Depemokimab for Asthma

(NIMBLE Trial)

Recruiting at 430 trial locations

Overseen By Rachana Shah

Age: Any Age

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must be taking: Mepolizumab, Benralizumab

Must not be taking: Omalizumab, Dupilumab

Disqualifiers: Lung conditions, Cancer, Smoking, 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: Unknown

Duration: 52 weeks

1719 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called Depemokimab for people with severe asthma who have high levels of certain white blood cells. The goal is to see if switching to Depemokimab works as well as their current treatments. The medication aims to reduce these white blood cells to help control asthma symptoms.

Will I have to stop taking my current medications?

The trial does not require you to stop your current non-biologic asthma medications. You will continue your usual asthma treatment while participating in the study.

What data supports the effectiveness of the drug Depemokimab for asthma?

Research shows that benralizumab and mepolizumab, which are similar to Depemokimab, help reduce asthma attacks and the need for oral steroids in people with severe eosinophilic asthma. These drugs target specific proteins involved in inflammation, which can help control asthma symptoms. ^{1 2 3 4 5}

Is Depemokimab (also known as Benralizumab or Fasenra) safe for humans?

Benralizumab, also known as Fasenra, has been used as a treatment for severe asthma and is generally considered safe, as it has been approved for use in patients with severe eosinophilic asthma. It is a type of medication called a monoclonal antibody, which targets specific proteins in the body to help reduce asthma symptoms. ^{1 2 3 5 6}

How is the drug Depemokimab for asthma different from other treatments?

Depemokimab (GSK3511294) is a novel treatment for asthma that targets the same pathway as existing drugs like Mepolizumab and Benralizumab, which are monoclonal antibodies that reduce inflammation by targeting specific proteins involved in severe eosinophilic asthma. This drug may offer a new option for patients who do not respond adequately to current treatments. ^{1 3 5 6 7}

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

Adults and adolescents (12+ years) with severe asthma who've been on medium to high dose inhalers for the past year, plus another controller medication. They must have shown improvement with Mepolizumab or Benralizumab treatments. Not for current/former heavy smokers, those with other lung conditions, cancer in remission <1 year, or certain blood disorders.

Inclusion Criteria

I've been on a medium to high dose asthma inhaler for the past year.

I am currently taking a medication in addition to inhaled corticosteroids for my condition.

I've been on mepolizumab or benralizumab for 12 months with significant improvement.

Exclusion Criteria

I have been diagnosed with vasculitis.

I have smoked for 10 or more years but quit at least 6 months ago.

I have a condition that increases my eosinophil levels, like EGPA or Eosinophilic Esophagitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either GSK3511294 (Depemokimab) or continue with their prior anti-IL-5/5R treatment for severe asthma

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Benralizumab
• GSK3511294 (Depemokimab)
• Mepolizumab
• Pre-filled Syringes (PFS)

Trial Overview The trial is testing if Depemokimab (GSK3511294) is as effective as Mepolizumab or Benralizumab in reducing asthma attacks when added to standard care. Participants will either continue their current treatment or switch to Depemokimab while maintaining their usual non-biologic asthma medications.

Participant Groups

Group I: Participants receiving GSK3511294 (Depemokimab) plus placebo matching prior anti-IL-5/5R treatment Experimental Treatment 4 Interventions

Participants will receive GSK3511294 (Depemokimab) plus placebo treatment matching the active comparator (participant's anti-Interleukin-5/ 5 receptor \[anti-IL-5/5R\] treatment prior to randomization): either placebo matching mepolizumab or placebo matching benralizumab. All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.

Group II: Participants receiving prior anti-IL-5/5R treatment plus placebo matching GSK3511294 (Depemokimab) Active Control 5 Interventions

Participants will receive active comparator (participant's anti-IL-5/5R treatment prior to randomization): either mepolizumab or benralizumab, plus placebo matching GSK3511294 (Depemokimab). All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.

Benralizumab is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Fasenra for:

• Severe eosinophilic asthma

Approved in United States as Fasenra for:

• Severe asthma with an eosinophilic phenotype

Approved in Canada as Fasenra for:

• Severe eosinophilic asthma

Approved in Japan as Fasenra for:

• Severe eosinophilic asthma

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

Findings from Research

In a study of 441 patients with severe asthma, 19% were found to be eligible for benralizumab treatment, indicating a significant subset of patients who may benefit from this therapy.

Patients eligible for benralizumab had poorer lung function and asthma control, experiencing more frequent exacerbations and hospitalizations, highlighting the need for effective treatment options in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort. Aubier, M., Thabut, G., Fabry-Vendrand, C.[2022]

In a study of 204 severe asthmatics treated with either mepolizumab or benralizumab, both medications significantly improved asthma control and reduced exacerbations after 6 and 12 months.

However, benralizumab was found to be more effective than mepolizumab, showing greater improvements in lung function (FEV1) and a more substantial reduction in blood eosinophil counts, indicating its potential as a superior treatment option for severe eosinophilic asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benralizumab and mepolizumab treatment outcomes in two severe asthma clinics. Langton, D., Politis, J., Collyer, T., et al.[2023]

Mepolizumab (Nucala) is an effective treatment for patients with severe eosinophilic asthma, targeting and reducing eosinophil levels to help control asthma symptoms.

Clinical studies have shown that mepolizumab significantly decreases asthma exacerbations and improves lung function in patients with high eosinophil counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mepolizumab (Nucala) For Severe Eosinophilic Asthma. Choy, MS., Dixit, D., Bridgeman, MB.[2020]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Benralizumab and mepolizumab treatment outcomes in two severe asthma clinics. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Benralizumab in Patients with Severe Eosinophilic Asthma: A Multicentre Real-Life Experience. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Comparative Efficacy and Safety of Tezepelumab and Other Biologics in Patients with Inadequately Controlled Asthma According to Thresholds of Type 2 Inflammatory Biomarkers: A Systematic Review and Network Meta-Analysis. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Personalized Approach of Severe Eosinophilic Asthma Patients Treated with Mepolizumab and Benralizumab. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Differential redox proteomic profiles of serum from severe asthma patients after one month of benralizumab and mepolizumab treatment. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Mepolizumab (Nucala) For Severe Eosinophilic Asthma. [2020]