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Active, not recruitingNCT06041386ClinicalTrials.gov record

REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study

Asthma

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Phase 4
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
177 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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).

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • Participant has a confirmed asthma diagnosis and has been prescribed NUCALA by their physician for the treatment of asthma, as per local label. NUCALA can be initiated up to 7 days prior to study enrollment.
  • No NUCALA use in the 6 months prior to enrollment.
  • Participants with greater than or equal to (≥)60 percentage (%) predicted forced expiratory volume in 1 second (FEV1) and less than or equal to (≤)4 exacerbations per year, as confirmed by the physician.
  • Other local prescription criteria of NUCALA not described above at NUCALA initiation (e.g., local reimbursement criteria).
  • Written informed consent

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 currently on maintenance OCS or intramuscular corticosteroids.
  • Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment
  • Participants participating in an interventional study with a treatment intervention
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not applicable
Masking
No masking
Group 1

Participants with a clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care.

Drug: Mepolizumab · Other: Spirometry

Mepolizumab DRUG

Mepolizumab will be prescribed based on physician decision.

Spirometry OTHER

Lung function via spirometry will be collected.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Percentage (%) of Participants Achieving 4-Component Clinical Remission

Time frame: At month 12

4-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an Asthma Control Test (ACT) (d) No clinically significant deterioration of lung function.

Secondary measures

Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits

Time frame: At month 12

CSE is defined as a deterioration in asthma requiring (1) the initiation of systemic corticosteroids and/or (2) an ER visit and/or hospital admission.

Percentage of Participants Achieving OCS Sparing Remission

Time frame: At month 12

OCS sparing is defined as (a) No clinically significant asthma exacerbations during the period of interest (b) No OCS use for asthma at the time point of interest.

Percentage of Participants Achieving 3-Component Clinical Remission

Time frame: At month 12

3-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an ACT

Mean Change from Baseline in Mini-Asthma Quality of Life Questionnaire (AQLQ) Overall Score

Time frame: Baseline and at month 12

The mini-AQLQ overall score is a reduced version of the AQLQ which includes 15 items. The minimally clinically important difference (MCID) is 0.5. The response options for each item are on an equidistant scale of 7 points, where 1 corresponds to the maximum disability and 7 to the absence of disability

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (65)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

65 locations

GSK Investigational SiteLa Jolla, California, United StatesStatus unknown
GSK Investigational SiteNewport Beach, California, United StatesStatus unknown
GSK Investigational SiteAurora, Colorado, United StatesStatus unknown
GSK Investigational SiteColorado Springs, Colorado, United StatesStatus unknown
GSK Investigational SiteNew Haven, Connecticut, United StatesStatus unknown
GSK Investigational SiteHomestead, Florida, United StatesStatus unknown
GSK Investigational SiteJacksonville, Florida, United StatesStatus unknown
GSK Investigational SiteMiami, Florida, United StatesStatus unknown
GSK Investigational SitePlantation, Florida, United StatesStatus unknown
GSK Investigational SiteAdairsville, Georgia, United StatesStatus unknown
GSK Investigational SiteColumbus, Georgia, United StatesStatus unknown
GSK Investigational SiteLexington, Kentucky, United StatesStatus unknown
GSK Investigational SiteOwensboro, Kentucky, United StatesStatus unknown
GSK Investigational SiteNew Orleans, Louisiana, United StatesStatus unknown
GSK Investigational SiteGlenn Dale, Maryland, United StatesStatus unknown
GSK Investigational SiteTowson, Maryland, United StatesStatus unknown
GSK Investigational SiteAnn Arbor, Michigan, United StatesStatus unknown
GSK Investigational SiteLinwood, Minnesota, United StatesStatus unknown
GSK Investigational SiteRochester, Minnesota, United StatesStatus unknown
GSK Investigational SiteHenderson, Nevada, United StatesStatus unknown
GSK Investigational SiteRochester, New York, United StatesStatus unknown
GSK Investigational SiteSchenectady, New York, United StatesStatus unknown
GSK Investigational SitePhiladelphia, Pennsylvania, United StatesStatus unknown
GSK Investigational SitePhiladelphia, Pennsylvania, United StatesStatus unknown
GSK Investigational SiteUnion, South Carolina, United StatesStatus unknown
GSK Investigational SiteCypress, Texas, United StatesStatus unknown
GSK Investigational SiteKerrville, Texas, United StatesStatus unknown
GSK Investigational SiteMcKinney, Texas, United StatesStatus unknown
GSK Investigational SiteKortrijk, BelgiumStatus unknown
GSK Investigational SiteLiège, BelgiumStatus unknown
GSK Investigational SiteCalgary, Alberta, CanadaStatus unknown
GSK Investigational SiteCalgary, Alberta, CanadaStatus unknown
GSK Investigational SiteWinnipeg, Manitoba, CanadaStatus unknown
GSK Investigational SiteToronto, Ontario, CanadaStatus unknown
GSK Investigational SiteBrest, FranceStatus unknown
GSK Investigational SiteCannes, FranceStatus unknown
GSK Investigational SiteLille, FranceStatus unknown
GSK Investigational SiteLyon, FranceStatus unknown
GSK Investigational SiteStrasbourg, FranceStatus unknown
GSK Investigational SiteToulouse, FranceStatus unknown
GSK Investigational SiteDarmstadt, Hesse, GermanyStatus unknown
GSK Investigational SiteFrankfurt am Main, Hesse, GermanyStatus unknown
GSK Investigational SiteAachen, North Rhine-Westphalia, GermanyStatus unknown
GSK Investigational SiteBonn, GermanyStatus unknown
GSK Investigational SiteHohenstein-Ernsttal, GermanyStatus unknown
GSK Investigational SiteSchleswig, GermanyStatus unknown
GSK Investigational SiteGenova, ItalyStatus unknown
GSK Investigational SiteMonserrato CA, ItalyStatus unknown
GSK Investigational SiteNaples, ItalyStatus unknown
GSK Investigational SitePieve Di Soligo TV, ItalyStatus unknown
GSK Investigational SiteRoma, ItalyStatus unknown
GSK Investigational SiteRoma, ItalyStatus unknown
GSK Investigational SiteRozzano, ItalyStatus unknown
GSK Investigational SiteVerona, ItalyStatus unknown
GSK Investigational SiteGifu, JapanStatus unknown
GSK Investigational SiteKagawa, JapanStatus unknown
GSK Investigational SiteTokyo, JapanStatus unknown
GSK Investigational SiteTokyo, JapanStatus unknown
GSK Investigational SiteTokyo, JapanStatus unknown
GSK Investigational Site?Od?, PolandStatus unknown
GSK Investigational SiteGdansk, PolandStatus unknown
GSK Investigational SiteLodz, PolandStatus unknown
GSK Investigational SiteBarcelona, SpainStatus unknown
GSK Investigational SiteGirona, SpainStatus unknown
GSK Investigational SiteValencia, SpainStatus unknown

Study team and timeline

Lead sponsor
GlaxoSmithKline
Study start
Mar 20, 2024 Actual
Primary completion
Feb 12, 2026 Actual
Study completion
Mar 31, 2027 Estimated
First posted
Sep 18, 2023 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

A Prospective, Real-World, Interventional Study To Evaluate The Effect Of Mepolizumab On Achieving Clinical Remission In Participants With Severe Asthma

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026