RecruitingPhase 3

A Study of Depemokimab in Participants of 6 to 11 Years of Age

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 11 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests depemokimab as an added asthma medicine for children ages 6 to 11 with type 2 inflammation, a type of swelling linked to the immune system. It checks how the body processes the medicine, how it works, and how safe and well tolerated it is.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 6 to 11 and weigh at least 15 kilograms (about 33 pounds).
  • Have a doctor's diagnosis of asthma for at least 12 months that meets accepted asthma guidelines.
  • Have high levels of eosinophils, a type of white blood cell: at least 300 cells per microliter in the past 12 months, or at least 150 at the first visit.
  • Have needed a medium- or high-dose inhaled steroid regularly for the past 12 months, with or without regular steroid pills.
  • Have used another daily asthma control medicine for at least 3 months before screening. In Japan, this is not needed if the inhaled steroid dose is high.
  • Have had at least 2 asthma flare-ups in the past 12 months that needed steroid pills or injections despite inhaled steroids. For children already taking regular steroid pills, the dose must have at least doubled for each flare-up.
  • Girls must not be pregnant. They must not have reached puberty, must not be sexually active, or must use accepted birth control during treatment and for at least 35 weeks after the last dose.
  • Complete the required consent process, with the child's agreement when needed. A legal guardian or main caregiver must help with follow-up, attend study visits, and provide information.

Who can't join

  • Have ever had life-threatening asthma, have another serious lung disease, have a weak immune system, or take medicines that suppress it other than oral steroids for asthma.
  • Have another cause of high eosinophils, blood vessel inflammation called vasculitis, or another important health condition that could affect the study.
  • Have received an antibody medicine within 130 days before the first visit, or longer if it stays in the body longer. Approved COVID-19 treatments are allowed. A past documented failure of an IL-5 or IL-5 receptor treatment also rules out joining.
  • Have used a study drug within 30 days before the first visit, or longer if it stays in the body longer; used an experimental non-biologic anti-inflammatory drug within 3 months; or are in another clinical trial.
  • Have had a known parasite infection within 6 months before the first visit.
  • Have an allergy or intolerance to antibody or biologic medicines, or to an ingredient in the study medicine.
  • Have a known history of not taking asthma control medicines as directed or not being able to follow the doctor's advice.
  • Have certain abnormal liver blood tests, serious liver or bile duct disease, or a heart tracing test (ECG) showing a serious problem or certain prolonged heartbeat timing.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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, 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

Study sites (3)

AL

CO

SD