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

July 30, 2025 updated by: GlaxoSmithKline

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
336

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Kortrijk, Belgium, 8500
        • GSK Investigational Site
      • LiEge, Belgium, 4000
        • GSK Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B0M3
        • GSK Investigational Site
      • Calgary, Alberta, Canada
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3L 1Z5
        • GSK Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 1E2
        • GSK Investigational Site
  • France
      • Brest, France, 29200
        • GSK Investigational Site
      • Cannes, France, 06614
        • GSK Investigational Site
      • Lille, France, 59000
        • GSK Investigational Site
      • Lyon, France, 69004
        • GSK Investigational Site
      • Strasbourg, France, 67091
        • GSK Investigational Site
      • Toulouse cedex 9, France, 31059
        • GSK Investigational Site
  • Germany
      • Aachen, Germany, 52074
        • GSK Investigational Site
      • Bonn, Germany, 53119
        • GSK Investigational Site
      • Darmstadt, Germany, 64283
        • GSK Investigational Site
      • Frankfurt, Germany, 60389
        • GSK Investigational Site
      • Hohenstein-Ernsttal, Germany, 9337
        • GSK Investigational Site
      • Schleswig, Germany, 53123
        • GSK Investigational Site
  • Italy
      • Genova, Italy, 16132
        • GSK Investigational Site
      • Monserrato CA, Italy, 09042
        • GSK Investigational Site
      • Napoli, Italy, 80131
        • GSK Investigational Site
      • Pieve Di Soligo TV, Italy, 131044
        • GSK Investigational Site
      • Roma, Italy, 00128
        • GSK Investigational Site
      • Roma, Italy, 161
        • GSK Investigational Site
      • Rozzano, Italy, 20089
        • GSK Investigational Site
      • Verona, Italy, 37126
        • GSK Investigational Site
  • Japan
      • Gifu, Japan, 509-6134
        • GSK Investigational Site
      • Kagawa, Japan, 760-0018
        • GSK Investigational Site
      • Tokyo, Japan, 142-8666
        • GSK Investigational Site
      • Tokyo, Japan, 173-8606
        • GSK Investigational Site
      • Tokyo, Japan, 105-0003
        • GSK Investigational Site
  • Poland
      • ?Od?, Poland, 90-153
        • GSK Investigational Site
      • Gdansk, Poland, 80-214
        • GSK Investigational Site
      • Lodz, Poland, 92-213
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08025
        • GSK Investigational Site
      • Gerona, Spain, 17005
        • GSK Investigational Site
      • Valencia, Spain, 46015
        • GSK Investigational Site
  • United States
    • California
      • La Jolla, California, United States, 92037
        • GSK Investigational Site
      • Newport Beach, California, United States, 92663
        • GSK Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 71105
        • GSK Investigational Site
      • Colorado Springs, Colorado, United States, 80923
        • GSK Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • GSK Investigational Site
    • Florida
      • Homestead, Florida, United States, 33032
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32209
        • GSK Investigational Site
      • Miami, Florida, United States, 33125
        • GSK Investigational Site
      • Plantation, Florida, United States, 33317
        • GSK Investigational Site
    • Georgia
      • Adairsville, Georgia, United States, 30103
        • GSK Investigational Site
      • Columbus, Georgia, United States, 31904
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • GSK Investigational Site
      • Owensboro, Kentucky, United States, 42301
        • GSK Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 34452
        • GSK Investigational Site
    • Maryland
      • Glenn Dale, Maryland, United States, 20769
        • GSK Investigational Site
      • Towson, Maryland, United States, 21204
        • GSK Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • GSK Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • GSK Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • GSK Investigational Site
    • New Jersey
      • Linwood, New Jersey, United States, 08221
        • GSK Investigational Site
    • New York
      • Rochester, New York, United States, 14607
        • GSK Investigational Site
      • Schenectady, New York, United States, 12308
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19141
        • GSK Investigational Site
    • South Carolina
      • Union, South Carolina, United States, 29379
        • GSK Investigational Site
    • Texas
      • Cypress, Texas, United States, 77429
        • GSK Investigational Site
      • Kerrville, Texas, United States, 78028
        • GSK Investigational Site
      • McKinney, Texas, United States, 75069
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Group 1
Participants with a clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care.
Drug: Mepolizumab
Mepolizumab will be prescribed based on physician decision.
Other Names:
  • NUCALA
Other: Spirometry
Lung function via spirometry will be collected.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At month 12
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.
At month 12
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
At month 12
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
Baseline and at month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 219871

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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