Efgartigimod for Graves' Disease in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional study in adults with Graves' disease to see how efgartigimod PH20 SC affects thyroid function and immune responses. The trial includes a double-blind portion comparing efgartigimod to placebo, followed by treatment/observation and then an open-label phase where all participants may receive the drug. The study will evaluate pharmacokinetics, antibody changes, and safety outcomes over 63 to 135 weeks depending on response. Participation depends on response and eligibility criteria related to GD activity and prior treatment; site visits occur at multiple U.S. centers. Primary sponsor is argenx, with several clinical sites coordinating enrollment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Profound Research LLC at Tri-City Primary Care
  Carlsbad, California, United States Recruiting
• Diabetes Associates Medical Group
  Orange, California, United States Recruiting
• Pasadena Clinical Trials
  Pasadena, California, United States Recruiting
• Havana Research Institute LLC.
  Pasadena, California, United States Recruiting
• San Jose Clinical Trials
  San Jose, California, United States Recruiting
• Northeast Florida Endocrine & Diabetes Associates (NEFEDA) - Orange Park Location
  Fleming Island, Florida, United States Recruiting

Study contacts

• Study coordinator: Sabine Coppieters, MD
• Email: clinicaltrials@argenx.com
• Phone: 857-350-4834

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.