A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
argenx · NCT07570316
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 230
- US sites recruiting
- 27
- Study start
- June 10, 2026
- Record last updated
- October 16, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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
Being studied: Efgartigimod PH20 SC; Placebo PH20 SC
Conditions: Graves' Disease; Graves Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Diabetes Associates Medical Group
Orange, CA 92868
Site contact: Ivy-Joan Madu, MD · 714-202-8894 · diabetesmd@sbcglobal.net
Pasadena Clinical Trials
Pasadena, CA 91101
Site contact: Tzu-Jen Tzao · 5206127860 · ttzao@pasadenatrials.com
Havana Research Institute LLC.
Pasadena, CA 91105
Site contact: John De Beixedon, MD · 626-698-9794 · drjohn@havanaresearchinstitute.com
San Jose Clinical Trials
San Jose, CA 95128
Site contact: Richard Cherlin · 408-358-2663 · rcherlin@sanjosetrials.com
Northeast Florida Endocrine & Diabetes Associates (NEFEDA) - Orange Park Location
Fleming Island, FL 32003
Site contact: Senan Sultan, MD · 478-319-7900 · drsultan@nerifl.com
The Center for Diabetes and Endocrine Care
Fort Lauderdale, FL 33312
Site contact: Sam Lerman, MD · 954-963-7100 · slerman@diabetes-endocare.com
University of Florida Jacksonville College of Medicine
Jacksonville, FL 32256
Site contact: Christian Koch · +1 857-350-4834 · Christian.Koch@jax.ufl.edu
Ilumina Medical Research LLC
Kissimmee, FL 34744
Site contact: Max Sosa-Pagan, MD · 857-350-4834 · MSosapaganMD@gmail.com
Oceane 7 Medical & Research Center, Inc
Miami, FL 33144
Site contact: Orlando Fernandez · 305 261 2738 · o.fernandez.oceane7@gmail.com
Johnson County Clin-Trials, Inc.
Lenexa, KS 66219
Site contact: Thomas Kreamer, MD · 913-825-4400 · tkreamer@jcct.com
Alliance for Multispecialty Research, LLC
Wichita, KS 67226
Site contact: Terry Klein · 316-689-6629 · terry.klein@amr-clinical.com
University of Michigan
Ann Arbor, MI 48109
Site contact: Tae-Hwa Chun · 734-615-5420 · taehwa@med.umich.edu
Metro Detroit Endocrinology Center
Dearborn, MI 48126
Site contact: Ayman Elkadry, MD · 313-203-5300 · aymankad73@gmail.com
Profound Research
Farmington Hills, MI 48334
Site contact: Gary Edelson, MD · 947-254-1920 · gary.edelson@profoundresearch.io
Truman Medical Center
Kansas City, MO 64108
Site contact: Rajib Bhattacharya, MD · +1 857-350-4834 · rajib.bhattacharya@uhkc.org
Albany Medical College Community Endocrinology
Albany, NY 12203
Site contact: Robert Busch · 518 489 4704 · thyroiddoc@aol.com
Endocrine Associates of West Village PC
New York, NY 10016
Site contact: Anastasios Manessis, MD · 646-660-9991 · amanessis@endocrinenyc.com
Asheville Clinical Research
Asheville, NC 28803
Site contact: Lauren Bernstein · +1 857-350-4834 · bbernstein@ashevilleclinicaltrials.com
Research Institute of Dallas
Dallas, TX 75231
Site contact: Heidi Shea, MD · 927-867-4658 · hshea@eadallas.com
Frontier Medical Center - Academy of Diabetes Thyroid and Endocrine
El Paso, TX 79935
Site contact: Sergio Rovner · 915-633-9387 · sergiorovner@hotmail.com
Juno Research
Houston, TX 77040
Site contact: Damaris Vega, MD · 713-779-5494 · Dvega@jcct.com
Clinic of Endocrinology
Houston, TX 77089
Site contact: Amir Hassan, MD · 281-944-3610 · amir@biopharmainfo.net
Tekton Research Irving
Irving, TX 75039
Site contact: Pablo Mora, MD · 972-566-7799 · pablo.mora@tektonresearch.com
Biopharma Informatic, LLC
McAllen, TX 78503
Site contact: Gloria Ortiz, MD · 281-944-3610 · gortiz@biopharmainfo.net
Tekton Research - McKinney
McKinney, TX 75069
Site contact: Muhammad Siddiqui, MD · 972-777-6011 · muhammad.siddiqui@tektonresearch.com
Southern Endocrinology Associates PA
Mesquite, TX 75149
Site contact: Sumana Gangi, MD · 214-909-8904 · sumana_gangi@yahoo.com
Consano Clinical Research
Shavano Park, TX 78231
Site contact: Daniel Katselnik, MD · 210-545-4900 · katselnik.md@consanosa.com
Study contacts (from the official record)
- Sabine Coppieters, MD · 857-350-4834 · clinicaltrials@argenx.com