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NCT07570316PHASE3Recruiting

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

argenx

Start Date

6/10/2026

Completion Date

5/1/2030

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

BIOLOGICAL

Efgartigimod PH20 SC

OTHER

Placebo PH20 SC

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Conditions

Graves' DiseaseGraves Disease

Locations

Diabetes Associates Medical Group

Orange, California 92868

United States

Havana Research Institute LLC.

Pasadena, California 91105

United States

Northeast Florida Endocrine & Diabetes Associates (NEFEDA) - Orange Park Location

Fleming Island, Florida 32003

United States

The Center for Diabetes and Endocrine Care

Fort Lauderdale, Florida 33312

United States

Ilumina Medical Research LLC

Kissimmee, Florida 34744

United States

Johnson County Clin-Trials, Inc.

Lenexa, Kansas 66219

United States

Metro Detroit Endocrinology Center

Dearborn, Michigan 48126

United States

Profound Research

Farmington Hills, Michigan 48334

United States

Endocrine Associates of West Village PC

New York, New York 10016

United States

Research Institute of Dallas

Dallas, Texas 75231

United States

Juno Research

Houston, Texas 77040

United States

Tekton Research Irving

Irving, Texas 75039

United States

Biopharma Informatic, LLC

McAllen, Texas 78503

United States

Tekton Research - McKinney

McKinney, Texas 75069

United States

Southern Endocrinology Associates PA

Mesquite, Texas 75149

United States

Consano Clinical Research

Shavano Park, Texas 78231

United States

New Hospitals

Tbilisi, 0114

Georgia

LLC Todua Clinic

Tbilisi, 0119

Georgia