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

Last updated: November 2, 2026
Sponsor: argenx
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

efgartigimod PH20 SC

Placebo PH20 SC

Clinical Study ID

NCT07596849
ARGX-113-25-GRD-3001
2025
2025-523333-26-00
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is at least 18 years of age and the local legal age of consent for clinical studieswhen 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) <0.1mIU/L at screening

  • Has been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 monthsbefore screening

Exclusion

Exclusion Criteria:

  • History of hyperthyroidism not caused by GD (eg, toxic adenoma or toxic multinodulargoiter)

  • 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 weeksbefore screening

  • Any complication of hyperthyroidism or underlying medical condition that would putthe participant at undue risk. This includes arrhythmia or tachyarrhythmia relatedto GD, such as atrial fibrillation or atrial flutter not sufficiently controlledwith medications.

  • Graves' orbitopathy/Thyroid Eye Disease (GO/TED) requiring systemic therapy (eg,corticosteroids), orbital injections, orbital surgery, or orbital radiation, orexpected immediate surgical intervention and/or planned correctivesurgery/irradiation or medical therapy during the study

Study Design

Total Participants: 230
Treatment Group(s): 2
Primary Treatment: efgartigimod PH20 SC
Phase: 3
Study Start date:
June 10, 2026
Estimated Completion Date:
May 31, 2030

Connect with a study center

  • AZORG Ziekenhuis

    Aalst, Oost-Vlass 9300
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 9000
    Belgium

    Active - Recruiting

  • Medical Center Tonus - 2013 OOD

    Pazardzhik, 4400
    Bulgaria

    Active - Recruiting

  • DCC Pulmed

    Plovdiv, 4002
    Bulgaria

    Active - Recruiting

  • Multiprofile Hospital for Active Treatment Hadzhi Dimitar OOD

    Sliven, 8800
    Bulgaria

    Active - Recruiting

  • Medical Center Kalimat

    Sofia, 1680
    Bulgaria

    Active - Recruiting

  • Diagnostic Consultative Center Ekvita OOD

    Varna, 9000
    Bulgaria

    Active - Recruiting

  • MC Klinika Nova

    Varna, 9000
    Bulgaria

    Active - Recruiting

  • Multi-Profile District Hospital for Active Treatment Dr. Stefan Cherkezov

    Veliko Tarnovo, 5000
    Bulgaria

    Active - Recruiting

  • Endocrinologie Oasis

    Montreal, Quebec H4J1E3
    Canada

    Active - Recruiting

  • TLC Diabetes and Endocrinology Clinic

    Surrey, V3T 2V6
    Canada

    Active - Recruiting

  • Nordsjaellands Hospital - Hillerod

    Hillerød, Capital Region 3400
    Denmark

    Active - Recruiting

  • High Technology Hospital Medcenter LLC

    Batumi, 6000
    Georgia

    Active - Recruiting

  • First Medical Clinic Ltd

    Tbilisi, 0102
    Georgia

    Active - Recruiting

  • LTD MediClub Georgia

    Tbilisi, 0160
    Georgia

    Active - Recruiting

  • Institut fuer Praeventive Medizin & Klinische Forschung

    Magdeburg, 39110
    Germany

    Active - Recruiting

  • Athens Medical Center

    Athens, 15125
    Greece

    Active - Recruiting

  • Evangelismos Hospital

    Athens, 10676
    Greece

    Active - Recruiting

  • AOU Ospedali Riuniti di Ancona Umberto I-G.M. Lancisi-G. Salesi

    Ancona, 60126
    Italy

    Active - Recruiting

  • Okayama University Hospital

    Okayama, Okayama-ken 700-8558
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Bunkyō-Ku, Tokyo 113-8431
    Japan

    Active - Recruiting

  • Toho University Omori Medical Center

    Ōta-ku, Tokyo 143-8541
    Japan

    Active - Recruiting

  • Aso Iizuka Hospital

    Iizuka, 820-8505
    Japan

    Active - Recruiting

  • Nippon Medical School Musashikosugi Hospital

    Kawasaki, 211-8533
    Japan

    Active - Recruiting

  • Hospital of University of Occupational and Environmental Health

    Kitakyushu, 807-8556
    Japan

    Active - Recruiting

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-0861
    Japan

    Active - Recruiting

  • Nagasaki University Hospital

    Nagasaki, 852-8501
    Japan

    Active - Recruiting

  • Ito Hospital

    Shibuya City, 150-8308
    Japan

    Active - Recruiting

  • SHOWA Medical University Northern Yokohama Hospital

    Yokohama, 224-8503
    Japan

    Active - Recruiting

  • Tottori University Hospital

    Yonago, 683-8504
    Japan

    Active - Recruiting

  • LTD M & M Centers

    Adazi, LV2164
    Latvia

    Active - Recruiting

  • Veselibas centrs 4

    Riga, 1012
    Latvia

    Active - Recruiting

  • Hospital of Lithuanian University of Health Sciences Kaunas

    Kaunas, Kauno 50161
    Lithuania

    Active - Recruiting

  • Klaipeda's University Hospital

    Klaipėda, LT-92288
    Lithuania

    Active - Recruiting

  • Osrodek Medyczny Osteomed

    Krakow, Lesser Poland Voivodeship 30-074
    Poland

    Active - Recruiting

  • NZOZ Holsamed- Oddzial Libero

    Katowice, Silesian Voivodeship 40-600
    Poland

    Active - Recruiting

  • Centrum Medyczne INTERCOR Sp. z o.o.

    Bydgoszcz, 85-605
    Poland

    Active - Recruiting

  • DIABET Centrum Medyczne s.c.

    Chrzanów, 32-500
    Poland

    Active - Recruiting

  • ETG Lublin

    Lublin, 20-412
    Poland

    Active - Recruiting

  • Reumed Sp Z O.O.

    Lublin, 20607
    Poland

    Active - Recruiting

  • ETG JustMed

    Warsaw, 01-691
    Poland

    Active - Recruiting

  • Etg Warszawa Sp. z o.o.

    Warsaw, 02-677
    Poland

    Active - Recruiting

  • NZOZ GynCentrum - Oddzial Warszawa

    Warsaw, 00-124
    Poland

    Active - Recruiting

  • ETC Zamosc

    Zamość, 22400
    Poland

    Active - Recruiting

  • Clinical Hospital of Emergency Sibiu Ambulatory if Endocrinology

    Sibiu, Sibiu County 550245
    Romania

    Active - Recruiting

  • Cluj County Clinical Emergency Hospital

    Cluj-Napoca, 400396
    Romania

    Active - Recruiting

  • Hospital Universitario De La Ribera

    Alzira, 46600
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hospital Universitario de Móstoles

    Móstoles, 28935
    Spain

    Active - Recruiting

  • Instituto De Investigacion Marques De Valdecilla (IDIVAL

    Santander, 39011
    Spain

    Active - Recruiting

  • "Universidad de Sevilla - Hospital Universitario Virgen Macarena"

    Seville, 41009
    Spain

    Active - Recruiting

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