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

ClinicalTrials.gov ID: NCT07570316

Public ClinicalTrials.gov record NCT07570316. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 22, 2026, 5:37 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT07570316
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: argenx; Industry
Enrollment: 230 participants

Conditions and interventions

Conditions

Interventions

Efgartigimod PH20 SC Biological
Placebo PH20 SC Other

Biological · Other

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 10, 2026 (Actual)
Primary completion: Jun 2028 (Estimated)
Completion: May 2030 (Estimated)
Last update posted: Oct 16, 2026

2026 – 2030

United States locations

U.S. sites: 27
U.S. states: 8
U.S. cities: 25

Facility	City	State	ZIP	Site status
Diabetes Associates Medical Group	Orange	California	92868	Recruiting
Pasadena Clinical Trials	Pasadena	California	91101	Recruiting
Havana Research Institute LLC.	Pasadena	California	91105	Recruiting
San Jose Clinical Trials	San Jose	California	95128	Recruiting
Northeast Florida Endocrine & Diabetes Associates (NEFEDA) - Orange Park Location	Fleming Island	Florida	32003	Recruiting
The Center for Diabetes and Endocrine Care	Fort Lauderdale	Florida	33312	Recruiting
University of Florida Jacksonville College of Medicine	Jacksonville	Florida	32256	Recruiting
Ilumina Medical Research LLC	Kissimmee	Florida	34744	Recruiting
Oceane 7 Medical & Research Center, Inc	Miami	Florida	33144	Recruiting
Johnson County Clin-Trials, Inc.	Lenexa	Kansas	66219	Recruiting
Alliance for Multispecialty Research, LLC	Wichita	Kansas	67226	Recruiting
University of Michigan	Ann Arbor	Michigan	48109	Recruiting
Metro Detroit Endocrinology Center	Dearborn	Michigan	48126	Recruiting
Profound Research	Farmington Hills	Michigan	48334	Recruiting
Truman Medical Center	Kansas City	Missouri	64108	Recruiting
Albany Medical College Community Endocrinology	Albany	New York	12203	Recruiting
Endocrine Associates of West Village PC	New York	New York	10016	Recruiting
Asheville Clinical Research	Asheville	North Carolina	28803	Recruiting
Research Institute of Dallas	Dallas	Texas	75231	Recruiting
Frontier Medical Center - Academy of Diabetes Thyroid and Endocrine	El Paso	Texas	79935	Recruiting
Juno Research	Houston	Texas	77040	Recruiting
Clinic of Endocrinology	Houston	Texas	77089	Recruiting
Tekton Research Irving	Irving	Texas	75039	Recruiting
Biopharma Informatic, LLC	McAllen	Texas	78503	Recruiting
Tekton Research - McKinney	McKinney	Texas	75069	Recruiting
Southern Endocrinology Associates PA	Mesquite	Texas	75149	Recruiting
Consano Clinical Research	Shavano Park	Texas	78231	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07570316, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 16, 2026 · Synced Oct 22, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07570316 live on ClinicalTrials.gov.

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