Depemokimab for Asthma

(NIMBLE Trial)

No longer recruiting at 457 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new treatment, Depemokimab, matches the effectiveness of current medications for people with severe asthma linked to high levels of eosinophils, a type of white blood cell. Participants will either continue their usual asthma medication (mepolizumab or benralizumab) or switch to Depemokimab. The goal is to determine if the new treatment reduces asthma attacks. This trial may suit individuals who have had asthma for over two years, are benefiting from their current asthma medication, and are on regular asthma treatments. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that depemokimab was safe in earlier studies. Patients with type 2 asthma tolerated it well, and no major safety issues were reported. This treatment is administered twice a year and has proven safe for these patients.

Mepolizumab and benralizumab are already FDA-approved for treating severe eosinophilic asthma, indicating they have passed strict safety tests for this condition. Participants using these treatments did not report major safety problems in past studies.

Overall, while individual experiences can vary, current evidence suggests these treatments are generally safe for people with severe asthma with an eosinophilic phenotype. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for asthma, which include drugs like benralizumab and mepolizumab that target the interleukin-5 pathway, Depemokimab offers a unique approach. Depemokimab is designed to target and neutralize interleukin-5 (IL-5) with a novel mechanism, potentially providing longer-lasting relief by requiring less frequent dosing. Researchers are excited about Depemokimab because it might offer more convenience and sustained control of asthma symptoms, which could improve adherence and quality of life for patients.

What evidence suggests that this trial's treatments could be effective for severe asthma?

Research has shown that Depemokimab, a new treatment for severe asthma with a specific type of inflammation, looks promising. In earlier studies, this treatment reduced severe asthma attacks by 54% compared to a placebo. Specifically, patients experienced a decrease in their yearly rate of asthma flare-ups from 1.08 to 0.56. In this trial, some participants will receive Depemokimab, which targets a protein involved in asthma symptoms and is administered only twice a year. This evidence suggests that Depemokimab could effectively manage severe asthma. ^{1 2 4 6 7}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

1. 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 ... AER = 0.56 annual exacerbation rate in the depemokimab group vs. 1.08 in the placebo group. An additional study (NIMBLE) is underway to assess ...

2. 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.

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

Twice-Yearly Depemokimab in Severe Asthma with an ... Depemokimab is an ultra-long-acting biologic therapy with enhanced binding affinity for interleukin-5 that may enable effective 6-month ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04718389

NCT04718389 | A Study of GSK3511294 (Depemokimab ... This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior.

5. 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.

6. jacionline.org jacionline.org/article/S0091-6749(24)02265-6/fulltext

Twice-Yearly Depemokimab Demonstrates an Acceptable ... Depemokimab, the first ultra-long-acting anti-IL-5 biologic administered twice-yearly, demonstrated efficacy and safety in patients with type 2 asthma.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04718389

NCT04718389 | A Study of GSK3511294 (Depemokimab ... This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior.