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

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: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: Mepolizumab; Other: Spirometry

• Study Type: Interventional
• Enrollment (Estimated): 336
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Percentage (%) of Participants Achieving 4-Component Clinical Remission	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

Outcome Measure	Measure Description	Time Frame
Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits	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	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	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	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

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Actual): January 31, 2025
• Study Completion (Estimated): June 14, 2028

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Mepolizumab; Clinical remission; Eosinophilic phenotype; Severe asthma; NUCALA; Asthma exacerbations; Oral corticosteroids (OCS)
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID 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