Depemokimab for Severe Asthma

(AGILE Trial)

Not currently recruiting at 166 trial locations

Overseen By Anne W White

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Disqualifiers: Malignancy, Uncontrolled cardiovascular, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the long-term safety and effectiveness of a new treatment called Depemokimab for people with severe asthma. Researchers are testing Depemokimab to assess its efficacy and safety, particularly for those with an eosinophilic phenotype, a type of asthma involving high levels of certain white blood cells. The study is open to participants who have completed previous related studies with Depemokimab. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment for severe asthma.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that GSK3511294 (Depemokimab) is likely to be safe for humans?

Research has shown that GSK3511294, also known as Depemokimab, is generally safe for individuals with severe asthma. In studies, Depemokimab reduced severe asthma attacks by 54% over a year, meaning patients experienced fewer attacks compared to those not using it.

While the studies primarily assess the treatment's effectiveness, they also emphasize safety. Patients using Depemokimab did not report any unexpected side effects, indicating it is safe for most individuals.

As this trial is in a late stage, extensive safety information is available. Treatments reaching this stage have typically demonstrated safety in earlier studies with participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for severe asthma?

Depemokimab is unique because it targets interleukin-5 (IL-5), a protein that plays a key role in the inflammation process associated with severe asthma. Unlike standard treatments, such as inhaled corticosteroids and bronchodilators, which focus on managing symptoms, Depemokimab aims to address the root cause by reducing the activity of IL-5. This targeted approach has the potential to significantly decrease asthma attacks and improve overall lung function. Researchers are excited about Depemokimab because it offers a novel mechanism that could provide better control for patients with severe asthma who do not respond well to existing therapies.

What evidence suggests that Depemokimab might be an effective treatment for severe asthma?

Research has shown that Depemokimab, which participants in this trial will receive, helps reduce asthma attacks in people with severe asthma linked to high levels of a certain type of white blood cell. One study found it reduced the number of severe asthma flare-ups by 54% annually, meaning patients experienced fewer episodes of worsened asthma. Administered twice a year, the treatment has shown promising results in helping patients manage their symptoms more effectively. These findings suggest that Depemokimab could be a beneficial option for those struggling with severe asthma. ^{1 2 3 6 7}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This trial is for people with severe asthma who finished previous studies (206713 or 213744) without major health changes. They must be able to consent and follow study rules. In France, they need social security coverage. Those with recent other treatments, helminth infections, cancer during past studies, uncontrolled diseases besides asthma can't join.

Inclusion Criteria

Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

You have already finished taking part in a previous study where the treatment was kept secret from the participants and researchers.

In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category

Exclusion Criteria

Clinically significant change in health status during Study 206713 or Study 213744 which in the opinion of the investigator would make the participant unsuitable for participation in this study

You have taken part in a research study or used an experimental medication within the last 30 days or within 5 times the drug's half-life, whichever is longer, before starting this study.

I have a new or existing cancer, but skin cancer treated by surgery doesn't count.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension

Participants continue to receive GSK3511294 (Depemokimab) to evaluate long-term safety, efficacy, and immunogenic profile

52 weeks

Baseline (Day 1), Week 26, Week 52

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GSK3511294 (Depemokimab)

Trial Overview The trial tests the long-term safety and effectiveness of Depemokimab in severe eosinophilic asthma patients over 12 months. It's an extension for those who completed prior related trials and aims to understand how well the drug works over time and its effects on the immune system.

How Is the Trial Designed?

Group I: Participants diagnosed with asthma receiving GSK3511294 (Depemokimab) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Iqvia Pty Ltd

Industry Sponsor

Trials

120

Recruited

177,000+

Ari Bousbib

Iqvia Pty Ltd

Chief Executive Officer since 2016

MBA from Columbia University, Master of Science in Mathematics and Mechanical Engineering from Ecole Superieure des Travaux Publics, Paris

Jeffrey Spaeder

Iqvia Pty Ltd

Chief Medical Officer

MD

Published Research Related to This Trial

In a phase 3 study involving 1902 patients, dupilumab significantly reduced severe asthma exacerbations by 63% in patients with chronic rhinosinusitis (CRS) and by 42% in those without CRS, demonstrating its efficacy in managing uncontrolled, moderate-to-severe asthma.

Dupilumab also improved lung function and quality of life for patients in both groups, with rapid and sustained clinical responses observed over 52 weeks, indicating it is a well-tolerated treatment option for asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab Efficacy in Uncontrolled, Moderate-to-Severe Asthma with Self-Reported Chronic Rhinosinusitis. Maspero, JF., Katelaris, CH., Busse, WW., et al.[2021]

Tezepelumab, a monoclonal antibody targeting thymic stromal lymphopoietin, significantly reduced asthma exacerbations by up to 71% in adults with severe, uncontrolled asthma, as shown in the previous PATHWAY phase 2b study.

The ongoing NAVIGATOR phase 3 study, involving 1061 participants, aims to evaluate tezepelumab's efficacy in reducing exacerbations and improving lung function and quality of life across various asthma phenotypes, including those with low eosinophil counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Menzies-Gow, A., Colice, G., Griffiths, JM., et al.[2021]

Dupilumab significantly improves lung function and asthma control in patients with moderate to severe asthma, as evidenced by better forced expiratory volume and asthma control questionnaire scores over 12 and 24 weeks in 13 trials.

The treatment is generally safe, showing no significant increase in adverse events compared to placebo, although it was associated with higher blood eosinophil levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab efficacy and safety in patients with moderate to severe asthma: A systematic review and meta-analysis. Zaazouee, MS., Alwarraqi, AG., Mohammed, YA., et al.[2022]

In a real-life study of 12 patients with severe type-2 asthma, dupilumab treatment for 3 months led to significant improvements in asthma control (ACT score) and lung function (FEV1), indicating its efficacy in managing symptoms.

The treatment also resulted in a notable reduction in FeNO levels, a biomarker for type-2 inflammation, although blood eosinophil counts did not show significant change, suggesting that dupilumab effectively targets the IL4/IL13 pathway in asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early effectiveness of type-2 severe asthma treatment with dupilumab in a real-life setting; a FeNO-driven choice that leads to winning management. Carpagnano, GE., Scioscia, G., Buonamico, E., et al.[2022]

Tezepelumab has shown significant efficacy in treating severe, uncontrolled asthma, as demonstrated in a pooled analysis of the PATHWAY and NAVIGATOR clinical trials, which included a diverse group of participants.

The results indicate that tezepelumab effectively reduces asthma exacerbations and improves lung function, making it a promising treatment option for patients with difficult-to-control asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In severe, uncontrolled asthma, tezepelumab reduced exacerbations over 1 y regardless of type 2 inflammation level. Estrada, RA., Maselli, DJ.[2023]

In the phase 3 NAVIGATOR study involving 97 patients in Japan, tezepelumab significantly reduced asthma exacerbations by 51% compared to placebo, demonstrating its efficacy in managing severe, uncontrolled asthma.

Tezepelumab was well tolerated, with similar rates of adverse events between the treatment and placebo groups, indicating a favorable safety profile for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tezepelumab in patients recruited in Japan who participated in the phase 3 NAVIGATOR study. Ishizuka, T., Menzies-Gow, A., Okada, H., et al.[2023]

In the phase 3 NAVIGATOR study involving patients aged 12-80 with severe asthma, tezepelumab significantly improved various lung function parameters, including pre-bronchodilator FEV1 and forced vital capacity (FVC), compared to placebo over 52 weeks.

Improvements in lung function were observed as early as 1-2 weeks and were particularly pronounced in patients with a shorter disease duration and specific baseline lung function characteristics, indicating tezepelumab's efficacy in managing severe asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Tezepelumab on Lung Function in Patients With Severe, Uncontrolled Asthma in the Phase 3 NAVIGATOR Study. Menzies-Gow, A., Ambrose, CS., Colice, G., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39248309/

Twice-Yearly Depemokimab in Severe Asthma with an ... Depemokimab reduced the annualized rate of exacerbations among patients with severe asthma with an eosinophilic phenotype.

2. gsk.com gsk.com/en-gb/media/press-releases/depemokimab-late-breaking-data-presented-at-ers-show-a-54-reduction-in-severe-asthma-exacerbations/

Depemokimab late-breaking data presented at ERS show ... Depemokimab late-breaking data presented at ERS show a 54% reduction in severe asthma ... Six Monthly Depemokimab in Severe Asthma With an ...

3. nejm.org nejm.org/doi/10.1056/NEJMoa2406673

Twice-Yearly Depemokimab in Severe Asthma with an ... In these phase 3A, randomized, placebo-controlled replicate trials, we evaluated the efficacy and safety of depemokimab in patients with severe ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04719832

Study Details | NCT04719832 | Placebo-controlled Efficacy ... This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that aims to assess the efficacy and safety of GSK3511294 ...

5. pharmacytimes.com pharmacytimes.com/view/depemokimab-every-6-months-reduces-rate-of-severe-asthma-exacerbations

Depemokimab Every 6 Months Reduces Rate of Severe ... A recent study found that depemokimab (GSK3511294; GSK) was successful in reducing the annualized rate of exacerbations in patients with severe asthma with an ...

6. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2406673

Twice-Yearly Depemokimab in Severe Asthma with an ... Depemokimab reduced the annualized rate of exacerbations among patients with severe asthma with an eosinophilic phenotype.

7. healio.com healio.com/news/allergy-asthma/20240913/depemokimab-reduces-severe-asthma-exacerbations-by-half-with-twiceyearly-treatment

Depemokimab reduces severe asthma exacerbations by ... Patients with severe eosinophilic asthma who used depemokimab administered every 6 months experienced a 54% reduction in exacerbations over 52 weeks.