Mepolizumab for Severe Asthma
(REIMAGINE Trial)
Recruiting in Palo Alto (17 mi)
+58 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: GlaxoSmithKline
Must be taking: Nucala
Must not be taking: Omalizumab, Reslizumab, Dupilumab, others
Disqualifiers: Maintenance OCS, Interventional study, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a prospective, real-world, single arm, global, multi-centre study to evaluate the effect of timely treatment with mepolizumab (NUCALA) to achieve clinical remission in adult participants with severe asthma with an eosinophilic phenotype (SA-EP).
Will I have to stop taking my current medications?
The trial requires that participants not be on certain medications like maintenance oral corticosteroids or specific biologics such as omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within 6 months before joining. If you're on these, you may need to stop them before participating.
What data supports the effectiveness of the drug Mepolizumab for severe asthma?
Research shows that Mepolizumab significantly reduces asthma attacks in patients with severe eosinophilic asthma (a type of asthma with high levels of a specific white blood cell). It also improves symptoms and lung function over time.
12345Is mepolizumab safe for humans?
Mepolizumab has been evaluated for safety in patients with severe eosinophilic asthma, and studies have shown it to be generally safe for use in humans.
678910How is the drug Mepolizumab different from other asthma treatments?
Mepolizumab is unique because it is an anti-IL-5 antibody specifically designed to treat severe eosinophilic asthma by targeting and reducing eosinophils, a type of white blood cell that contributes to asthma symptoms. This makes it different from other treatments like omalizumab, which targets different pathways in asthma management.
26111213Eligibility Criteria
This trial is for adults with severe asthma who have been prescribed NUCALA (mepolizumab) and haven't used it in the last 6 months. Participants should be able to breathe out at least 60% of what's expected in one second and have had no more than 4 severe asthma attacks per year.Inclusion Criteria
I haven't used NUCALA in the last 6 months.
Participants with ≥60% predicted forced expiratory volume in 1 second (FEV1) and ≤4 exacerbations per year, as confirmed by the physician
Written informed consent
+2 more
Exclusion Criteria
Investigator concerns about participant's willingness to adhere to biologic treatment for any reason (e.g., cost, behavior, difficulty with access to healthcare)
Participants participating in an interventional study with a treatment intervention
I am currently taking maintenance oral or intramuscular corticosteroids.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive mepolizumab as part of routine care for severe asthma
12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The REIMAGINE study is testing how well mepolizumab works in the real world for adults with severe eosinophilic asthma. It's a global study where everyone gets mepolizumab, and doctors check if patients reach 'clinical remission,' meaning their symptoms are under control or gone.
1Treatment groups
Experimental Treatment
Group I: Group 1Experimental Treatment2 Interventions
Participants with a clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
GSK Investigational SiteLittle Rock, AR
GSK Investigational SiteNewport Beach, CA
GSK Investigational SiteAurora, CO
GSK Investigational SiteLa Jolla, CA
More Trial Locations
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Who Is Running the Clinical Trial?
GlaxoSmithKlineLead Sponsor
References
Benralizumab and mepolizumab treatment outcomes in two severe asthma clinics. [2023]This study compared the clinical outcomes of severe asthmatics treated with mepolizumab and benralizumab in a tertiary care severe asthma service setting.
The clinical benefit of mepolizumab replacing omalizumab in uncontrolled severe eosinophilic asthma. [2021]Mepolizumab and omalizumab are treatments for distinct but overlapping severe asthma phenotypes.
Evaluation of Potential Continuation Rules for Mepolizumab Treatment of Severe Eosinophilic Asthma. [2019]Mepolizumab significantly reduces exacerbations in patients with severe eosinophilic asthma. The early identification of patients likely to receive long-term benefit from treatment could ensure effective resource allocation.
[Effectiveness of mepolizumab in patients with severe eosinophilic asthma: In a real life study]. [2023]We analyzed the effects of mepolizumab treatment on symptoms, asthma attacks, pulmonary function test parameters peripheral blood eosinophil level, and percentage in patients with severe eosinophilic asthma receiving mepolizumab treatment as the baseline, sixth and twelfthmonth data.
Real-Life Performance of Mepolizumab in T2-High Severe Refractory Asthma with the Overlapping Eosinophilic-Allergic Phenotype. [2023]Severe asthma (SA) is categorized into multiple overlapping phenotypes and clinical characteristics driven by complex mechanistic inflammatory pathways. Mepolizumab is a human monoclonal antibody effectively targeting interleukin-5 in severe eosinophilic asthma. However, the eligibility of biologics in coincident SA phenotypes is still unclear. We assessed the efficacy and safety of mepolizumab in real-life patients with the overlapping T2-high SA endotype. This was a phase IV, single-centre observational cohort study including patients with severe refractory T2-high asthma in treatment with mepolizumab. After 12 months of treatment with mepolizumab, significant improvements (p
The Role of ACT Score in Mepolizumab Discontinuation. [2023]Mepolizumab is a therapy for severe asthma. There is little knowledge of the characteristics of people in the US that discontinue mepolizumab in clinical care.
Real-life effectiveness of mepolizumab in patients with severe refractory eosinophilic asthma and multiple comorbidities. [2022]Data on mepolizumab in patients with severe eosinophilic asthma (EA) and comorbidities are needed to assess whether randomized controlled trial results are applicable in the real world.
Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies. [2021]The efficacy and safety of mepolizumab in patients with severe eosinophilic asthma has been evaluated in a global clinical trial programme. This post hoc analysis assesses the efficacy and safety of mepolizumab in Korean patients.
Mepolizumab improves small airway function in severe eosinophilic asthma. [2020]Treatment with mepolizumab in severe eosinophilic asthma (SEA) significantly reduces exacerbations with modest improvements in symptom control and spirometry. The time course of any changes in small airway function is unknown.
Effectiveness and safety of mepolizumab in severe refractory eosinophilic asthma: results in clinical practice. [2022]Asthma is an inflammatory disease of the airways with symptoms that vary over time and intensity, sometimes leading to disability or even death. Eosinophilic asthma accounts for 25% of cases of severe asthma. It is mediated by eosinophils regulated by interleukin-5 (IL-5), the target of mepolizumab, which has been recently licensed as an add-on treatment of severe refractory eosinophilic asthma. The aim of this study was to evaluate the effectiveness and safety of mepolizumab in clinical practice.
Proportion of Severe Asthma Patients Eligible for Mepolizumab Therapy by Age and Age of Onset of Asthma. [2020]Mepolizumab is an anti-IL-5 antibody approved for the treatment of severe eosinophilic asthma. However, the prevalence of patients with severe asthma eligible for mepolizumab remains unknown, especially among children.
[Innovations in the treatment of severe asthma]. [2019]In severe asthma, there is a real need for new effective therapies offering a good safety and tolerance profile. Mepolizumab is a humanized anti-interleukin-5 monoclonal antibody, available in Switzerland since 2016 for treatment of severe adult eosinophilic asthma. Other monoclonal antibodies, such as dupilumab, are being developed in the field of asthma.
Evaluation of the Clinical Features and Laboratory Data of Patients with Severe Eosinophilic Asthma Classified as Super-Responders, Partial Responders, or Nonresponders to Mepolizumab Treatment: A Real-Life Study. [2023]Mepolizumab is a treatment option in patients with severe eosinophilic asthma, which inhibits interleukin-5. The aim of this study was to evaluate the clinical features and laboratory data of patients with severe eosinophilic asthma who were classified as super-responders, partial responders, or nonresponders to mepolizumab treatment.