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 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
624
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: US GSK Clinical Trials Call Center
- Telefonnummer: 877-379-3718
- E-post: GSKClinicalSupportHD@gsk.com
Studera Kontakt Backup
- Namn: EU GSK Clinical Trials Call Center
- Telefonnummer: +44 (0) 20 89904466
- E-post: GSKClinicalSupportHD@gsk.com
Studieorter
-
-
Florida
-
Doral, Florida, Förenta staterna, 33172
- Rekrytering
- GSK Investigational Site
-
Kontakt:
- US GSK Clinical Trials Call Center
- Telefonnummer: 877-379-3718
- E-post: GSKClinicalSupportHD@gsk.com
-
Kontakt:
- EU GSK Clinical Trials Call Centre
- Telefonnummer: +44 (0) 20 8990 4466
- E-post: GSKClinicalSupportHD@gsk.com
-
Huvudutredare:
- Alan Kaufman
-
-
Louisiana
-
Lake Charles, Louisiana, Förenta staterna, 70605
- Rekrytering
- GSK Investigational Site
-
Kontakt:
- US GSK Clinical Trials Call Center
- Telefonnummer: 877-379-3718
- E-post: GSKClinicalSupportHD@gsk.com
-
Kontakt:
- EU GSK Clinical Trials Call Centre
- Telefonnummer: +44 (0) 20 8990 4466
- E-post: GSKClinicalSupportHD@gsk.com
-
Huvudutredare:
- Jason Langhofer
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Participants receiving GSK5784283 plus standard of care
|
GSK5784283 kommer att administreras.
Standard of care will be administered.
|
|
Placebo-jämförare: Participants receiving matching placebo plus standard of care
|
Placebo kommer att ges.
Standard of care will be administered.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Annualized rate of moderate or severe COPD Exacerbations
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline in St. George's respiratory questionnaire (SGRQ) total score
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: GSK Clinical Trials, GlaxoSmithKline
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
27 augusti 2026
Primärt slutförande (Beräknad)
20 juli 2029
Avslutad studie (Beräknad)
15 mars 2030
Studieregistreringsdatum
Först inskickad
19 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
19 augusti 2026
Första postat (Faktisk)
21 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Luftvägssjukdomar
- Lungsjukdomar
- Lungsjukdomar, obstruktiv
- Patologiska tillstånd, tecken och symtom
- Lungsjukdom, kronisk obstruktiv
- Administration
- Sjukvårdskvalitet, tillgång och utvärdering
- Hälsovårdskvalitet
- Kvalitetsindikatorer, hälsovård
- Vårdstandard
Andra studie-ID-nummer
- 300629
- 2026-526969-17 (Registeridentifierare: EU CT Number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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