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A Study of Depemokimab in Participants of 6 to 11 Years of Age (GLIDE)

25. srpna 2026 aktualizováno: GlaxoSmithKline

A Phase 3, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Depemokimab (GSK3511294) Administered Subcutaneously as Add on Maintenance Treatment of Asthma With Type 2 Inflammation Characterised by an Eosinophilic Phenotype in Participants Aged 6 to 11 Years Old

This study is aimed at assessing depemokimab as an add-on medicine for the treatment of asthma with type-2 inflammation in participants of 6 to 11 years of age. This study will test how the body processes depemokimab, how the drug works in the body, and its safety and tolerability.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

34

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

    • Alabama
      • Mobile, Alabama, Spojené státy, 36608
        • Nábor
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Lawrence Sindel
    • Colorado
      • Colorado Springs, Colorado, Spojené státy, 80923
        • Nábor
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Eric Caplan
    • South Dakota
      • Watertown, South Dakota, Spojené státy, 13601
        • Nábor
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Dariusz Chrostowski

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Participants who have a documented physician diagnosis of asthma for at least 12 months prior to Visit 1 that meets the National Heart, Lung, and Blood Institute guidelines [NHLBI, 2007] or Global Initiative of Asthma (GINA) guidelines [GINA, 2025] or Japanese Pediatric Guidelines for The Treatment and Management of Asthma [JPGL, 2023]
  • Asthma with type 2 inflammation characterised by an eosinophilic phenotype as indicated by: elevated peripheral blood eosinophil count of greater than or equal to (>=)300 cells/microliters (mcL) demonstrated in the past 12 months, or elevated peripheral blood eosinophil count of >=150 cells/ mcL at visit 1
  • Participants who are >=15 Kilograms (kg) in body weight
  • A well-documented requirement for regular treatment with inhaled corticosteroid (>=200 mcg/day fluticasone propionate (DPI) or equivalent daily) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS). The Inhaled corticosteroids (ICS) dose should represent medium or high dose in children aged 6-11 years of age
  • Current treatment with an additional controller medication for at least 3 months prior to screening [e.g., long-acting beta-2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline]. For Japan only: This inclusion criterion does not apply to the participants in Japan. As long as the ICS dose represent high dose, the current treatment or previous failure of an additional controller will not be required for eligibility
  • Previously confirmed history of at least two asthma exacerbations requiring treatment with systemic corticosteroids (CS) (intramuscular [IM], intravenous, or oral), in the 12 months prior to visit 1, despite the use of ICS. For participants receiving maintenance OCS, treatment for the exacerbations must have been a two-fold increase or greater in the CS dose
  • Male or eligible female
  • A female participant is eligible to participate if she is not pregnant, and one of the following conditions applies: Is prepuberal or having periods but no sexual activity or using an acceptable contraceptive method, if sexual activity. prior to and during the study intervention period (at a minimum until 35 weeks after the last dose of study intervention).
  • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a girl with an early undetected pregnancy
  • The investigator, or a person designated by the investigator, will obtain written informed consent from each study participant and the participant's assent, when applicable, before any study-specific activity is performed unless a waiver of informed consent has been granted by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC). All legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand
  • A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow-up; accompany the participant to the study site on each assessment day according to the Schedule of activities (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant, as needed

Exclusion Criteria:

  • Participants with any history of life-threatening asthma (e.g. requiring intubation and assisted ventilation), immunosuppressive medications intake with the exception of oral CS for asthma, or immunodeficiency disorder
  • Or presence of a known pre-existing, clinically important lung condition other than asthma
  • Participants with other conditions that could lead to elevated eosinophils
  • Participants who have known, pre-existing, clinically significant medical conditions that could affect the conduct of the study
  • Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis excluded prior to enrolment
  • Participants who have received mepolizumab (Nucala), reslizumab (Cinqair/Cinqaero) or benralizumab (Fasenra) within 130 days or 5-half-lives (whichever is longer) prior to Visit 1 or who have previous documented failure with anti- Interleukin-5 Receptor (IL5/5R) therapy
  • Participants who have received omalizumab (e.g., Xolair, Omlyclo), tezepelumab (Tezspire) or dupilumab (Dupixent) within 130 days or 5-half-lives (whichever is longer) prior to Visit 1
  • Participants who have received any monoclonal Antibody (mAb) within 130 days or 5-half-lives (whichever is longer) of Visit 1. Authorised treatments for Coronavirus disease 2019 (COVID-19) are permitted and should be used in line with local regulatory guidance
  • Participants who have received treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to Visit 1 (this also includes investigational formulations of marketed products)
  • Participants who have received treatment with an experimental anti-inflammatory drug (non-biologicals) within 3 months prior to Visit 1
  • Concurrent enrollment in another clinical trial
  • Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1
  • Participants with allergy/intolerance to a mAb or biologic or any of the excipients of the investigational products
  • Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations
  • Liver safety exclusion criteria: Participants who meet the following criteria based on results from the sample taken at Screening Visit

    • Alanine aminotransferase (ALT) greater than (>)2 * Upper limit of normal (ULN)
    • Total bilirubin >1.5 * ULN; for participants with Gilbert's syndrome can be included with total bilirubin >1.5xULN as long as direct bilirubin is less than or equal to (=<) 1.5 * ULN
    • Cirrhosis or current liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice
  • An abnormal Electrocardiogram (ECG) finding from the 12-lead ECG conducted at Screening, if considered clinically significant and likely to impact the participant's study participation, based on the evaluation of both the investigator and a pediatric cardiologist, or measured results of QT Corrected for Heart Rate using Fridericia's Formula (QTcF)

    • >460 milliseconds (msec)
    • >480 msec for participants with bundle branch block

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Depemokimab
Participants will receive depemokimab at doses based on their body weight.
Depemokimab bude podáván.
Ostatní jména:
  • GSK3511294

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
Depemokimab Concentration in Plasma
Časové okno: Up to Week 52
Up to Week 52

Sekundární výstupní opatření

Měření výsledku
Časové okno
Number of Participants with Adverse events (AE) and Serious Adverse Events (SAE)
Časové okno: Up to Week 52
Up to Week 52
Number of Participants with Clinically Significant changes in Clinical Safety Laboratory Parameters
Časové okno: Up to Week 52
Up to Week 52
Number of Participants with Clinically Significant Changes in Vital Signs
Časové okno: Up to Week 52
Up to Week 52
Number of Participants with Positive Anti-Depemokimab Binding Antibodies and Neutralizing Antibodies
Časové okno: Up to Week 52
Up to Week 52
Ratio to Baseline in Absolute Blood Eosinophil Count
Časové okno: Up to Week 52
Up to Week 52

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Vyšetřovatelé

  • Ředitel studie: GSK Clinical Trials, GlaxoSmithKline

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

25. června 2026

Primární dokončení (Odhadovaný)

1. března 2027

Dokončení studie (Odhadovaný)

24. listopadu 2028

Termíny zápisu do studia

První předloženo

22. června 2026

První předloženo, které splnilo kritéria kontroly kvality

22. června 2026

První zveřejněno (Aktuální)

26. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 213204

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Časový rámec sdílení IPD

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 asset(s) with development terminated across all indications.

Kritéria přístupu pro sdílení IPD

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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .