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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 oppdatert av: 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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

230

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Part A - efgartigimod PH20 SC PFS
Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period.
Biologisk: efgartigimod PH20 SC
Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)
Placebo komparator: Part A - placebo PH20 SC PFS
Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period.
Annen: Placebo PH20 SC
Subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)
Eksperimentell: Part B - efgartigimod PH20 SC PFS
Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period.
Biologisk: efgartigimod PH20 SC
Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)
Eksperimentell: Part B - placebo PH20 SC PFS
Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period.
Annen: Placebo PH20 SC
Subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)
Eksperimentell: Part C - efgartigimod PH20 SC PFS
Participants, will receive efgartigimod PH20 SC PFS in the part C open-label treatment period
Biologisk: efgartigimod PH20 SC
Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to becoming euthyroid off ATDs in part A
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: up to 24 weeks
ATDs: antithyroid drugs; MMI: methimazole (also known as thiamazole); CBZ carbimazole
up to 24 weeks
Time to becoming euthyroid
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: up to 72 weeks (part C)
ATDs: antithyroid drug
up to 72 weeks (part C)
Incidence of AEs and SAEs
Tidsramme: up to 135 weeks
AEs: adverse events ; SAEs: serious adverse events
up to 135 weeks
Change in ThyPRO-39 over time
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: up to 98 weeks
IgG: immunoglobulin G
up to 98 weeks
Percentage change from baseline in TRAb serum levels over time
Tidsramme: up to 135 weeks
TRAb: anti-TSHR autoantibodies
up to 135 weeks
Incidence of ADA against efgartigimod in serum
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 50 weeks (part B)
ATDs: antithyroid drug
Up to 50 weeks (part B)
Percentage of participants who remain euthyroid without ATDs
Tidsramme: up to 98 weeks (part B)
ATDs: antithyroid drug
up to 98 weeks (part B)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

argenx

Publikasjoner og nyttige lenker

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Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. juni 2026

Primær fullføring (Antatt)

1. juni 2028

Studiet fullført (Antatt)

1. mai 2030

Datoer for studieregistrering

Først innsendt

13. mai 2026

Først innsendt som oppfylte QC-kriteriene

13. mai 2026

Først lagt ut (Faktiske)

19. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ARGX-113-25-GRD-3001
  • 2025 (U.S. NIH-stipend/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523333-26-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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