Graves DiseasePhase 3VitaliThyNCT07596849
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
A Phase 3 study testing efgartigimod PH20 SC in people with Graves Disease, run by argenx at 42 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves Disease
- What is being tested?
- efgartigimod PH20 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 42 sitesin 12 countries
- Study dates
- 10 Jun 2026to May 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
42 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
42 sites in 12 countries
Japan11 sites, 11 recruiting
- Recruiting
Juntendo University Hospital
Bunkyō-Ku, Tokyo, 113-8431
Toyoyoshi Uchida, MD, +1 857-350-4834, uchitoyo@juntendo.ac.jp
- Recruiting
Aso Iizuka Hospital
Iizuka, 820-8505
Tomoaki Inoue, MD, +81948223800, tinoueh9@aih-net.com
- Recruiting
Nippon Medical School Musashikosugi Hospital
Kawasaki, 211-8533
Yuji Yamaguchi, MD, y-yamaguchi@nms.ac.jp
- Recruiting
Hospital of University of Occupational and Environmental Health
Kitakyushu, 807-8556
Keiichi Torimoto, MD, torimoto@med.uoeh-u.ac.jp
- Recruiting
National Hospital Organization Kyoto Medical Center
Kyoto, 612-0861
Naotetsu Kanamoto, MD, +81756419161, kyotetsu@kuhp.kyoto-u.ac.jp
- Recruiting
Nagasaki University Hospital
Nagasaki, 852-8501
Ichiro Horie, MD, +81 095-819-7200, horie@nagasaki-u.ac.jp
- Recruiting
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
Tomohiro Terasaka, +1 857-350-4834, terasakat@okayama-u.ac.jp
- Recruiting
Toho University Omori Medical Center
Ōta-ku, Tokyo, 143-8541
Hiroshi Uchino, MD, +1 857-350-4834, h.uchino@med.toho-u.ac.jp
- Recruiting
Ito Hospital
Shibuya City, 150-8308
Natsuko Watanabe, MD, 81334A27411, n-watanabe@ito-hospital.jp
- Recruiting
SHOWA Medical University Northern Yokohama Hospital
Yokohama, 224-8503
Yo Kunii, MD, y-kunii@med.showa-u.ac.jp
- Recruiting
Tottori University Hospital
Yonago, 683-8504
Kazuhiko Matsuzawa, MD, k.matsuzawa@tottori-u.ac.jp
Bulgaria7 sites, 7 recruiting
- Recruiting
Medical Center Tonus - 2013 OOD
Pazardzhik, 4400
Irina Ganeva, MD, 887727155, ganeva_2022@abv.bg
- Recruiting
DCC Pulmed
Plovdiv, 4002
Mitko Mitkov, 888613947, mitko_mitkov@yahoo.com
- Recruiting
Multiprofile Hospital for Active Treatment Hadzhi Dimitar OOD
Sliven, 8800
Ghassan Farah, MD, +359 882258899, gasan_farah@mail.bg
- Recruiting
Medical Center Kalimat
Sofia, 1680
Mariana Yoncheva-Mihaylova, 889901910, mdyoncheva@gmail.com
- Recruiting
Diagnostic Consultative Center Ekvita OOD
Varna, 9000
Neli Klyuchkova, MD, 888602415, klyuchkova@gmail.com
- Recruiting
MC Klinika Nova
Varna, 9000
Gergana Marinova, 878200805, gergana_tosheva@abv.bg
- Recruiting
Multi-Profile District Hospital for Active Treatment Dr. Stefan Cherkezov
Veliko Tarnovo, 5000
Nayme Sirachka, 888910988, dr.nsirachka@mail.bg
Poland7 sites, 7 recruiting
- Recruiting
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz, 85-605
Roman Junik, MD, +48 525854020, junikroman@gmail.com
- Recruiting
DIABET Centrum Medyczne s.c.
Chrzanów, 32-500
Leszek Romanowski, 326231373, leszek.romanowski@diabet.com.pl
- Recruiting
NZOZ Holsamed- Oddzial Libero
Katowice, Silesian Voivodeship, 40-600
Anna Bednarska-Czerwinska, MD, 606634792, a.czerwinska@holsaclinical.com
- Recruiting
Osrodek Medyczny Osteomed
Krakow, Lesser Poland Voivodeship, 30-074
Miroslaw Szlachcic, MD, +1 857-350-4834, m.szlachcic@medistica.com.pl
- Recruiting
Reumed Sp Z O.O.
Lublin, 20607
Agnieszka Zwolak, 695682826, zwolakag@wp.pl
- Recruiting
Etg Warszawa Sp. z o.o.
Warsaw, 02-677
Michal Lis, +1 857-350-4834, m.lis@etg-network.com
- Recruiting
ETC Zamosc
Zamość, 22400
Dorota Boniek-Poprawa, MD, +48 696778747, d.boniekpoprawa@etg-network.com
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitario De La Ribera
Alzira, 46600
Carmen Fajardo Montanana, 962542758, fajardo_carmon@gva.es
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Jose Maria Cubero Marcos, +1 857-350-4834, jcubero@santpau.cat
- Recruiting
Instituto De Investigacion Marques De Valdecilla (IDIVAL
Santander, 39011
Luis Alberto Vazquez-Salvi, MD, 639659866, luisalberto.vazquez@scsalud.es
- Recruiting
"Universidad de Sevilla - Hospital Universitario Virgen Macarena"
Seville, 41009
Clara Garcia Garcia, +1 857-350-4834, clara.garcia.garcia.sspa@juntadeandalucia.es
Georgia3 sites, 3 recruiting
- Recruiting
High Technology Hospital Medcenter LLC
Batumi, 6000
Inga Abesadze, MD, +995577137404, ingaabesadze777@gmail.com
- Recruiting
First Medical Clinic Ltd
Tbilisi, 0102
Maia Rekhviashvili, MD, rekhviashvili67@yahoo.com
- Recruiting
LTD MediClub Georgia
Tbilisi, 0160
Nino Dolidze, MD, +995600000000, n.dolidze@mcg.ge
Belgium2 sites, 2 recruiting
- Recruiting
AZORG Ziekenhuis
Aalst, Oost-Vlass, 9300
Katrien Wierckx, 5372448805, katrien.wierckx@azorg.be
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
Bruno Lapauw, +32 93 32 21 11, bruno.lapauw@uzgent.be
Canada2 sites, 2 recruiting
- Recruiting
Endocrinologie Oasis
Montreal, Quebec, H4J1E3
Zeina Yared, MD, 514-744-5620, zyared@endocrinologieoasis.com
- Recruiting
TLC Diabetes and Endocrinology Clinic
Surrey, V3T 2V6
Akshay Jain, MD, +14032883224, oxyjain@gmail.com
Lithuania2 sites, 2 recruiting
- Recruiting
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, Kauno, 50161
Dzilda Velickiene, MD, +370 61525975, vdzilda@gmail.com
- Recruiting
Klaipeda's University Hospital
Klaipėda, LT-92288
Arunas Pangonis, +370 612 38 662, arunas.pangonis@kulig.lt
Denmark1 site, 1 recruiting
- Recruiting
Nordsjaellands Hospital - Hillerod
Hillerød, Capital Region, 3400
Peter Kristensen, 4540845013, peter.lommer.kristensen.01@regionh.dk
Germany1 site, 1 recruiting
- Recruiting
Institut fuer Praeventive Medizin & Klinische Forschung
Magdeburg, 39110
Ruediger Moericke, 3917273904, prof.moericke@praxis-moericke.de
Latvia1 site, 1 recruiting
- Recruiting
LTD M & M Centers
Adazi, LV2164
Dace Pavlova, 26164281, dacepavlova@inbox.lv
Romania1 site, 1 recruiting
- Recruiting
Clinical Hospital of Emergency Sibiu Ambulatory if Endocrinology
Sibiu, Sibiu County, 550245
Mihaela Stancia, MD, 744266375, mihaela.stanciu@yahoo.com
About this study
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
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.
Read more
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
- Being tested
- efgartigimod PH20 SC, Placebo PH20 SC
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efgartigimod PH20 SCBiological
Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)
Placebo PH20 SCOther
Subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)
| Study group | Role | What they receive |
|---|---|---|
| Part A - efgartigimod PH20 SC PFS | Experimental | Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period. Receives: Biological: efgartigimod PH20 SC |
| Part A - placebo PH20 SC PFS | Placebo comparator | Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period. Receives: Other: Placebo PH20 SC |
| Part B - efgartigimod PH20 SC PFS | Experimental | Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period. Receives: Biological: efgartigimod PH20 SC |
| Part B - placebo PH20 SC PFS | Experimental | Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period. Receives: Other: Placebo PH20 SC |
| Part C - efgartigimod PH20 SC PFS | Experimental | Participants, will receive efgartigimod PH20 SC PFS in the part C open-label treatment period Receives: Biological: efgartigimod PH20 SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part A
free triiodothyronine: [fT3]; free thyroxine: [fT4]; ATDs: antithyroid drugs
Measured: up to 24 weeks (part A)
Secondary outcomes (23)
Time to becoming euthyroid off ATDs in part A
ATDs: antithyroid drugs
Measured: Up to 24 weeks (part A)
Percentage of participants who are euthyroid and receiving MMI ≤5 mg/day or CBZ ≤7.5 mg/day at week 24 in part A
MMI: methimazole (also known as thiamazole); CBZ carbimazole
Measured: up to 24 weeks (part A)
Percentage of participants with fT3 and fT4 levels below the ULN off ATDs at week 24 in part A
ULN : upper limit of normal; ATDs: antithyroid drugs
Measured: Up to 24 weeks (part A)
Percentage of participants who are euthyroid off ATDs and TRAb seronegative at week 24 in part A
TRAb: anti-TSHR autoantibodies; ATDs: antithyroid drugs
Measured: up to 24 weeks (part A)
Time to becoming euthyroid off ATDs and TRAb seronegative
ATDs: antithyroid drugs; TRAb: anti-TSHR autoantibodies
Measured: up to 24 weeks (part A) + up to 135 weeks
Time to becoming euthyroid and receiving an ATD dose of MMI ≤5 mg/day or CBZ ≤7.5 mg/day (part A)
ATDs: antithyroid drugs; MMI: methimazole (also known as thiamazole); CBZ carbimazole
Measured: up to 24 weeks
Time to becoming euthyroid
Measured: up to 24 weeks (part A) + up to 135 weeks
Time to having fT3 and fT4 levels within normal ranges among participants who had fT3 and/or fT4 more than the ULN at baseline (part A)
ULN : upper limit of normal
Measured: up to 24 weeks (part A)
Time to having TSH within normal ranges among participants who have TSH lower than the LLN at baseline (part A)
TSH: thyroid-stimulating hormone; LLN: lower limit of normal
Measured: up to 24 weeks (part A)
Percentage of participants who remain euthyroid off ATDs
ATDs: antithyroid drug
Measured: Up to 50 weeks (part B)
Percentage of participants who are euthyroid and receiving MMI ≤5 mg/day or CBZ ≤7.5 mg/day
ATDs: antithyroid drug
Measured: Up to 50 weeks (part B)
Percentage of participants who remain euthyroid without ATDs
ATDs: antithyroid drug
Measured: up to 98 weeks (part B)
Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS for 6, 12, and 18 months
ATDs: antithyroid drug
Measured: up to 74 weeks (part B) + up to 135 weeks
Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS
ATDs: antithyroid drug
Measured: up to 72 weeks (part C)
Incidence of AEs and SAEs
AEs: adverse events ; SAEs: serious adverse events
Measured: up to 135 weeks
Change in ThyPRO-39 over time
The Thyroid-Specific Patient-Reported Outcome Short Form (ThyPRO-39) 39 item version of the ThyPRO. Each item is related to a specific aspect of the participant's experience with their thyroid condition. Each item is scored on a 5-point Likert scale, and the scores are then transformed to a 0-to-100 scale. Higher scores indicate worse health status
Measured: Up to 135 weeks
Change in PROMIS-PF10a over time
The Patient-Reported Outcomes Measurement Information System Physical Function-10 item (PROMIS-PF10a) is a self- administered physical functioning assessment comprising 10 items that measure respondents' ability to perform common physical tasks. Scoring involves summing the numerical responses to each item; higher scores indicate better physical function.
Measured: up to 135 weeks
Efgartigimod serum concentrations over time
Measured: up to 24 weeks (part A) + 72 weeks (part C)
Percentage change from baseline in total IgG levels in serum over time
IgG: immunoglobulin G
Measured: up to 98 weeks
Percentage change from baseline in TRAb serum levels over time
TRAb: anti-TSHR autoantibodies
Measured: up to 135 weeks
Incidence of ADA against efgartigimod in serum
ADA: antidrug antibody(ies)
Measured: up to 24 weeks (part A) + up to 135 weeks
Incidence of antibodies against rHuPH20 in plasma
rHuPH20: recombinant human hyaluronidase PH20
Measured: up to 24 weeks (part A) + Up to 135 weeks
Incidence of NAb against efgartigimod in serum and rHuPH20 in plasma
NAb: neutralizing antibody(ies); rHuPH20: recombinant human hyaluronidase PH20
Measured: up to 24 weeks (part A) + up to 135 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start10 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596849
- Sponsor's protocol ID
- ARGX-113-25-GRD-3001
- Other IDs
- 2025-523333-26-00, 2025
- Acronym
- VitaliThy
- Status last verified
- Sep 2026
- First submitted
- 13 May 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No