A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
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.
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
- Enrollment
- 230 participants
Conditions and interventions
Conditions
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 9, 2026
- Primary completion
- May 31, 2028
- Completion
- Apr 30, 2030
- Last update posted
- Aug 11, 2026
2026 – 2030
United States locations
- U.S. sites
- 17
- U.S. states
- 6
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Diabetes Associates Medical Group | Orange | California | 92868 | Recruiting |
| Havana Research Institute LLC. | Pasadena | California | 91105 | 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 |
| Ilumina Medical Research LLC | Kissimmee | Florida | 34744 | Recruiting |
| Johnson County Clin-Trials, Inc. | Lenexa | Kansas | 66219 | Recruiting |
| Metro Detroit Endocrinology Center | Dearborn | Michigan | 48126 | Recruiting |
| Profound Research | Farmington Hills | Michigan | 48334 | Recruiting |
| Endocrine Associates of West Village PC | New York | New York | 10016 | Recruiting |
| Research Institute of Dallas | Dallas | Texas | 75231 | 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 Aug 11, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07570316 live on ClinicalTrials.gov.