What side effects are associated with this type of intervention?

Monoclonal antibody treatments for asthma, such as those targeting IL-5 (e.g., mepolizumab, benralizumab), are generally well-tolerated but can have side effects. Common side effects include injection site reactions, headache, back pain, and fatigue. More serious but less common side effects may include hypersensitivity reactions and increased risk of infections. Other common asthma treatments, such as inhaled corticosteroids and bronchodilators, can cause side effects like oral thrush, hoarseness, and increased heart rate.

What prior FDA approvals exist?

Several monoclonal antibodies targeting IL-5 or related pathways have been approved by the FDA for the treatment of severe eosinophilic asthma. Mepolizumab, an anti-IL-5 antibody, reduces eosinophil levels and has shown efficacy in improving asthma control and reducing exacerbations. Benralizumab, another anti-IL-5 receptor alpha antibody, depletes eosinophils and has demonstrated similar benefits. Reslizumab, also targeting IL-5, is used for patients with elevated blood eosinophils. These biologics are used as add-on therapies for patients with severe asthma not adequately controlled by standard treatments.

What other types of research exist?

Promising novel alternatives to GSK3511294 (Depemokimab) for asthma treatment in 2024 include: 1. Dupilumab (targets IL-4 and IL-13) - already approved for moderate-to-severe asthma with an eosinophilic phenotype. 2. Tezepelumab (targets thymic stromal lymphopoietin, TSLP) - shown to reduce exacerbations in severe asthma. 3. Benralizumab (targets IL-5 receptor) - approved for severe eosinophilic asthma. These therapies offer different mechanisms of action and have shown efficacy in reducing asthma exacerbations and improving lung function.

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Depemokimab for Asthma (SWIFT-2 Trial)

Phase 3

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have a documented physician diagnosis of asthma for >=2 years that meets the National Heart, Lung, and Blood Institute guidelines (NHLBI) or Global Initiative for Asthma (GINA) guidelines

Documented physician diagnosis of asthma for >=2 years that meets the National Heart, Lung, and Blood Institute guidelines (NHLBI) or Global Initiative for Asthma (GINA) guidelines

Must not have

Changes in the dose or regimen of Baseline ICS and/or additional controller medication during the run-in period

Presence of a known pre-existing, clinically important lung condition other than asthma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1) and week 52

Awards & highlights

Pivotal Trial

Summary

This trial is testing Depemokimab to help people with severe asthma that doesn't respond well to other treatments. It targets and reduces specific white blood cells to decrease inflammation and improve symptoms.

Who is the study for?

This trial is for adults and adolescents (12 years or older) with severe uncontrolled asthma characterized by an eosinophilic phenotype. Participants must have been diagnosed with asthma for at least 2 years, following specific guidelines, and should be on a stable dose of high-dose inhaled corticosteroids. They need to have had two or more exacerbations requiring systemic steroids in the past year.

What is being tested?

The study tests Depemokimab as additional therapy for those with severe eosinophilic asthma. It compares the effects of Depemokimab against a placebo to see if it improves symptoms and control of asthma.

What are the potential side effects?

Potential side effects may include reactions at the injection site, increased risk of infections due to immune system suppression, headaches, fatigue, and possible allergic reactions among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with asthma for 2 years or more, following NHLBI or GINA guidelines.

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I have been diagnosed with asthma for 2 years or more, according to NHLBI or GINA guidelines.

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I've needed steroids for asthma attacks at least twice in the last year despite using inhalers.

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I use a medium to high dose inhaler for my asthma daily.

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I am 12-17 years old with specific lung function test results below normal.

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I've had 2 or more severe asthma attacks in the last year despite using my regular medication.

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I have breathing issues with less than 80% normal lung function.

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I am 12 years old or older.

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My lung function tests show I have airflow obstruction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My asthma medication dose or type hasn't changed recently.

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I have a significant lung condition that is not asthma.

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I do not have any uncontrolled serious health issues.

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I do not have cirrhosis or current unstable liver/biliary disease.

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I have been diagnosed with vasculitis.

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My cancer has been in remission for less than a year, except for skin cancer.

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I have not had a severe asthma attack in the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) and week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1) and week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks

Secondary study objectives

Annualized Rate of Exacerbations Requiring Hospitalization and/or Emergency Department (ED) Visit up to 52 Weeks

Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52

Change From Baseline in Asthma Daily Symptom Diary (ADSD) Weekly Mean Score at Week 52

+3 more

Side effects data

From 2024 Phase 3 trial • 397 Patients • NCT04718103

14%

COVID-19

13%

Nasopharyngitis

Headache

Upper respiratory tract infection

Rhinitis allergic

Arthralgia

Bronchitis

Sinusitis

Pharyngitis

Dizziness

Rhinitis

Diarrhoea

Asthma

Back pain

Hypertension

Respiratory tract infection

Urinary tract infection

Lower respiratory tract infection

Influenza

Oropharyngeal pain

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

GSK3511294

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GSK3511294Experimental Treatment1 Intervention

Participants received a 100 milligram (mg) dose of GSK3511294 subcutaneous (SC) injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.

Group II: PlaceboPlacebo Group1 Intervention

Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GSK3511294

2021

Completed Phase 3

~470

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

GSK3511294 (Depemokimab) is a monoclonal antibody that targets interleukin-5 (IL-5), a key cytokine involved in the growth, activation, and survival of eosinophils. By binding to IL-5, Depemokimab reduces the levels of eosinophils in the blood and tissues, which are often elevated in patients with eosinophilic asthma. This reduction in eosinophils helps to decrease inflammation and improve asthma control. Similar treatments, such as mepolizumab and reslizumab, also target IL-5 or its receptor to achieve these effects. For asthma patients, particularly those with severe eosinophilic asthma, these treatments can significantly reduce exacerbations, improve lung function, and enhance quality of life by addressing the underlying inflammatory processes.