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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: argenx • ClinicalTrials.gov ID: NCT07570316

Registry updated: 2026-10-16
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Description

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

Interventions

  • Efgartigimod PH20 SC (Biological)
    Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)
  • Placebo PH20 SC (Other)
    Subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)

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.

Conditions

Graves' Disease Graves Disease

Locations

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

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record