A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
Key facts
- Where
- Albany, Ann Arbor, Asheville, Carlsbad, Dallas, Dearborn, El Paso, Farmington Hills, Fleming Island, Fort Lauderdale, Houston, Irving, Jacksonville, Kansas City, Kissimmee, Lenexa, McAllen, McKinney, Mesquite, Miami, New York, Orange, Pasadena, Raleigh, San Jose, Shavano Park, and Wichita, United StatesSee the 29 sites
- Phase
- Phase 3
Where in United States
- Albany Medical College Community EndocrinologyAlbany, United StatesContact: Robert BuschTaking people
- University of MichiganAnn Arbor, United StatesContact: Tae-Hwa ChunTaking people
- Asheville Clinical ResearchAsheville, United StatesContact: Lauren BernsteinTaking people
- Profound Research LLC at Tri-City Primary CareCarlsbad, United StatesContact: Jamil Alkhaddo, MDTaking people
- Research Institute Of DallasDallas, United StatesContact: Heidi Shea, MDTaking people
- Metro Detroit Endocrinology CenterDearborn, United StatesContact: Ayman Elkadry, MDTaking people
- Frontier Medical Center - Academy of Diabetes Thyroid and EndocrineEl Paso, United StatesContact: Sergio RovnerTaking people
- Profound ResearchFarmington Hills, United StatesContact: Gary Edelson, MDTaking people
- Northeast Florida Endocrine & Diabetes Associates (NEFEDA) - Orange Park LocationFleming Island, United StatesContact: Senan Sultan, MDTaking people
- The Center for Diabetes and Endocrine CareFort Lauderdale, United StatesContact: Sam Lerman, MDTaking people
- Clinic of EndocrinologyHouston, United StatesContact: Amir Hassan, MDTaking people
- Juno ResearchHouston, United StatesContact: Damaris Vega, MDTaking people
- Tekton Research IrvingIrving, United StatesContact: Pablo Mora, MDTaking people
- University of Florida Jacksonville College of MedicineJacksonville, United StatesContact: Christian KochTaking people
- Truman Medical CenterKansas City, United StatesContact: Rajib Bhattacharya, MDTaking people
- Ilumina Medical Research LLCKissimmee, United StatesContact: Max Sosa-Pagan, MDTaking people
- Johnson County Clin-Trials, Inc.Lenexa, United StatesContact: Thomas Kreamer, MDTaking people
- Biopharma Informatic, LLCMcAllen, United StatesContact: Gloria Ortiz, MDTaking people
- Tekton Research - McKinneyMcKinney, United StatesContact: Muhammad Siddiqui, MDTaking people
- Southern Endocrinology Associates PAMesquite, United StatesContact: Sumana Gangi, MDTaking people
- Oceane 7 Medical & Research Center, Inc.Miami, United StatesContact: Orlando FernandezTaking people
- Endocrine Associates of West Village PCNew York, United StatesContact: Anastasios Manessis, MDTaking people
- Diabetes Associates Medical GroupOrange, United StatesContact: Ivy-Joan Madu, MDTaking people
- Havana Research Institute LLCPasadena, United StatesContact: John De Beixedon, MDTaking people
- Pasadena Clinical TrialsPasadena, United StatesContact: Tzu-Jen TzaoTaking people
- Wake Internal Medicine ConsultantsRaleigh, United StatesContact: Juman Takeddin, MDTaking people
- San Jose Clinical TrialsSan Jose, United StatesContact: Richard CherlinTaking people
- Consano Clinical ResearchShavano Park, United StatesContact: Daniel Katselnik, MDTaking people
- Alliance for Multispecialty Research LLCWichita, United StatesContact: Terry KleinTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- argenx
- Trial code
- NCT07570316EU 2025-524223-42-00
- Record updated
- 3 November 2026
- Original 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.Read full original descriptionShow less
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
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
Inclusion: 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: 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; History of hyperthyroidism not caused by GD (eg, toxic adenoma or toxic multinodular goiter); 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.