Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-1)

8. september 2026 opdateret af: GlaxoSmithKline

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants 40 to 80 Years of Age With Moderate to Very Severe COPD (PERSIST COPD-1)

The study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to placebo in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

624

Fase

  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Florida
      • Doral, Florida, Forenede Stater, 33172
        • Rekruttering
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Alan Kaufman
    • Louisiana
      • Lake Charles, Louisiana, Forenede Stater, 70605
        • Rekruttering
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Jason Langhofer

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Male or eligible female participants
  • Participants with >=40 to less than or equal to (<=) 80 years of age.
  • An eosinophilic phenotype with elevated BEC.
  • Moderate to very severe COPD with frequent exacerbations.
  • Participants with elevated COPD assessment test (CAT) score.
  • Current or former cigarette smokers.
  • On triple (Inhaled corticosteroid [ICS]+ Long-acting muscarinic antagonist [LAMA]+ Long-acting beta-agonist [LABA]) or dual inhaled COPD therapy, if ICS is considered not appropriate.

Exclusion Criteria:

  • Current or prior physician diagnosis of asthma
  • Other clinically significant lung disease.
  • Pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.
  • Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure.
  • Continuous oxygen therapy (more than 16 hours/ day).
  • Cor pulmonale resulting in right heart failure and severe pulmonary hypertension.
  • A current malignancy or history of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix).
  • Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia.
  • New York Heart Association class III or IV heart failure.
  • Other significant medical conditions that could impact participants' safety or study outcomes.

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: Participants receiving GSK5784283 plus standard of care
Medicin: GSK5784283
GSK5784283 vil blive administreret.
Medicin: Standard of care
Standard of care will be administered.
Placebo komparator: Participants receiving matching placebo plus standard of care
Medicin: Placebo
Placebo vil blive givet.
Medicin: Standard of care
Standard of care will be administered.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Annualized rate of moderate or severe COPD Exacerbations
Tidsramme: Up to Week 78
Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (that is greater than or equal to [>=] 24 hours) or result in death.
Up to Week 78

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in St. George's respiratory questionnaire (SGRQ) total score
Tidsramme: Baseline (Day 1) and up to Week 52
SGRQ total score will be measured using the SGRQ for COPD (SGRQ-C). The SGRQ-C is a 14-item participant questionnaire, designed to measure health impairment by addressing the frequency of respiratory symptoms (questions 1-7) and the participant's current state (questions 8-14). The total score will be calculated on 0-100 rating scale and scores expressed as a percentage of overall impairment. Higher scores indicate greater impairment of health.
Baseline (Day 1) and up to Week 52
Change from Baseline in pre-Bronchodilator Forced expiratory volume in 1 second (FEV1)
Tidsramme: Baseline (Day 1) and at Week 52
FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometry.
Baseline (Day 1) and at Week 52
Annualized rate of COPD exacerbations requiring emergency department (ED) visit or hospitalization
Tidsramme: Up to Week 78
Annualized rate of COPD exacerbations requiring ED visit or hospitalization (For pooled analysis across studies 300629 and 300631) will be assessed.
Up to Week 78
Annualized rate of moderate/severe COPD exacerbations among participants with elevated screening blood eosinophil counts (BEC)
Tidsramme: Up to Week 78
Annualized rate of moderate/severe COPD exacerbations among participants with elevated screening BEC (For pooled analysis across studies 300629 and 300631) will be assessed.
Up to Week 78
Time to first moderate or severe COPD exacerbation
Tidsramme: Up to Week 78
Time to first moderate or severe exacerbation (For pooled analysis across studies 300629 and 300631) will be assessed.
Up to Week 78

Samarbejdspartnere og efterforskere

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

Sponsor

GlaxoSmithKline

Efterforskere

  • Studieleder: GSK Clinical Trials, GlaxoSmithKline

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)

27. august 2026

Primær færdiggørelse (Anslået)

20. juli 2029

Studieafslutning (Anslået)

15. marts 2030

Datoer for studieregistrering

Først indsendt

19. august 2026

Først indsendt, der opfyldte QC-kriterier

19. august 2026

Først opslået (Faktiske)

21. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 300629
  • 2026-526969-17 (Registry Identifier: EU CT Number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

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.

IPD-delingsadgangskriterier

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 Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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