Asthma study: Depemokimab
Official title A Study of Depemokimab in Participants of 6 to 11 Years of Age
ClinicalTrials.gov ID: NCT07671001
What this study is testing
What is Depemokimab?
Depemokimab is an investigational medicine, being studied as a potential treatment for asthma.
Also referred to as GSK3511294.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether depemokimab, added to usual asthma medicine, is safe and works in children 6 to 11 years old.
- Who it's for
- You may be able to join if you are 6 to 11 years old and have asthma with type‑2 inflammation.
- What's involved
- You would receive depemokimab injections along with your regular asthma medicine. You will have doctor visits and tests to see how your body handles the medicine.
- Time commitment
- The study lasts several months with visits at the start, during treatment, and later check‑ins.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 11
You may be able to join 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...
- Asthma with type 2 inflammation characterised by an eosinophilic phenotype as indicated by: elevated peripheral blood eosinophil count of greater...
- 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...
- Current treatment with an additional controller medication for at least 3 months prior to screening [e.g., long-acting beta-2-agonist (LABA)...
You likely can't join if
- Participants with any history of life-threatening asthma (e.g. requiring intubation and assisted ventilation), immunosuppressive medications intake...
- 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...
- Participants who have received mepolizumab (Nucala), reslizumab (Cinqair/Cinqaero) or benralizumab (Fasenra) within 130 days or 5-half-lives...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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].
- 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...
- 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...
- 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...
- A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow-up
What rules you out
- 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...
- 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.
- 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...
- 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)
- 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...
- \>460 milliseconds (msec)
- \>480 msec for participants with bundle branch block
The study team makes the final eligibility decision.
Where it is enrolling
- Mobile, Alabama, United States
- Colorado Springs, Colorado, United States
- Watertown, South Dakota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Mobile, Alabama, United States; Colorado Springs, Colorado, United States; Watertown, South Dakota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.