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

16 september 2026 bijgewerkt door: argenx

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

230

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Bulgarije
      • Sliven, Bulgarije, 8800
        • Actief, niet wervend
        • Multiprofile Hospital for Active Treatment Hadzhi Dimitar OOD
  • Canada
      • Surrey, Canada, V3T 2V6
        • Werving
        • TLC Diabetes and Endocrinology Clinic
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H4J1E3
        • Actief, niet wervend
        • Endocrinologie Oasis
  • Georgië
      • Batumi, Georgië, 6000
        • Werving
        • High Technology Hospital Medcenter LLC
        • Contact:
      • Tbilisi, Georgië, 0160
        • Werving
        • LTD MediClub Georgia
        • Contact:
      • Tbilisi, Georgië, 0102
  • Japan
      • Iizuka, Japan, 820-8505
        • Werving
        • Aso Iizuka Hospital
        • Contact:
      • Kawasaki, Japan, 211-8533
        • Werving
        • Nippon Medical School Musashikosugi Hospital
        • Contact:
      • Kitakyushu, Japan, 807-8556
        • Werving
        • Hospital of University of Occupational and Environmental Health
        • Contact:
      • Kyoto, Japan, 612-0861
        • Werving
        • National Hospital Organization Kyoto Medical Center
        • Contact:
      • Nagasaki, Japan, 852-8501
        • Werving
        • Nagasaki University Hospital
        • Contact:
      • Shibuya City, Japan, 150-8308
      • Yokohama, Japan, 224-8503
      • Yonago, Japan, 683-8504
  • Litouwen
    • Kauno
      • Kaunas, Kauno, Litouwen, 50161
        • Actief, niet wervend
        • Hospital of Lithuanian University of Health Sciences Kaunas
  • Polen
      • Bydgoszcz, Polen, 85-605
        • Actief, niet wervend
        • Centrum Medyczne Intercor Sp. z o.o.
      • Zamość, Polen, 22400
        • Actief, niet wervend
        • ETC Zamosc

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Part A - efgartigimod PH20 SC PFS
Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period.
Biologisch: efgartigimod PH20 SC
Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)
Placebo-vergelijker: Part A - placebo PH20 SC PFS
Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period.
Ander: Placebo PH20 SC
Subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)
Experimenteel: Part B - efgartigimod PH20 SC PFS
Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period.
Biologisch: efgartigimod PH20 SC
Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)
Experimenteel: Part B - placebo PH20 SC PFS
Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period.
Ander: Placebo PH20 SC
Subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)
Experimenteel: Part C - efgartigimod PH20 SC PFS
Participants, will receive efgartigimod PH20 SC PFS in the part C open-label treatment period
Biologisch: efgartigimod PH20 SC
Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part A
Tijdsspanne: up to 24 weeks (part A)
free triiodothyronine: [fT3]; free thyroxine: [fT4]; ATDs: antithyroid drugs
up to 24 weeks (part A)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to becoming euthyroid off ATDs in part A
Tijdsspanne: Up to 24 weeks (part A)
ATDs: antithyroid drugs
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
Tijdsspanne: up to 24 weeks (part A)
MMI: methimazole (also known as thiamazole); CBZ carbimazole
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
Tijdsspanne: Up to 24 weeks (part A)
ULN : upper limit of normal; ATDs: antithyroid drugs
Up to 24 weeks (part A)
Percentage of participants who are euthyroid off ATDs and TRAb seronegative at week 24 in part A
Tijdsspanne: up to 24 weeks (part A)
TRAb: anti-TSHR autoantibodies; ATDs: antithyroid drugs
up to 24 weeks (part A)
Time to becoming euthyroid off ATDs and TRAb seronegative
Tijdsspanne: up to 24 weeks (part A) + up to 135 weeks
ATDs: antithyroid drugs; TRAb: anti-TSHR autoantibodies
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)
Tijdsspanne: up to 24 weeks
ATDs: antithyroid drugs; MMI: methimazole (also known as thiamazole); CBZ carbimazole
up to 24 weeks
Time to becoming euthyroid
Tijdsspanne: up to 24 weeks (part A) + up to 135 weeks
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)
Tijdsspanne: up to 24 weeks (part A)
ULN : upper limit of normal
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)
Tijdsspanne: up to 24 weeks (part A)
TSH: thyroid-stimulating hormone; LLN: lower limit of normal
up to 24 weeks (part A)
Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS for 6, 12, and 18 months
Tijdsspanne: up to 74 weeks (part B) + up to 135 weeks
ATDs: antithyroid drug
up to 74 weeks (part B) + up to 135 weeks
Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS
Tijdsspanne: up to 72 weeks (part C)
ATDs: antithyroid drug
up to 72 weeks (part C)
Incidence of AEs and SAEs
Tijdsspanne: up to 135 weeks
AEs: adverse events ; SAEs: serious adverse events
up to 135 weeks
Change in ThyPRO-39 over time
Tijdsspanne: Up to 135 weeks
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
Up to 135 weeks
Change in PROMIS-PF10a over time
Tijdsspanne: up to 135 weeks
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.
up to 135 weeks
Efgartigimod serum concentrations over time
Tijdsspanne: up to 24 weeks (part A) + 72 weeks (part C)
up to 24 weeks (part A) + 72 weeks (part C)
Percentage change from baseline in total IgG levels in serum over time
Tijdsspanne: up to 98 weeks
IgG: immunoglobulin G
up to 98 weeks
Percentage change from baseline in TRAb serum levels over time
Tijdsspanne: up to 135 weeks
TRAb: anti-TSHR autoantibodies
up to 135 weeks
Incidence of ADA against efgartigimod in serum
Tijdsspanne: up to 24 weeks (part A) + up to 135 weeks
ADA: antidrug antibody(ies)
up to 24 weeks (part A) + up to 135 weeks
Incidence of antibodies against rHuPH20 in plasma
Tijdsspanne: up to 24 weeks (part A) + Up to 135 weeks
rHuPH20: recombinant human hyaluronidase PH20
up to 24 weeks (part A) + Up to 135 weeks
Incidence of NAb against efgartigimod in serum and rHuPH20 in plasma
Tijdsspanne: up to 24 weeks (part A) + up to 135 weeks
NAb: neutralizing antibody(ies); rHuPH20: recombinant human hyaluronidase PH20
up to 24 weeks (part A) + up to 135 weeks
Percentage of participants who remain euthyroid off ATDs
Tijdsspanne: Up to 50 weeks (part B)
ATDs: antithyroid drug
Up to 50 weeks (part B)
Percentage of participants who are euthyroid and receiving MMI ≤5 mg/day or CBZ ≤7.5 mg/day
Tijdsspanne: Up to 50 weeks (part B)
ATDs: antithyroid drug
Up to 50 weeks (part B)
Percentage of participants who remain euthyroid without ATDs
Tijdsspanne: up to 98 weeks (part B)
ATDs: antithyroid drug
up to 98 weeks (part B)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

argenx

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 juni 2026

Primaire voltooiing (Geschat)

1 juni 2028

Studie voltooiing (Geschat)

1 mei 2030

Studieregistratiedata

Eerst ingediend

13 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 mei 2026

Eerst geplaatst (Werkelijk)

19 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 september 2026

Laatste update ingediend die voldeed aan QC-criteria

16 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ARGX-113-25-GRD-3001
  • 2025 (Subsidie/contract van de Amerikaanse NIH: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523333-26-00 (Ctis)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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