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En undersøgelse til vurdering af effektivitet og sikkerhed for empasiprubart versus IVIG hos voksne med CIDP (emvigorate)

2. november 2026 opdateret af: argenx

En fase 3, randomiseret, dobbeltblindet, dobbelt-dummy-undersøgelse, der vurderer effektiviteten og sikkerheden af ​​intravenøs empasiprubart versus intravenøs immunoglobulin hos voksne med kronisk inflammatorisk demyeliniserende polyneuropati

The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks (6 months). Following Part A, participants will enter Part B in which all participants will receive empasiprubart for 96 weeks (24 months).

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

218

Fase

  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Argentina
      • Córdoba, Argentina, X5004AOA
        • Rekruttering
        • Instituto Privado Kremer
        • Kontakt:
      • Rosario, Argentina, S2000DTP
        • Rekruttering
        • INECO Neurociencias Oroño
        • Kontakt:
  • Australien
    • New South Wales
      • Liverpool, New South Wales, Australien, 2179
        • Rekruttering
        • Liverpool Hospital
        • Kontakt:
  • Brasilien
      • Salvador, Brasilien, 40290-000
        • Rekruttering
        • Escola Bahiana de Medicina e Saude Publica
        • Kontakt:
      • São Paulo, Brasilien, 04038-002
        • Rekruttering
        • PSEG Centro de Pesquisa Clinica
        • Kontakt:
    • São Paulo
      • São Paulo, São Paulo, Brasilien, 04038-002
        • Rekruttering
        • PSEG Centro de Pesquisa Clinica - Rua Borges Lagoa 1060
        • Kontakt:
  • Canada
      • Edmonton, Canada, T6G 2G3
        • Rekruttering
        • University of Alberta
        • Kontakt:
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Rekruttering
        • University of Calgary
        • Kontakt:
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z2C7
        • Rekruttering
        • Black Tusk Research Group
        • Kontakt:
  • Colombia
      • Bogotá, Colombia, 110231
        • Rekruttering
        • Hospital Universitario San Ignacio
        • Kontakt:
      • Medellín, Colombia, 50012
        • Rekruttering
        • Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico
        • Kontakt:
      • Medellín, Colombia, 50012
        • Rekruttering
        • Hospital Alma Máter de Antioquia
        • Kontakt:
  • Det Forenede Kongerige
      • Leeds, Det Forenede Kongerige, LS1 3EX
      • London, Det Forenede Kongerige, WC1N 3BG
        • Rekruttering
        • The National Hospital for Neurology and Neurosurgery - PPDS
        • Kontakt:
    • Lancashire
      • Salford, Lancashire, Det Forenede Kongerige, M6 8HD
        • Rekruttering
        • Salford Royal Hospital - PPDS
        • Kontakt:
  • Estland
      • Tallinn, Estland, 11315
      • Tartu, Estland, 50406
        • Rekruttering
        • Tartu University Hospital
        • Kontakt:
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Rekruttering
        • University of Alabama
        • Kontakt:
          • Eroboghene Ubogu, MD
          • Telefonnummer: 857-350-4834
          • E-mail: ubogu@uab.edu
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85719-4330
        • Rekruttering
        • Banner University of Arizona Medical Center
        • Kontakt:
    • California
      • Rancho Mirage, California, Forenede Stater, 922701
        • Rekruttering
        • Samir Macwan, M.D., Inc.
        • Kontakt:
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Rekruttering
        • Colorado Springs Neurological Associates
        • Kontakt:
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20010
        • Rekruttering
        • MedStar Washington Hospital Center
        • Kontakt:
    • Florida
      • Homestead, Florida, Forenede Stater, 33033
      • Miami, Florida, Forenede Stater, 33133
        • Rekruttering
        • Visionary Investigators Network
        • Kontakt:
      • Tampa, Florida, Forenede Stater, 33616
        • Rekruttering
        • University of South Florida
        • Kontakt:
    • Kentucky
      • Nicholasville, Kentucky, Forenede Stater, 40356-6066
        • Rekruttering
        • Baptist Health Medical Group Neurology
        • Kontakt:
    • Louisiana
      • Slidell, Louisiana, Forenede Stater, 70458
        • Rekruttering
        • Paradigm Health System
        • Kontakt:
    • Maryland
      • Columbia, Maryland, Forenede Stater, 21044
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Rekruttering
        • University of Michigan Hospital
        • Kontakt:
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267-2827
        • Rekruttering
        • University of Cincinnati Health
        • Kontakt:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Rekruttering
        • Jefferson Health Honickman Center
        • Kontakt:
      • Philadelphia, Pennsylvania, Forenede Stater, 19104-5127
        • Rekruttering
        • Perelman Center for Advanced Medicine
        • Kontakt:
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37909
        • Rekruttering
        • University Neurology
        • Kontakt:
    • Texas
      • Houston, Texas, Forenede Stater, 77094
      • Irving, Texas, Forenede Stater, 75063
        • Rekruttering
        • National Neuromuscular Research Institute
        • Kontakt:
  • Frankrig
      • Bordeaux, Frankrig, 33076
      • Le Kremlin-Bicêtre, Frankrig, 94270
      • Nice, Frankrig, 6001
        • Rekruttering
        • CHU de Nice-Hôpital Pasteur
        • Kontakt:
      • Strasbourg, Frankrig, 67200
      • Toulouse, Frankrig, 31059
        • Rekruttering
        • CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
        • Kontakt:
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, Frankrig, 13005
        • Rekruttering
        • AP-HM- Hôpital de La Timone
        • Kontakt:
    • Paris
      • Paris, Paris, Frankrig, 75013
        • Rekruttering
        • AP-HP - Hôpital de la Pitié Salpétrière
        • Kontakt:
  • Grækenland
      • Athens, Grækenland, 15562
        • Rekruttering
        • University General Hospital of Alexandroupolis
        • Kontakt:
      • Chaïdári, Grækenland, 124 62
        • Rekruttering
        • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
        • Kontakt:
  • Holland
      • Utrecht, Holland, 3584 CX
        • Rekruttering
        • Universitair Medisch Centrum Utrecht
        • Kontakt:
  • Israel
      • Ashkelon, Israel, 78278
        • Rekruttering
        • The Barzilai University Medical Center
        • Kontakt:
      • Jerusalem, Israel, 9112001
        • Rekruttering
        • Hadassah Medical Center- Ein Kerem
        • Kontakt:
      • Tel HaShomer, Israel, 52621
  • Italien
      • Bologna, Italien, 40139
        • Rekruttering
        • AUSL di Bologna - Ospedale Bellaria
        • Kontakt:
      • Pavia, Italien, 27100
        • Rekruttering
        • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
        • Kontakt:
      • Roma, Italien, 133
        • Rekruttering
        • Fondazione PTV Policlinico Tor Vergata
        • Kontakt:
      • Roma, Italien, 161
        • Rekruttering
        • Azienda Ospedaliero-Universitaria Policlinico Umberto I
        • Kontakt:
      • Roma, Italien, 00189
      • Rozzano, Italien, 20089
        • Rekruttering
        • IRCCS Istituto Clinico Humanitas
        • Kontakt:
          • Pietro Emiliano Doneddu, MD
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italien, 40139
        • Rekruttering
        • AUSL di Bologna - Ospedale Bellaria
        • Kontakt:
  • Japan
      • Aomori, Japan, 030-8553
      • Bunkyō City, Japan, 113-8431
        • Rekruttering
        • Juntendo University Hospital
        • Kontakt:
      • Chūōku, Japan, 260-8677
        • Rekruttering
        • Chiba University Hospital
        • Kontakt:
      • Hiroshima, Japan, 430-8558
        • Rekruttering
        • Seirei Hamamatsu Hospital
        • Kontakt:
      • Izunokuni, Japan, 410-2295
        • Rekruttering
        • Juntendo Shizuoka University Hospital
        • Kontakt:
      • Osaka, Japan, 545-8586
        • Rekruttering
        • Osaka Metropolitan University Hospital
        • Kontakt:
      • Saga, Japan, 849-8501
        • Rekruttering
        • Saga University Hospital
        • Kontakt:
      • Shimotsuke, Japan, 329-0498
        • Rekruttering
        • Jichi Medical University Hospital
        • Kontakt:
      • Tsuchiura, Japan, 300-0028
        • Rekruttering
        • General Hospital Tsuchiura Kyodo Hospital
        • Kontakt:
      • Ube, Japan, 755-0067
  • Norge
      • Oslo, Norge, 450
        • Rekruttering
        • Oslo Universitetssykehus HF, Ullevål
        • Kontakt:
  • Polen
      • Bydgoszcz, Polen, 85-065
        • Rekruttering
        • MICS Centrum Medyczne Bydgoszcz
        • Kontakt:
      • Bydgoszcz, Polen, 85-796
        • Rekruttering
        • Neurocentrum Bydgoszcz
        • Kontakt:
      • Katowice, Polen, 40-689
      • Krakow, Polen, 30-721
        • Rekruttering
        • Centrum Medyczne Linden
        • Kontakt:
      • Krakow, Polen, 30-688
        • Rekruttering
        • SP ZOZ Szpital Uniwersytecki w Krakowie
        • Kontakt:
      • Lublin, Polen, 20-064
        • Rekruttering
        • Galen Clinic - Lublin
        • Kontakt:
      • Poznan, Polen, 61-731
        • Rekruttering
        • Clinical Research Center Sp. z o.o. Medic-R sp.k.
        • Kontakt:
      • Rzeszów, Polen, 35-210
        • Rekruttering
        • Centrum Medyczne Medyk
        • Kontakt:
      • Rzeszów, Polen, 35-210
        • Rekruttering
        • Centrum Medyczne Medyk-al. Tadeusza Rejtana 53
        • Kontakt:
      • Szczecin, Polen, 71-252
        • Rekruttering
        • Uniwersytecki Szpital Kliniczny Nr 1
        • Kontakt:
      • Szczecin, Polen, 71-252
        • Rekruttering
        • Uniwersytecki Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie
        • Kontakt:
      • Warsaw, Polen, 02-097
        • Rekruttering
        • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
        • Kontakt:
  • Portugal
      • Porto, Portugal, 4050-342
        • Rekruttering
        • ULS de Santo António, EPE - Hospital de Santo António
        • Kontakt:
  • Rumænien
      • Bucharest, Rumænien, 41914
        • Rekruttering
        • Institutul National de Neurologie si Boli Neurovasculare Bucuresti
        • Kontakt:
      • Constanța, Rumænien, 900348
        • Rekruttering
        • Brainaxy Clinic SRL
        • Kontakt:
      • Târgu Mureş, Rumænien, 540136
        • Rekruttering
        • Targu-Mures Emergency Clinical County Hospital
        • Kontakt:
    • Bucharest
      • Bucharest, Bucharest, Rumænien, 41914
        • Rekruttering
        • Institutul National de Neurologie si Boli Neuroavasculare Bucuresti
        • Kontakt:
  • Schweiz
      • Geneva, Schweiz, 1205
        • Rekruttering
        • Hôpitaux Universitaires de Genève (HUG)
        • Kontakt:
  • Serbien
      • Belgrade, Serbien, 11000
        • Rekruttering
        • University Clinical Center of Serbia - Dr Subotica 6
        • Kontakt:
      • Niš, Serbien, 18 000
        • Rekruttering
        • University Clinical Center Nis
        • Kontakt:
  • Singapore
      • Singapore, Singapore, 308433
  • Slovakiet
      • Martin, Slovakiet, 036 59
        • Rekruttering
        • Univerzitna nemocnica MARTIN
        • Kontakt:
  • Slovenien
      • Ljubljana, Slovenien, 1000
        • Rekruttering
        • University Medical Centre Ljubljana
        • Kontakt:
      • Maribor, Slovenien, 2000
        • Rekruttering
        • University Clinical Centre Maribor
        • Kontakt:
  • Spanien
      • Barcelona, Spanien, 08041
        • Rekruttering
        • Hospital de La Santa Creu i Sant Pau
        • Kontakt:
      • Madrid, Spanien, 28007
        • Rekruttering
        • Hospital General Universitario Gregorio Marañon
        • Kontakt:
      • Sant Andreu de la Barca, Spanien, 08740
        • Rekruttering
        • Hospital Universitario Vall d'Hebron
        • Kontakt:
      • Seville, Spanien, 41009
        • Rekruttering
        • Hospital Universitario Virgen Macarena
        • Kontakt:
  • Sverige
      • Gothenburg, Sverige, 41346
        • Rekruttering
        • Sahlgrenska University Hospital
        • Kontakt:
  • Sydkorea
      • Busan, Sydkorea, 48108
        • Rekruttering
        • Inje University Haeundae Paik Hospital
        • Kontakt:
      • Seoul, Sydkorea, 03080
        • Rekruttering
        • Seoul National University Hospital
        • Kontakt:
      • Seoul, Sydkorea, 05030
        • Rekruttering
        • Konkuk University Medical Center
        • Kontakt:
      • Seoul, Sydkorea, 03722
        • Rekruttering
        • Severance Hospital Yonsei University Health System
        • Kontakt:
  • Tjekkiet
      • Brno, Tjekkiet
        • Rekruttering
        • Fakultni nemocnice Brno
        • Kontakt:
  • Tyrkiet (Türkiye)
      • Istanbul, Tyrkiet (Türkiye), 34083
        • Rekruttering
        • Istanbul Tip Fakultesi Hastanesi (Istanbul Universitesi)
        • Kontakt:
      • Samsun, Tyrkiet (Türkiye), 55200
        • Rekruttering
        • Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
        • Kontakt:
  • Tyskland
      • Berlin, Tyskland, 13353
        • Rekruttering
        • Charité - Universitätsmedizin Berlin
        • Kontakt:
      • Kiel, Tyskland, 24105
        • Rekruttering
        • Universitätsklinikum Schleswig-Holstein - Campus Kiel
        • Kontakt:
  • Ungarn
      • Budapest, Ungarn, 1085
        • Rekruttering
        • Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete
        • Kontakt:
  • Østrig
      • Linz, Østrig
        • Rekruttering
        • Kepler Universitätsklinikum Linz - Med Campus III
        • Kontakt:
      • Vienna, Østrig, 1090
        • Rekruttering
        • Universitätsklinikum AKH Wien
        • 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:

  • Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
  • Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
  • Has responded to IVIg in the past 5 years
  • Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg
  • Has residual disability and active disease

Exclusion Criteria:

  • Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk, including polyneuropathy of other causes
  • Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
  • Use of other long-acting immunomodulatory treatment

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Part A - empasiprubart + IVIg-placebo

During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm.
Andet: IVIg-placebo

A placebo resembling the IVIg treatment

Biologisk: empasiprubart

Intravenous infusion of empasiprubart
Aktiv komparator: Part A - IVIg + empasiprubart-placebo

During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm.
Biologisk: IVIg

Intravenous infusion of IVIg

Andet: empasiprubart-placebo

A placebo resembling the empasiprubart treatment
Eksperimentel: Part B - empasiprubart

After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg). Participants from the empasiprubart + IVIg- placebo arm in Part A will receive empasiprubart placebo once to maintain the blind of Part A.
Biologisk: empasiprubart

Intravenous infusion of empasiprubart

Andet: empasiprubart-placebo

A placebo resembling the empasiprubart treatment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reduction of ≥1 point compared with baseline in aINCAT score at week 24
Tidsramme: up to 24 weeks

The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).
up to 24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af planlagte timer, der er tabt i alt (fravær+ præsentation
Tidsramme: Op til 24 uger
Op til 24 uger
Forekomst af antidrug antistoffer mod empasiprubart i serum
Tidsramme: Op til 24 uger (del A) + 96 uger (del B)
Op til 24 uger (del A) + 96 uger (del B)
Forekomst af neutraliserende antistoffer mod empasiprubart i serum
Tidsramme: Op til 24 uger (del A) + 96 uger (del B)
Op til 24 uger (del A) + 96 uger (del B)
Forekomst af (alvorlige) bivirkninger
Tidsramme: Op til 24 uger (del A) + 96 uger (del B)
Op til 24 uger (del A) + 96 uger (del B)
Procentdelændring fra baseline i gratis C2 og total C2 over tid
Tidsramme: Op til 24 uger (del A) + 96 uger (del B)
Op til 24 uger (del A) + 96 uger (del B)
Serumkoncentrationer af empasiprubart over tid
Tidsramme: Op til 24 uger (del A) + 96 uger (del B)
Op til 24 uger (del A) + 96 uger (del B)
Change from baseline in I-RODS centile points score at week 24
Tidsramme: up to 24 weeks

Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome).
up to 24 weeks
Change from baseline in MRC-SS at week 24
Tidsramme: up to 24 weeks

The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome).
up to 24 weeks
Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24
Tidsramme: up to 24 weeks

The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. The 3-day moving average will be generated based on the average of the obtained averages for each hand on the target day and the preceding 2 days.
up to 24 weeks
Time to reduction of ≥1 point from baseline in aINCAT score
Tidsramme: up to 24 weeks

The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).
up to 24 weeks
Change from baseline in TUG at week 24
Tidsramme: up to 24 weeks

The Timed Up and Go Test (TUG) is a simple test to assess a person's mobility in which the time expended to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is measured.
up to 24 weeks
Time to increase of ≥1 point compared with baseline in aINCAT score
Tidsramme: Up to 24 weeks

The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).
Up to 24 weeks
Change from baseline in grip strength (3-day moving average) of both hands over time
Tidsramme: up to 24 weeks + 96 weeks (Part B)

The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. The 3-day moving average will be generated based on the average of the obtained averages for each hand on the target day and the preceding 2 days.
up to 24 weeks + 96 weeks (Part B)
Change from baseline in grip strength (daily average) for both hands
Tidsramme: up to 24 weeks + 96 weeks (Part B)

The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. A daily average will be generated based on the average of the obtained averages for each hand.
up to 24 weeks + 96 weeks (Part B)
Change from baseline in MRC-SS over time
Tidsramme: up to 96 weeks (Part B)

The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome).
up to 96 weeks (Part B)
Change from baseline in aINCAT over time
Tidsramme: up to 24 weeks (Part A) + 96 weeks (Part B)

The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).
up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in EQ-5D-5L over time
Tidsramme: up to 24 weeks (Part A) + 96 weeks (Part B)

EQ-5D-5L questionnaire is a patient-reported outcome measure, ranging 0 to 100 (lower score, worse outcome).
up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in RT-FSS over time
Tidsramme: up to 24 weeks (Part A) + 96 weeks (Part B)

Rasch-Transformed Fatigue Severity Scale (RT-FSS) is a patient-reported outcome measure to distinguish fatigue from clinical depression.
up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in SF-12 over time
Tidsramme: up to 24 weeks (Part A) + 96 weeks (Part B)

12-Item Short Form Health Survey (SF-12) is a general patient-reported outcome measure.
up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in BPI-SF over time
Tidsramme: up to 24 weeks (Part A) + 96 weeks (Part B)

The Brief Pain Inventory-Short Form (BPI-SF) is a patient-reported outcome measure to assess pain severity and pain interference.
up to 24 weeks (Part A) + 96 weeks (Part B)
PGI-S values over time
Tidsramme: up to 24 weeks (Part A) + 96 weeks (Part B)

The Patient Global Impression of Severity (PGI-S) is a patient-reported outcome measure that reflects the patient's belief about the severity of the illness.
up to 24 weeks (Part A) + 96 weeks (Part B)
PGI-C values over time
Tidsramme: up to 24 weeks (Part A) + 96 weeks (Part B)

The Patient Global Impression of Change (PGI-C) is a patient- reported outcome measure that reflects the patient's belief about the efficacy of treatment.
up to 24 weeks (Part A) + 96 weeks (Part B)
Values for work-related and household chore activities of the HRPQ
Tidsramme: up to 24 weeks

The Health-Related Productivity Questionnaire (HRPQ) assesses health-related and work-related productivity, with questions related to 'hours lost because of absenteeism'.
up to 24 weeks
Change from baseline in I-RODS centile points score over time
Tidsramme: Up to 96 weeks (Part B)

Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome).
Up to 96 weeks (Part B)
Change from baseline in TUG over time
Tidsramme: Up to 96 weeks (Part B)

The Timed Up and Go Test (TUG) is a simple test to assess a person's mobility in which the time expended to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is measured.
Up to 96 weeks (Part B)

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)

22. august 2025

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

1. september 2030

Datoer for studieregistrering

Først indsendt

26. marts 2025

Først indsendt, der opfyldte QC-kriterier

2. april 2025

Først opslået (Faktiske)

9. april 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ARGX-117-2401
  • 2024-520097-36-00 (Ctis)

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 .

Abonner