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 Phase 3 interventional study evaluates efgartigimod PH20 SC (with a placebo control in parts of the study) in adults with Graves’ disease. It uses a multi-part design: a double-blind treatment period, a treatment/observation period, and an open-label period to assess safety, pharmacokinetics, antibody changes, and immune response. Participants may receive either the active drug or placebo during the initial phases, and all may receive the drug during the open-label phase, depending on response. The trial aims to determine how the drug distributes and clears in the body and its effect on thyroid-related markers over a follow-up ranging from roughly 63 to 135 weeks.

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

• AZORG Ziekenhuis
  Aalst, Oost-Vlass, Belgium Recruiting
• Universitair Ziekenhuis Gent
  Ghent, Belgium Recruiting
• Medical Center Tonus - 2013 OOD
  Pazardzhik, Bulgaria Recruiting
• DCC Pulmed
  Plovdiv, Bulgaria Recruiting
• Multiprofile Hospital for Active Treatment Hadzhi Dimitar OOD
  Sliven, Bulgaria Recruiting
• Medical Center Kalimat
  Sofia, Bulgaria Recruiting

+1 more sites. See ClinicalTrials.gov for the full list.

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.

• Efgartigimod for Graves' Disease in adults

  We are testing if efgartigimod given under the skin can help adults with Graves' disease by improving thyroid function and whether it is safe and tolerable.

  Recruiting at 35 sites Phase 3 argenx · Carlsbad, California and 34 other locations · NCT07570316

• ETHY-001 safety and activity in Thyroid Eye Disease (TED)

  This study tests ETHY-001 versus placebo to see if it is safe, tolerable, and shows activity in people with thyroid eye disease.

  Recruiting at 2 sites Phase 1 Ethyreal Bio, Inc. · Orland Park, Illinois and 2 other locations · NCT07885605

• Early risk stratification of thyroid eye disease in newly diagnosed Graves' disease

  This study tests whether early eye-related signs, blood and tear biomarkers, or eye surface features can predict who with Graves’ disease will develop thyroid eye disease within a year.

  Recruiting University of Copenhagen · Herlev · NCT07812194

• Felzartamab for Graves’ Disease: See if it helps control thyroids and reduce need for ATDs

  This study tests felzartamab vs placebo in adults with Graves’ disease to see if it can normalize thyroid hormones and let people stop anti-thyroid drugs.

  Recruiting at 14 sites Phase 2 Biogen · Glendale, Arizona and 13 other locations · NCT07722546

• AI-based MRI and ultrasound for thyroid-related eye disease

  This study tests an AI model using orbital MRI and eye ultrasound to help diagnose activity and severity of thyroid-associated ophthalmopathy and predict its course in adults.

  Recruiting Shanghai Changzheng Hospital · Shanghai, Huangpu District · NCT07716397

• YB-101 for Graves' Disease: safety, dosing, and how it works

  This study tests YB-101 versus placebo in adults with Graves' disease to see if it is safe, tolerated, and whether it can help thyroid symptoms over about 40 weeks.

  Recruiting at 25 sites Phase 2 Yarrow Bioscience, Inc. · Gilbert, Arizona and 31 other locations · NCT07682896

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.