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REIMAGINE - Real World Evaluation of Mepolizumab in Alvorlig Astma som oppnår ved behandling klinisk remisjon, en prospektiv studie (REIMAGINE)

6. november 2026 oppdatert av: GlaxoSmithKline

En prospektiv, virkelig verdens intervensjonsstudie for å evaluere effekten av mepolizumab på å oppnå klinisk remisjon hos deltakere med alvorlig astma

This is a prospective, real-world, single arm, global, multi-centre study to evaluate the effect of timely treatment with mepolizumab (NUCALA) to achieve clinical remission in adult participants with severe asthma with an eosinophilic phenotype (SA-EP).

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

177

Fase

  • Fase 4

Kontakter og plasseringer

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

Studiesteder

  • Belgia
      • Kortrijk, Belgia, 8500
        • GSK Investigational Site
      • Liège, Belgia, 4000
        • GSK Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B0M3
        • GSK Investigational Site
      • Calgary, Alberta, Canada
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3L 1Z5
        • GSK Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 1E2
        • GSK Investigational Site
  • Forente stater
    • California
      • La Jolla, California, Forente stater, 92037
        • GSK Investigational Site
      • Newport Beach, California, Forente stater, 92663
        • GSK Investigational Site
    • Colorado
      • Aurora, Colorado, Forente stater, 71105
        • GSK Investigational Site
      • Colorado Springs, Colorado, Forente stater, 80923
        • GSK Investigational Site
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06510
        • GSK Investigational Site
    • Florida
      • Homestead, Florida, Forente stater, 33032-8185
        • GSK Investigational Site
      • Jacksonville, Florida, Forente stater, 32209
        • GSK Investigational Site
      • Miami, Florida, Forente stater, 33125
        • GSK Investigational Site
      • Plantation, Florida, Forente stater, 33317
        • GSK Investigational Site
    • Georgia
      • Adairsville, Georgia, Forente stater, 30103
        • GSK Investigational Site
      • Columbus, Georgia, Forente stater, 31904
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40509-1801
        • GSK Investigational Site
      • Owensboro, Kentucky, Forente stater, 42301
        • GSK Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 34452
        • GSK Investigational Site
    • Maryland
      • Glenn Dale, Maryland, Forente stater, 20769
        • GSK Investigational Site
      • Towson, Maryland, Forente stater, 21204
        • GSK Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48103
        • GSK Investigational Site
    • Minnesota
      • Linwood, Minnesota, Forente stater, 55092
        • GSK Investigational Site
      • Rochester, Minnesota, Forente stater, 55905-0001
        • GSK Investigational Site
    • Nevada
      • Henderson, Nevada, Forente stater, 89052-5015
        • GSK Investigational Site
    • New York
      • Rochester, New York, Forente stater, 14607
        • GSK Investigational Site
      • Schenectady, New York, Forente stater, 12308
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19140
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Forente stater, 19141
        • GSK Investigational Site
    • South Carolina
      • Union, South Carolina, Forente stater, 29379-7409
        • GSK Investigational Site
    • Texas
      • Cypress, Texas, Forente stater, 77429-1439
        • GSK Investigational Site
      • Kerrville, Texas, Forente stater, 78028
        • GSK Investigational Site
      • McKinney, Texas, Forente stater, 75069
        • GSK Investigational Site
  • Frankrike
      • Brest, Frankrike, 29200
        • GSK Investigational Site
      • Cannes, Frankrike, 06614
        • GSK Investigational Site
      • Lille, Frankrike, 59000
        • GSK Investigational Site
      • Lyon, Frankrike, 69004
        • GSK Investigational Site
      • Strasbourg, Frankrike, 67091
        • GSK Investigational Site
      • Toulouse, Frankrike, 31059
        • GSK Investigational Site
  • Italia
      • Genova, Italia, 16132
        • GSK Investigational Site
      • Monserrato CA, Italia, 09042
        • GSK Investigational Site
      • Naples, Italia, 80131
        • GSK Investigational Site
      • Pieve Di Soligo TV, Italia, 131044
        • GSK Investigational Site
      • Roma, Italia, 00128
        • GSK Investigational Site
      • Roma, Italia, 161
        • GSK Investigational Site
      • Rozzano, Italia, 20089
        • GSK Investigational Site
      • Verona, Italia, 37126
        • GSK Investigational Site
  • Japan
      • Gifu, Japan, 509-6134
        • GSK Investigational Site
      • Kagawa, Japan, 760-0018
        • GSK Investigational Site
      • Tokyo, Japan, 142-8666
        • GSK Investigational Site
      • Tokyo, Japan, 173-8606
        • GSK Investigational Site
      • Tokyo, Japan, 105-0003
        • GSK Investigational Site
  • Polen
      • ?Od?, Polen, 90-153
        • GSK Investigational Site
      • Gdansk, Polen, 80-214
        • GSK Investigational Site
      • Lodz, Polen, 92-213
        • GSK Investigational Site
  • Spania
      • Barcelona, Spania, 08025
        • GSK Investigational Site
      • Girona, Spania, 17005
        • GSK Investigational Site
      • Valencia, Spania, 46015
        • GSK Investigational Site
  • Tyskland
      • Bonn, Tyskland, 53119
        • GSK Investigational Site
      • Hohenstein-Ernsttal, Tyskland, 9337
        • GSK Investigational Site
      • Schleswig, Tyskland, 53123
        • GSK Investigational Site
    • Hesse
      • Darmstadt, Hesse, Tyskland, 64283
        • GSK Investigational Site
      • Frankfurt am Main, Hesse, Tyskland, 60389
        • GSK Investigational Site
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Tyskland, 52074
        • GSK Investigational Site

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Participant has a confirmed asthma diagnosis and has been prescribed NUCALA by their physician for the treatment of asthma, as per local label. NUCALA can be initiated up to 7 days prior to study enrollment.
  • No NUCALA use in the 6 months prior to enrollment.
  • Participants with greater than or equal to (≥)60 percentage (%) predicted forced expiratory volume in 1 second (FEV1) and less than or equal to (≤)4 exacerbations per year, as confirmed by the physician.
  • Other local prescription criteria of NUCALA not described above at NUCALA initiation (e.g., local reimbursement criteria).
  • Written informed consent

Exclusion Criteria:

  • Investigator concerns about participant's willingness to adhere to biologic treatment for any reason (e.g., cost, behavior, difficulty with access to healthcare)
  • Participants currently on maintenance OCS or intramuscular corticosteroids.
  • Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment
  • Participants participating in an interventional study with a treatment intervention

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Group 1

Participants with a clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care.
Legemiddel: Mepolizumab

Mepolizumab will be prescribed based on physician decision.

Annen: Spirometry

Lung function via spirometry will be collected.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage (%) of Participants Achieving 4-Component Clinical Remission
Tidsramme: At month 12

4-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an Asthma Control Test (ACT) (d) No clinically significant deterioration of lung function.
At month 12

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits
Tidsramme: At month 12

CSE is defined as a deterioration in asthma requiring (1) the initiation of systemic corticosteroids and/or (2) an ER visit and/or hospital admission.
At month 12
Percentage of Participants Achieving OCS Sparing Remission
Tidsramme: At month 12

OCS sparing is defined as (a) No clinically significant asthma exacerbations during the period of interest (b) No OCS use for asthma at the time point of interest.
At month 12
Percentage of Participants Achieving 3-Component Clinical Remission
Tidsramme: At month 12

3-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an ACT
At month 12
Mean Change from Baseline in Mini-Asthma Quality of Life Questionnaire (AQLQ) Overall Score
Tidsramme: Baseline and at month 12

The mini-AQLQ overall score is a reduced version of the AQLQ which includes 15 items. The minimally clinically important difference (MCID) is 0.5. The response options for each item are on an equidistant scale of 7 points, where 1 corresponds to the maximum disability and 7 to the absence of disability
Baseline and at month 12

Samarbeidspartnere og etterforskere

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

Sponsor

GlaxoSmithKline

Etterforskere

  • Studieleder: GSK Clinical Trials, GlaxoSmithKline

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)

20. mars 2024

Primær fullføring (Faktiske)

12. februar 2026

Studiet fullført (Antatt)

31. mars 2027

Datoer for studieregistrering

Først innsendt

6. september 2023

Først innsendt som oppfylte QC-kriteriene

15. september 2023

Først lagt ut (Faktiske)

18. september 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 219871
  • 2023 (U.S. NIH-stipend/kontrakt)
  • 2023-509026-21-00 (Registeridentifikator: CTIS (EU))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD-delingstidsramme

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

Tilgangskriterier for IPD-deling

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere