Depemokimab for Asthma
(MODIFY 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive depemokimab or placebo along with standard of care for Type 2 asthma
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants will be administered depemokimab along with standard of care (SoC).
Participants will be administered placebo along with SoC
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
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
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 ...
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