Recruiting

Phase 3

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

Sponsor:

argenx

Code:

NCT07570316

Conditions

Graves' Disease

Graves Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Efgartigimod PH20 SC

Placebo PH20 SC

Study Details

Brief 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

Conditions

Graves' Disease

Graves Disease

Study ID

NCT07570316

Start date

Jun 10, 2026

Status verified date

Aug, 2026

Completion date

May, 2030

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

230 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A - efgartigimod PH20 SC PFS

Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period.

placebo comparator: Part A - placebo PH20 SC PFS

Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period.

experimental: Part B - efgartigimod PH20 SC PFS

Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period.

experimental: Part B - placebo PH20 SC PFS

Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period.

experimental: Part C - efgartigimod PH20 SC PFS

Participants will receive efgartigimod PH20 SC PFS in the part C open-label treatment period

Interventions

Efgartigimod PH20 SC

Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)

Placebo PH20 SC

Subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)

Primary outcome measure

Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part A [ Time Frame: Up to 24 weeks (part A) ]

Central Contacts and Locations

Central contacts

Sabine Coppieters, MD

857-350-4834 clinicaltrials@argenx.com

Locations

Diabetes Associates Medical Group

Recruiting

Orange, California, United States, 92868

Contacts

Ivy-Joan Madu, MD

714-202-8894 diabetesmd@sbcglobal.net

Havana Research Institute LLC.

Recruiting

Pasadena, California, United States, 91105

Contacts

John De Beixedon, MD

626-698-9794 drjohn@havanaresearchinstitute.com

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

Recruiting

Fleming Island, Florida, United States, 32003

Contacts

Senan Sultan, MD

478-319-7900 drsultan@nerifl.com

The Center for Diabetes and Endocrine Care

Recruiting

Fort Lauderdale, Florida, United States, 33312

Contacts

Sam Lerman, MD

954-963-7100 slerman@diabetes-endocare.com

Ilumina Medical Research LLC

Recruiting

Kissimmee, Florida, United States, 34744

Contacts

Max Sosa-Pagan, MD

857-350-4834 MSosapaganMD@gmail.com

Johnson County Clin-Trials, Inc.

Recruiting

Lenexa, Kansas, United States, 66219

Contacts

Thomas Kreamer, MD

913-825-4400 tkreamer@jcct.com

Metro Detroit Endocrinology Center

Recruiting

Dearborn, Michigan, United States, 48126

Contacts

Ayman Elkadry, MD

313-203-5300 aymankad73@gmail.com

Profound Research

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Gary Edelson, MD

947-254-1920 gary.edelson@profoundresearch.io

Endocrine Associates of West Village PC

Recruiting

New York, New York, United States, 10016

Contacts

Anastasios Manessis, MD

646-660-9991 amanessis@endocrinenyc.com

Research Institute of Dallas

Recruiting

Dallas, Texas, United States, 75231

Contacts

Heidi Shea, MD

927-867-4658 hshea@eadallas.com

Juno Research

Recruiting

Houston, Texas, United States, 77040

Contacts

Damaris Vega, MD

713-779-5494 Dvega@jcct.com

Clinic of Endocrinology

Recruiting

Houston, Texas, United States, 77089

Contacts

Amir Hassan, MD

281-944-3610 amir@biopharmainfo.net

Tekton Research Irving

Recruiting

Irving, Texas, United States, 75039

Contacts

Pablo Mora, MD

972-566-7799 pablo.mora@tektonresearch.com

Biopharma Informatic, LLC

Recruiting

McAllen, Texas, United States, 78503

Contacts

Gloria Ortiz, MD

281-944-3610 gortiz@biopharmainfo.net

Tekton Research - McKinney

Recruiting

McKinney, Texas, United States, 75069

Contacts

Muhammad Siddiqui, MD

972-777-6011 muhammad.siddiqui@tektonresearch.com

Southern Endocrinology Associates PA

Recruiting

Mesquite, Texas, United States, 75149

Contacts

Sumana Gangi, MD

214-909-8904 sumana_gangi@yahoo.com

Consano Clinical Research

Recruiting

Shavano Park, Texas, United States, 78231

Contacts

Daniel Katselnik, MD

210-545-4900 katselnik.md@consanosa.com

More Information

Sponsor

argenx

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by argenx on 2026-08-12.