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

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

NCT07596849

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

• High Technology Hospital Medcenter LLC — Batumi, Georgia (enrolling)
• First Medical Clinic Ltd — Tbilisi, Georgia (enrolling)
• LTD MediClub Georgia — Tbilisi, Georgia (enrolling)
• Aso Iizuka Hospital — Iizuka, Japan (enrolling)
• National Hospital Organization Kyoto Medical Center — Kyoto, Japan (enrolling)
• SHOWA Medical University Northern Yokohama Hospital — Yokohama, Japan (enrolling)
• Tottori University Hospital — Yonago, Japan (enrolling)

Full record on ClinicalTrials.gov

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