A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
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
- Graves Disease
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- argenx
- Enrolment target
- 230
- Started
- 10 June 2026
- Main results due
- June 2028
- Study sites
- 29
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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
What this study is about
In the sponsor’s own words, from the registry.
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 sites(29)
Medical Center Tonus - 2013 OOD
Pazardzhik, Bulgaria
Recruiting
Multiprofile Hospital for Active Treatment Hadzhi Dimitar OOD
Sliven, Bulgaria
Recruiting
Diagnostic Consultative Center Ekvita OOD
Varna, Bulgaria
Recruiting
MC Klinika Nova
Varna, Bulgaria
Recruiting
Multi-Profile District Hospital for Active Treatment Dr. Stefan Cherkezov
Veliko Tarnovo, Bulgaria
Recruiting
Endocrinologie Oasis
Montreal, Quebec, Canada
Recruiting
TLC Diabetes and Endocrinology Clinic
Surrey, Canada
Recruiting
High Technology Hospital Medcenter LLC
Batumi, Georgia
Recruiting
First Medical Clinic Ltd
Tbilisi, Georgia
Recruiting
LTD MediClub Georgia
Tbilisi, Georgia
Recruiting
Juntendo University Hospital
Bunkyō-Ku, Tokyo, Japan
Recruiting
Toho University Omori Medical Center
Ōta-ku, Tokyo, Japan
Recruiting
Aso Iizuka Hospital
Iizuka, Japan
Recruiting
Nippon Medical School Musashikosugi Hospital
Kawasaki, Japan
Recruiting
Hospital of University of Occupational and Environmental Health
Kitakyushu, Japan
Recruiting
National Hospital Organization Kyoto Medical Center
Kyoto, Japan
Recruiting
Nagasaki University Hospital
Nagasaki, Japan
Recruiting
Ito Hospital
Shibuya City, Japan
Recruiting
SHOWA Medical University Northern Yokohama Hospital
Yokohama, Japan
Recruiting
Tottori University Hospital
Yonago, Japan
Recruiting
LTD M & M Centers
Adazi, Latvia
Recruiting
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, Kauno, Lithuania
Recruiting
Klaipeda's University Hospital
Klaipėda, Lithuania
Recruiting
Osrodek Medyczny Osteomed
Krakow, Lesser Poland Voivodeship, Poland
Recruiting
NZOZ Holsamed- Oddzial Libero
Katowice, Silesian Voivodeship, Poland
Recruiting
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz, Poland
Recruiting
ETC Zamosc
Zamość, Poland
Recruiting
Clinical Hospital of Emergency Sibiu Ambulatory if Endocrinology
Sibiu, Sibiu County, Romania
Recruiting
Instituto De Investigacion Marques De Valdecilla (IDIVAL
Santander, Spain
Recruiting
Showing 29 of 29 sites. 29 of the 29 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07596849. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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