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

GlaxoSmithKline

Summary

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.

Eligibility

Age range: 6–11 years
Sex: All
Healthy volunteers: No

Detailed criteria

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,…

Interventions

Biological
Depemokimab
Depemokimab will be administered.

Locations (3)

GSK Investigational Site
Mobile, Alabama
GSKClinicalSupportHD@gsk.com 877-379-3718
GSK Investigational Site
Colorado Springs, Colorado
GSKClinicalSupportHD@gsk.com 877-379-3718
GSK Investigational Site
Watertown, South Dakota
GSKClinicalSupportHD@gsk.com 877-379-3718

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

Summary

Eligibility

Interventions

Locations (3)

Compensation

Run this study?

Details

Conditions