RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: argenx • ClinicalTrials.gov ID: NCT07596849

Registry updated: 2026-10-16

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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. 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

Interventions

efgartigimod PH20 SC (Biological)
Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)
Placebo PH20 SC (Other)
Subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)

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

Conditions

Graves Disease

Locations

AZORG Ziekenhuis — Aalst, Oost-Vlass, Belgium
Universitair Ziekenhuis Gent — Ghent, Belgium
Medical Center Tonus - 2013 OOD — Pazardzhik, Bulgaria
DCC Pulmed — Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment Hadzhi Dimitar OOD — Sliven, Bulgaria
Medical Center Kalimat — Sofia, Bulgaria
Diagnostic Consultative Center Ekvita OOD — Varna, Bulgaria
MC Klinika Nova — Varna, Bulgaria
Multi-Profile District Hospital for Active Treatment Dr. Stefan Cherkezov — Veliko Tarnovo, Bulgaria
Endocrinologie Oasis — Montreal, Quebec, Canada
TLC Diabetes and Endocrinology Clinic — Surrey, Canada
Nordsjaellands Hospital - Hillerod — Hillerød, Capital Region, Denmark
High Technology Hospital Medcenter LLC — Batumi, Georgia
First Medical Clinic Ltd — Tbilisi, Georgia
LTD MediClub Georgia — Tbilisi, Georgia
Institut fuer Praeventive Medizin & Klinische Forschung — Magdeburg, Germany
Okayama University Hospital — Okayama, Okayama-ken, Japan
Juntendo University Hospital — Bunkyō-Ku, Tokyo, Japan
Toho University Omori Medical Center — Ōta-ku, Tokyo, Japan
Aso Iizuka Hospital — Iizuka, Japan
Nippon Medical School Musashikosugi Hospital — Kawasaki, Japan
Hospital of University of Occupational and Environmental Health — Kitakyushu, Japan
National Hospital Organization Kyoto Medical Center — Kyoto, Japan
Nagasaki University Hospital — Nagasaki, Japan
Ito Hospital — Shibuya City, Japan
SHOWA Medical University Northern Yokohama Hospital — Yokohama, Japan
Tottori University Hospital — Yonago, Japan
LTD M & M Centers — Adazi, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas — Kaunas, Kauno, Lithuania
Klaipeda's University Hospital — Klaipėda, Lithuania
Osrodek Medyczny Osteomed — Krakow, Lesser Poland Voivodeship, Poland
NZOZ Holsamed- Oddzial Libero — Katowice, Silesian Voivodeship, Poland
Centrum Medyczne INTERCOR Sp. z o.o. — Bydgoszcz, Poland
DIABET Centrum Medyczne s.c. — Chrzanów, Poland
Reumed Sp Z O.O. — Lublin, Poland
Etg Warszawa Sp. z o.o. — Warsaw, Poland
ETC Zamosc — Zamość, Poland
Clinical Hospital of Emergency Sibiu Ambulatory if Endocrinology — Sibiu, Sibiu County, Romania
Hospital Universitario De La Ribera — Alzira, Spain
Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
Instituto De Investigacion Marques De Valdecilla (IDIVAL — Santander, Spain
"Universidad de Sevilla - Hospital Universitario Virgen Macarena" — Seville, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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