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A Study of Efgartigimod for Graves' Disease

This study is investigating efgartigimod PH20 SC, given as an injection, for adults with Graves' Disease (an autoimmune condition causing an overactive thyroid). Researchers want to see if efgartigimod can help bring your thyroid hormone levels (fT3, fT4, and TSH) back to normal ranges, allowing you to stop taking anti-thyroid drugs (ATDs). They will also check how safe efgartigimod is and how well your body tolerates it. To join, you must be at least 18 years old, have a confirmed diagnosis of Graves' Disease with specific antibody levels (TRAb), and have an overactive thyroid (TSH <0.1 mIU/L). The study aims to enroll 230 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 230 participants. It includes a double-blinded period where you might receive efgartigimod PH20 SC or a placebo (an inactive substance), followed by open-label treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at up to 24 weeks (part A) to see if participants are euthyroid (normal thyroid function) off ATDs.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07570316

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease

Recruiting
PHASE3Ages 18+InterventionalTreatment
argenx
~230 participants
Updated 2026-09-17 on ClinicalTrials.gov
What's tested:Efgartigimod PH20 SCPlacebo PH20 SC

At a glance

Recruiting sites
22 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part A
Measured over Up to 24 weeks (part A)

Conditions

Graves' Disease
Graves Disease

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NCT07570316

Where you'd take part

This study runs at 23 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Biopharma Informatic, LLC

    McAllen, Texasstudy coordinator listed

    Recruiting

  • Clinic of Endocrinology

    Houston, Texasstudy coordinator listed

    Recruiting

  • Consano Clinical Research

    Shavano Park, Texasstudy coordinator listed

    Recruiting

  • Diabetes Associates Medical Group

    Orange, Californiastudy coordinator listed

    Recruiting

  • Endocrine Associates of West Village PC

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Havana Research Institute LLC.

    Pasadena, Californiastudy coordinator listed

    Recruiting

  • Ilumina Medical Research LLC

    Kissimmee, Floridastudy coordinator listed

    Recruiting

  • In Vitro Fertilization Center LLC

    Tbilisi, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Sabine Coppieters, MD
[email protected]
857-350-4834
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part AUp to 24 weeks (part A)

    Free triiodothyronine: \[fT3\]; free thyroxine: \[fT4\]; ATDs: antithyroid drugs