A Study of Depemokimab in Participants of 6 to 11 Years of Age
ConditionAsthma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-11
SponsorGlaxoSmithKline
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Depemokimab
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov