NCT07570316From ClinicalTrials.govRecruiting

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

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease Inadequately Controlled With Antithyroid Drugs

Graves' Disease
Graves Disease

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: argenx
Enrolment target: 230
Started: 10 June 2026
Main results due: June 2028
Study sites: 26
Registry updated: 24 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(26)

Diabetes Associates Medical Group
Orange, California, United States
Recruiting
Havana Research Institute LLC.
Pasadena, California, United States
Recruiting
Northeast Florida Endocrine & Diabetes Associates (NEFEDA) - Orange Park Location
Fleming Island, Florida, United States
Recruiting
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, United States
Recruiting
University of Florida Jacksonville College of Medicine
Jacksonville, Florida, United States
Recruiting
Ilumina Medical Research LLC
Kissimmee, Florida, United States
Recruiting
Oceane 7 Medical & Research Center, Inc
Miami, Florida, United States
Recruiting
Johnson County Clin-Trials, Inc.
Lenexa, Kansas, United States
Recruiting
Metro Detroit Endocrinology Center
Dearborn, Michigan, United States
Recruiting
Profound Research
Farmington Hills, Michigan, United States
Recruiting
Truman Medical Center
Kansas City, Missouri, United States
Recruiting
Albany Medical College Community Endocrinology
Albany, New York, United States
Recruiting
Endocrine Associates of West Village PC
New York, New York, United States
Recruiting
Research Institute of Dallas
Dallas, Texas, United States
Recruiting
Juno Research
Houston, Texas, United States
Recruiting
Clinic of Endocrinology
Houston, Texas, United States
Recruiting
Tekton Research Irving
Irving, Texas, United States
Recruiting
Biopharma Informatic, LLC
McAllen, Texas, United States
Recruiting
Tekton Research - McKinney
McKinney, Texas, United States
Recruiting
Southern Endocrinology Associates PA
Mesquite, Texas, United States
Recruiting
Consano Clinical Research
Shavano Park, Texas, United States
Recruiting
LLC American Hospital Network
Tbilisi, Georgia
Recruiting
LTD Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia
Recruiting
New Hospitals
Tbilisi, Georgia
Recruiting
LLC Todua Clinic
Tbilisi, Georgia
Recruiting
In Vitro Fertilization Center LLC
Tbilisi, Georgia
Recruiting

Showing 26 of 26 sites. 26 of the 26 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07570316. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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