RecruitingAsthma
A Study of Depemokimab in Participants of 6 to 11 Years of Age
Eligible age
6–11 yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: GlaxoSmithKline
You may qualify if…
- ✓ 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).
You may not qualify if…
- ✕ 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT07671001 · last updated 2026-08-26