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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Graves' Disease, Graves Disease

In brief

The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated. It will look at how efgartigimod is distributed and eliminated in the body, how it changes antibody levels, and how the immune system responds to it. The study consists of a part A double-blinded treatment period, a part B treatment/observation period and a part C open-label treatment/observation period. During the part A and part B treatment periods, participants will receive efgartigimod PH20 SC via Prefilled Syringe (PFS) or placebo. During the part C open-label treatment period, participants will receive efgartigimod PH20 SC PFS. Participation in the different parts of the study will depend on the participant's response to treatment. The total study duration for participants ranges from 63 to 135 weeks, depending on the response to treatment. More information can be found here: https://clinicaltrials.argenx.com/vitalithy

Key facts

Study ID

NCT07570316

Run by

argenx

People needed

230

Starts

2026-06-10

Expected to finish

2030-05-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Diabetes Associates Medical Group — Orange, California, United States (enrolling)
• Havana Research Institute LLC. — Pasadena, California, United States (enrolling)
• Northeast Florida Endocrine & Diabetes Associates (NEFEDA) - Orange Park Location — Fleming Island, Florida, United States (enrolling)
• The Center for Diabetes and Endocrine Care — Fort Lauderdale, Florida, United States (enrolling)
• Ilumina Medical Research LLC — Kissimmee, Florida, United States (enrolling)
• Johnson County Clin-Trials, Inc. — Lenexa, Kansas, United States (enrolling)
• Metro Detroit Endocrinology Center — Dearborn, Michigan, United States (enrolling)
• Profound Research — Farmington Hills, Michigan, United States (enrolling)
• Endocrine Associates of West Village PC — New York, New York, United States (enrolling)
• Research Institute of Dallas — Dallas, Texas, United States (enrolling)
• Juno Research — Houston, Texas, United States (enrolling)
• Tekton Research Irving — Irving, Texas, United States (enrolling)
• Biopharma Informatic, LLC — McAllen, Texas, United States (enrolling)
• Tekton Research - McKinney — McKinney, Texas, United States (enrolling)
• Southern Endocrinology Associates PA — Mesquite, Texas, United States (enrolling)
• Consano Clinical Research — Shavano Park, Texas, United States (enrolling)
• New Hospitals — Tbilisi, Georgia (enrolling)
• LLC Todua Clinic — Tbilisi, Georgia (enrolling)

Full record on ClinicalTrials.gov

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