Depemokimab for Asthma

(NIMBLE Trial)

Recruiting in Palo Alto (17 mi)

+430 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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.

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

GSK Investigational Site Woodland, CA

GSK Investigational Site White Marsh, MD

GSK Investigational Site Cleveland, OH

GSK Investigational Site Bakersfield, CA

More Trial Locations

Who Is Running the Clinical Trial?

GlaxoSmithKline Lead Sponsor

Iqvia Pty Ltd Industry Sponsor

References