Back to resultsREIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study (REIMAGINE)
Primary Purpose
Asthma
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Mepolizumab
Spirometry
Sponsored by
About this trial
This is an interventional other trial for Asthma focused on measuring Severe asthma, Eosinophilic phenotype, Oral corticosteroids (OCS), Asthma exacerbations, Clinical remission, NUCALA, Mepolizumab
Eligibility Criteria
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. 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All Participants
Arm Description
All participants with clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Percentage of Participants Achieving Oral corticosteroids (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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06041386
Brief Title
REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study
Acronym
REIMAGINE
Official Title
A Prospective, Real-World, Interventional Study To Evaluate The Effect Of Mepolizumab On Achieving Clinical Remission In Participants With Severe Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 16, 2023 (Anticipated)
Primary Completion Date
July 27, 2026 (Anticipated)
Study Completion Date
July 27, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Severe asthma, Eosinophilic phenotype, Oral corticosteroids (OCS), Asthma exacerbations, Clinical remission, NUCALA, Mepolizumab
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
There will be no masking in this study.
Allocation
N/A
Enrollment
336 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All Participants
Arm Type
Other
Arm Description
All participants with clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care.
Intervention Type
Drug
Intervention Name(s)
Mepolizumab
Other Intervention Name(s)
NUCALA
Intervention Description
Mepolizumab will be prescribed based on physician decision.
Intervention Type
Other
Intervention Name(s)
Spirometry
Intervention Description
Lung function via spirometry will be collected.
Primary Outcome Measure Information:
Title
Percentage (%) of Participants Achieving 4-Component Clinical Remission
Description
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.
Time Frame
At month 12
Secondary Outcome Measure Information:
Title
Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits
Description
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.
Time Frame
At month 12
Title
Percentage of Participants Achieving Oral corticosteroids (OCS) Sparing Remission
Description
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.
Time Frame
At month 12
Title
Percentage of Participants Achieving 3-Component Clinical Remission
Description
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.
Time Frame
At month 12
Title
Mean Change from Baseline in Mini-Asthma Quality of Life Questionnaire (AQLQ) Overall Score
Description
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.
Time Frame
Baseline and at month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Learn more about this trial
REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study
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