (eg, toxic adenoma or toxic multinodular goiter). * History of RAI (radioactive iodine) therapy or received a total thyroidectomy. * T3- or T4-containing medication or supplement (eg, levothyroxine, liothyronine, desiccated thyroid preparations, or thyroid-support supplements) received \<6 weeks before screening. * Any complication of hyperthyroidism or underlying medical condition that would put the participant at undue risk. This includes arrhythmia or tachyarrhythmia related to GD, such as atrial fibrillation or atrial flutter not sufficiently controlled with medications. * Graves' orbitopathy/Thyroid Eye Disease (GO/TED) requiring systemic therapy (eg, corticosteroids), orbital injections, orbital surgery, or orbital radiation, or expected immediate surgical intervention and/or planned corrective surgery/irradiation or medical therapy during the study.

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Conditions

The condition(s) this trial relates to.

Graves disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graves disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Biopharma Informatic, LLC

    RECRUITING

    McAllen, Texas, 78503, United States

  • Clinic of Endocrinology

    RECRUITING

    Houston, Texas, 77089, United States

  • Consano Clinical Research

    RECRUITING

    Shavano Park, Texas, 78231, United States

  • Diabetes Associates Medical Group

    RECRUITING

    Orange, California, 92868, United States

  • Endocrine Associates of West Village PC

    RECRUITING

    New York, New York, 10016, United States

  • Havana Research Institute LLC.

    RECRUITING

    Pasadena, California, 91105, United States

  • Ilumina Medical Research LLC

    RECRUITING

    Kissimmee, Florida, 34744, United States

  • In Vitro Fertilization Center LLC

    RECRUITING

    Tbilisi, 0159, Georgia

  • Johnson County Clin-Trials, Inc.

    RECRUITING

    Lenexa, Kansas, 66219, United States

  • Juno Research

    RECRUITING

    Houston, Texas, 77040, United States

  • LLC American Hospital Network

    RECRUITING

    Tbilisi, 0102, Georgia

  • LLC Todua Clinic

    RECRUITING

    Tbilisi, 0119, Georgia

  • LTD Israeli-Georgian Medical Research Clinic Healthycore

    RECRUITING

    Tbilisi, 0112, Georgia

  • Metro Detroit Endocrinology Center

    RECRUITING

    Dearborn, Michigan, 48126, United States

  • New Hospitals

    RECRUITING

    Tbilisi, 0114, Georgia

  • Northeast Florida Endocrine & Diabetes Associates (NEFEDA) - Orange Park Location

    RECRUITING

    Fleming Island, Florida, 32003, United States

  • Profound Research

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Research Institute of Dallas

    RECRUITING

    Dallas, Texas, 75231, United States

  • Southern Endocrinology Associates PA

    RECRUITING

    Mesquite, Texas, 75149, United States

  • Tekton Research - McKinney

    RECRUITING

    McKinney, Texas, 75069, United States

  • Tekton Research Irving

    RECRUITING

    Irving, Texas, 75039, United States

  • The Center for Diabetes and Endocrine Care

    RECRUITING

    Fort Lauderdale, Florida, 33312, United States

  • Truman Medical Center

    ACTIVE_NOT_RECRUITING

    Kansas City, Missouri, 64108, United States

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