Depemokimab for Asthma

(SWIFT-2 Trial)

No longer recruiting at 192 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must be taking: ICS, LABA

Must not be taking: Anti-IL-5, mAb

Disqualifiers: Lung conditions, Cancer, Vasculitis, others

Stay on Your Current Meds You can continue your current medications while participating

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: 2

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Depemokimab (GSK3511294) to determine its effectiveness for people with severe, hard-to-control asthma. It targets those with asthma linked to high levels of eosinophils, a type of white blood cell that can worsen asthma. Participants must have had asthma for at least two years, with frequent flare-ups requiring extra medication despite current treatment. The trial compares the effects of Depemokimab to a placebo to evaluate its efficacy and safety. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that participants must be on regular treatment with medium to high-dose inhaled corticosteroids and at least one additional controller medication for asthma. It's best to discuss your specific medications with the trial team.

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

Research has shown that Depemokimab is generally well-tolerated in people with severe asthma linked to high levels of a certain type of white blood cell. Studies have found that it can significantly reduce asthma flare-ups, with patients experiencing fewer severe attacks compared to those taking a placebo.

Depemokimab is recognized for its safety. Reports indicate it is effective with few side effects. Administered only twice a year, it requires less frequent dosing than many other treatments, possibly reducing the risk of side effects from the treatment process. Overall, evidence suggests this treatment is safe, offering a promising option for those with severe asthma. ^{1 2 3 4 5}

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

Depemokimab is unique because it targets a specific protein called IL-5, which plays a key role in causing inflammation in asthma. Unlike typical asthma treatments such as inhaled corticosteroids and bronchodilators, which focus on managing symptoms or opening airways, Depemokimab works by directly reducing the inflammation process itself. This innovative approach may lead to longer-lasting relief with just two injections a year, offering a more convenient option for patients compared to daily medications. Researchers are excited about its potential to significantly improve the quality of life for those with asthma by addressing the root cause of inflammation.

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

Research has shown that Depemokimab, which participants in this trial may receive, can greatly reduce severe asthma symptoms. In studies, individuals who took Depemokimab experienced 54% fewer asthma flare-ups compared to those who took a placebo, a harmless pill with no active medicine. On average, those using Depemokimab had about 0.56 flare-ups per year, while those on the placebo had about 1.08. This indicates that Depemokimab users experienced fewer asthma attacks. The medication targets a protein called interleukin-5, which plays a role in asthma symptoms, potentially allowing for effective treatment with just two doses a year. These findings suggest that Depemokimab could be a promising option for managing severe eosinophilic 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?

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

I have used asthma medication recently.

Your heart's electrical activity, called the QT interval, is longer than normal.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GSK3511294 or placebo subcutaneous injection every 26 weeks, while maintaining their existing baseline maintenance asthma standard of care treatment

52 weeks

2 visits (in-person) at week 0 and week 26

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 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.

How Is the Trial Designed?

Group I: GSK3511294 Experimental Treatment 1 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: Placebo Placebo Group 1 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.

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

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.