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

NCT07671001 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 213204
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Asthma

Keywords

Depemokimab; GSK3511294; Asthma with Type 2 Inflammation; Pediatric Asthma; Eosinophilic Asthma; Eosinophilic phenotype

Outcome Measures

Primary Outcomes (1)

• Depemokimab Concentration in Plasma

  Up to Week 52

Secondary Outcomes (5)

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

  Up to Week 52

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

  Up to Week 52

• Number of Participants with Clinically Significant Changes in Vital Signs

  Up to Week 52

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

  Up to Week 52

• Ratio to Baseline in Absolute Blood Eosinophil Count

  Up to Week 52

Study Arms (1)

Depemokimab

EXPERIMENTAL

Participants will receive depemokimab at doses based on their body weight.

Biological: Depemokimab

Interventions

Depemokimab BIOLOGICAL

Depemokimab will be administered.

Also known as: GSK3511294

Depemokimab

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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
• 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, 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

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
• 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
• Alanine aminotransferase (ALT) greater than (\>)2 \* Upper limit of normal (ULN)

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Asthma; Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): March 19, 2029
• Study Completion (Estimated): March 19, 2029
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.