- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07671001
A Study of Depemokimab in Participants of 6 to 11 Years of Age (GLIDE)
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
Aperçu de l'étude
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: US GSK Clinical Trials Call Center
- Numéro de téléphone: 877-379-3718
- E-mail: GSKClinicalSupportHD@gsk.com
Sauvegarde des contacts de l'étude
- Nom: EU GSK Clinical Trials Call Center
- Numéro de téléphone: +44 (0) 20 89904466
- E-mail: GSKClinicalSupportHD@gsk.com
Lieux d'étude
-
-
Alabama
-
Mobile, Alabama, États-Unis, 36608
- Recrutement
- GSK Investigational Site
-
Contact:
- US GSK Clinical Trials Call Center
- Numéro de téléphone: 877-379-3718
- E-mail: GSKClinicalSupportHD@gsk.com
-
Contact:
- EU GSK Clinical Trials Call Centre
- Numéro de téléphone: +44 (0) 20 8990 4466
- E-mail: GSKClinicalSupportHD@gsk.com
-
Chercheur principal:
- Lawrence Sindel
-
-
Colorado
-
Colorado Springs, Colorado, États-Unis, 80923
- Recrutement
- GSK Investigational Site
-
Contact:
- US GSK Clinical Trials Call Center
- Numéro de téléphone: 877-379-3718
- E-mail: GSKClinicalSupportHD@gsk.com
-
Contact:
- EU GSK Clinical Trials Call Centre
- Numéro de téléphone: +44 (0) 20 8990 4466
- E-mail: GSKClinicalSupportHD@gsk.com
-
Chercheur principal:
- Eric Caplan
-
-
South Dakota
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Watertown, South Dakota, États-Unis, 13601
- Recrutement
- GSK Investigational Site
-
Contact:
- US GSK Clinical Trials Call Center
- Numéro de téléphone: 877-379-3718
- E-mail: GSKClinicalSupportHD@gsk.com
-
Contact:
- EU GSK Clinical Trials Call Centre
- Numéro de téléphone: +44 (0) 20 8990 4466
- E-mail: GSKClinicalSupportHD@gsk.com
-
Chercheur principal:
- Dariusz Chrostowski
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Depemokimab
Participants will receive depemokimab at doses based on their body weight.
|
Depemokimab sera administré.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Depemokimab Concentration in Plasma
Délai: Up to Week 52
|
Up to Week 52
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Number of Participants with Adverse events (AE) and Serious Adverse Events (SAE)
Délai: Up to Week 52
|
Up to Week 52
|
|
Number of Participants with Clinically Significant changes in Clinical Safety Laboratory Parameters
Délai: Up to Week 52
|
Up to Week 52
|
|
Number of Participants with Clinically Significant Changes in Vital Signs
Délai: Up to Week 52
|
Up to Week 52
|
|
Number of Participants with Positive Anti-Depemokimab Binding Antibodies and Neutralizing Antibodies
Délai: Up to Week 52
|
Up to Week 52
|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Délai: Up to Week 52
|
Up to Week 52
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: GSK Clinical Trials, GlaxoSmithKline
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système immunitaire
- Maladies des voies respiratoires
- Maladies pulmonaires
- Maladies bronchiques
- Maladies pulmonaires obstructives
- Hypersensibilité respiratoire
- Hypersensibilité immédiate
- Hypersensibilité
- Syndrome hyperéosinophile
- Éosinophilie
- Troubles leucocytaires
- Maladies hématologiques
- Maladies hémiques et lymphatiques
- Asthme
- Éosinophilie pulmonaire
Autres numéros d'identification d'étude
- 213204
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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