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ADAPT Forward 1 - ISA1 - en undersøgelse til evaluering af Empasiprubart IV som tillægsterapi til Efgartigimod IV hos deltagere med AChR-Ab-seropositiv generaliseret myasthenia gravis med en delvis klinisk respons til Efgartigimod

23. september 2026 opdateret af: argenx

En ISA til Masterprotokol ARGX-999-2-MG-2000 til en eksplorativ, fase 2a, proof-of-concept undersøgelse for at evaluere sikkerhed, tolerabilitet og effekt af Empasiprubart IV som add-on terapi til Efgartigimod IV hos deltagere med AChR-Ab seropositiv generaliseret myasthenia gravis med en delvis klinisk respons til Efgartigimod

This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.

The aim of this ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis.

The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170

More information can be found here: https://clinicaltrials.argenx.com/adaptforward1

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Once the master protocol and ISA1 screening periods are completed, eligible participants can enroll in the run-in period (part A) where they will receive efgartigimod IV. Eligible participants can then continue to the add-on period (part B) where they will receive both efgartigimod IV and empasiprubart IV.

Participants who are not eligible for part B will continue directly to the safety follow-up period (part C) where they will receive efgartigimod IV only.

The study duration for each participant is approximately up to 54 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Belgien
      • Leuven, Belgien, 3000
  • Forenede Stater
    • California
      • Carlsbad, California, Forenede Stater, 92011
        • Rekruttering
        • Profound Research LLC - Carlsbad
        • Kontakt:
    • Florida
      • Miami, Florida, Forenede Stater, 33176
        • Rekruttering
        • Visionary Investigators Network
        • Kontakt:
      • Tampa, Florida, Forenede Stater, 33620
        • Rekruttering
        • University of South Florida
        • Kontakt:
          • Tuan Vu, MD
          • Telefonnummer: 813-974-9413
          • E-mail: tvu6@usf.edu
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114-2621
        • Rekruttering
        • Massachusetts General Hospital
        • Kontakt:
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202-2608
        • Rekruttering
        • Henry Ford Health Systems
        • Kontakt:
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Rekruttering
        • Profound Research LLC at Las Vegas Neurology Center
        • Kontakt:
    • New York
      • Amherst, New York, Forenede Stater, 14226
        • Rekruttering
        • Dent Neurologic Institute - Amherst
        • Kontakt:
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27514-4221
        • Rekruttering
        • University of North Caroline at Chapel Hill-170 Manning Dr
        • Kontakt:
      • Durham, North Carolina, Forenede Stater, 27710-0001
        • Rekruttering
        • Duke Early Phase Clinical Research Unit - PPDS
        • Kontakt:
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219=2364
        • Rekruttering
        • University of Cincinnati Medical Center - Goodman St
        • Kontakt:
      • Columbus, Ohio, Forenede Stater, 43221-3502
        • Rekruttering
        • Ohio State Martha Morehouse Outpatient Care
        • Kontakt:
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37403
    • Texas
      • Austin, Texas, Forenede Stater, 78756
        • Rekruttering
        • National Neuromuscular Research Institute
        • Kontakt:
      • San Antonio, Texas, Forenede Stater, 78229
        • Rekruttering
        • University of Texas- San Antonio - Health Science Center - PPDS
        • Kontakt:
  • Grækenland
      • Athens, Grækenland, 115 28
        • Rekruttering
        • Eginitio Hospital
        • Kontakt:
      • Thessaloniki, Grækenland, 546 36
        • Rekruttering
        • AHEPA University General Hospital of Thessaloniki
        • Kontakt:
  • Italien
      • Milan, Italien, 20133
        • Rekruttering
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
        • Kontakt:
      • Naples, Italien, 80131
    • Lombardy
      • Bergamo, Lombardy, Italien, 24127
        • Rekruttering
        • ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
        • Kontakt:
  • Japan
      • Hanamaki, Japan, 025-0075
        • Rekruttering
        • General Hanamaki Hospital - Kajomachi
        • Kontakt:
      • Narita, Japan, 286-8520
        • Rekruttering
        • IUHW Narita Hospital
        • Kontakt:
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • Rekruttering
        • University of Tsukuba Hospital
        • Kontakt:
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • Rekruttering
        • St. Marianna University Hospital
        • Kontakt:
    • Miyagi
      • Sendai, Miyagi, Japan, 983-0045
        • Rekruttering
        • National Hospital Organization Sendai Medical Center
        • Kontakt:
  • Polen
      • Warsaw, Polen, 00-665
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Polen, 40-689
  • Spanien
      • Barcelona, Spanien, 08041
        • Rekruttering
        • Hospital de La Santa Creu i Sant Pau
        • Kontakt:
    • Malaga
      • Málaga, Malaga, Spanien, 29010
        • Rekruttering
        • Hospital Regional Universitario de Malaga - Hospital General
        • Kontakt:
  • Tyskland
      • Berlin, Tyskland, 10117
        • Rekruttering
        • Charité - Universitätsmedizin Berlin
        • Kontakt:
      • Göttingen, Tyskland, 37075
      • Würzburg, Tyskland, 97080
        • Rekruttering
        • Universitätsklinikum Würzburg
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab)
  • Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb
  • Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years of ISA screening or is willing to receive immunization at least 14 days before the first study drug administration

Exclusion Criteria:

  • Clinical diagnosis of systemic lupus erythematosus (SLE)
  • Any known complement deficiency
  • Current administration of a complement inhibitor or received zilucoplan or eculizumab <2 months or ravulizumab <6 months before the first study drug administration
  • Patients proven to be refractory to efgartigimod (ie, not achieving a clinically meaningful improvement in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score defined as an improvement of ≥2 points)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Efgartigimod IV + Empasiprubart IV

Participants receive efgartigimod IV in part A, B and C and empasiprubart IV in part B
Biologisk: Empasiprubart IV

Intravenous infusion of empasiprubart

Biologisk: Efgartigimod IV

Intravenous infusion of efgartigimod
Eksperimentel: Efgartigimod IV (part A + C)

Participants not eligible for part B, receiving efgartigimod IV in part A and C
Biologisk: Efgartigimod IV

Intravenous infusion of efgartigimod

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Forekomst af bivirkninger og alvorlige bivirkninger i del A og B
Tidsramme: Op til 21 uger
Op til 21 uger

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MG-ADL total score change from baseline at week 18 in part B (cycle 2 day 29) compared with MG ADL total score change from baseline at week 4 in part A
Tidsramme: Up to 18 weeks

The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms)
Up to 18 weeks
Proportion of participants reaching MSE at any point in part B cycles 1 and 2, and part B cycles 1 or 2
Tidsramme: Up to 21 weeks

MSE: Minimal symptom expression
Up to 21 weeks
MG-ADL total score changes from baseline over time in part B compared with part A
Tidsramme: Up to 21 weeks

The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms)
Up to 21 weeks
QMG total score change from baseline at week 18 in part B (cycle 2 day 29) compared with QMG total score change from baseline at week 4 in part A
Tidsramme: Up to 18 weeks

The Quantitative myasthenia gravis (QMG) includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no disease severity) to 39 (highest disease severity)
Up to 18 weeks
QMG total score changes from baseline over time in part B compared with part A
Tidsramme: Up to 21 weeks

The Quantitative myasthenia gravis (QMG) includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no disease severity) to 39 (highest disease severity)
Up to 21 weeks
Proportion of participants who have a 50% MG ADL total score improvement in part B cycles 1 and 2
Tidsramme: Up to 21 weeks

The Myasthenia Gravis Activities of Daily Living (MG ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms)
Up to 21 weeks
Proportion of participants who have positive PASS in part B cycles 1 and 2, and part B cycles 1 or 2
Tidsramme: Up to 21 weeks

PASS: Patient acceptable symptom state
Up to 21 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

argenx

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. december 2025

Primær færdiggørelse (Anslået)

7. marts 2028

Studieafslutning (Anslået)

7. marts 2028

Datoer for studieregistrering

Først indsendt

8. december 2025

Først indsendt, der opfyldte QC-kriterier

8. december 2025

Først opslået (Faktiske)

16. december 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ARGX-999-2-MG-20001
  • 2025-522492-28-00 (Ctis)
  • 2025 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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