456 Participants NeededMy employer runs this trial

Depemokimab for Asthma

(MODIFY Trial)

Recruiting at 14 trial locations
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: GlaxoSmithKline
Must be taking: Inhaled corticosteroids, LABA
Stay on Your Current MedsYou can continue your current medications while participating
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests depemokimab, a new treatment for people with Type 2 asthma who risk frequent asthma attacks. The goal is to determine if adding this treatment to standard care can better prevent these attacks compared to the usual treatment alone. Participants will receive either depemokimab or a placebo (a harmless substitute) alongside their regular asthma care. This trial suits individuals who have had asthma for at least two years and have experienced at least two asthma attacks requiring extra medication in the past three years. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially groundbreaking treatment.

Is there any evidence suggesting that depemokimab is likely to be safe for humans?

Research has shown that depemokimab is generally safe for people with type 2 asthma. Studies found that patients taking depemokimab experienced fewer issues such as pneumonia, the common cold, runny nose, and back pain compared to those not taking it. In some trials, about 72% to 73% of patients reported experiencing side effects, but these were similar to those taking a placebo (a harmless pill with no active drug). This suggests that the side effects are neither unusual nor severe. Overall, depemokimab appears safe for most patients.12345

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

Depemokimab is unique because it targets and blocks the activity of a specific protein called IL-5, which plays a key role in the inflammation process associated with asthma. Unlike standard treatments like inhaled corticosteroids or leukotriene modifiers, which generally aim to reduce inflammation or relax the airways, Depemokimab specifically interferes with the signaling pathway that leads to the production of eosinophils, a type of white blood cell that often causes airway inflammation in asthma patients. This targeted approach could offer more precise control over asthma symptoms, potentially leading to better outcomes for patients who don't respond well to existing therapies. Researchers are excited about the potential for Depemokimab to provide a new, more effective option for managing asthma, especially for those with severe forms of the condition.

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

Research has shown that depemokimab, which participants in this trial may receive, benefits people with type 2 asthma, particularly those at risk of severe flare-ups. Studies indicate that this treatment can reduce severe asthma attacks by up to 54% compared to a placebo. One study found that individuals using depemokimab had a 46% lower chance of experiencing their first asthma attack over a year. It also proves effective regardless of whether a person's asthma is well-controlled. Overall, these findings suggest depemokimab holds promise for better asthma management.14567

Who Is on the Research Team?

GC

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This trial is for adults and teens aged 12 or older who have had asthma for at least 2 years, are already on regular inhaled steroid and LABA treatment, and have had at least two asthma flare-ups in the past three years (with one in the last year) needing extra steroids. Women of childbearing age must use effective birth control.

Inclusion Criteria

I have had a doctor's diagnosis of asthma for at least 2 years.
I have type 2 high asthma with high eosinophil counts or nasal polyps.
I am at least 12 years old, or 18 if required by local laws.
See 4 more

Exclusion Criteria

Known evidence of non-adherence to controller medications or inability to follow physician recommendations
History or suspected alcohol or substance abuse within 2 years prior to first dose
Current smokers or former smokers with >=20 pack years and vapers
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive depemokimab or placebo along with standard of care for Type 2 asthma

156 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Depemokimab

Trial Overview

The study compares a new drug called depemokimab to a placebo, both given alongside standard asthma treatments. Participants are randomly assigned to receive either depemokimab or placebo to see if the new drug helps prevent asthma attacks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: DepemokimabExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

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 profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

Depemokimab demonstrates efficacy in patients with type 2 ...

The results demonstrated that twice-yearly depemokimab improved asthma outcomes vs. placebo in patients with both type 2 asthma characterized by blood ...

Efficacy and safety of Depemokimab in asthma with ... - PMC

Two randomized controlled trials (n = 762) were included. Depemokimab significantly reduced the annualized rate of exacerbations (MD -0.59, 95% CI [-0.76 to - ...

Depemokimab late-breaking data presented at ERS show ...

Depemokimab late-breaking data presented at ERS show a 54% reduction in severe asthma exacerbations · About the depemokimab development programme.

Early and Sustained Efficacy of Depemokimab in Type 2 ...

Results. Depemokimab reduced the probability of first exacerbation over 52 weeks versus placebo by 46% (hazard ratio = 0.54; 95% CI, 0.43-0.69) ...

NCT04718103 | A Study of GSK3511294 (Depemokimab) ...

This study will assess the efficacy and safety of GSK3511294 (Depemokimab) as an adjunctive therapy in participants with severe uncontrolled asthma

Depemokimab reduces asthma exacerbations similarly to ...

In the Phase III SWIFT 1 and SWIFT 2 trials, depemokimab significantly reduced exacerbations vs placebo, with sustained suppression of ...

Study Details | NCT04719832 | Placebo-controlled Efficacy ...

Safety and Tolerability of Twice-Yearly Depemokimab in Patients with Asthma and Chronic sal Polyps: Pooled Results from SWIFT-1/-2 and ANCHOR-1/-2. safety data ...