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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Depemokimab

    Biological/Vaccine

    Depemokimab will be administered.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: DepemokimabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Depemokimab Concentration in Plasma

Time frame
Up to Week 52

Secondary outcomes

1

Number of Participants with Adverse events (AE) and Serious Adverse Events (SAE)

Time frame
Up to Week 52
2

Number of Participants with Clinically Significant changes in Clinical Safety Laboratory Parameters

Time frame
Up to Week 52
3

Number of Participants with Clinically Significant Changes in Vital Signs

Time frame
Up to Week 52
4

Number of Participants with Positive Anti-Depemokimab Binding Antibodies and Neutralizing Antibodies

Time frame
Up to Week 52

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: