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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06041386

Collaborator

(none)

336

Enrollment

Arm

32.3

Anticipated Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Mepolizumab Other: Spirometry	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

336 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

There will be no masking in this study.

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Nov 16, 2023

Anticipated Primary Completion Date :

Jul 27, 2026

Anticipated Study Completion Date :

Jul 27, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: All Participants All participants with 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.

Arm

Intervention/Treatment

Other: All Participants

All participants with 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.

Outcome Measures

Primary Outcome Measures

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

Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits [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 Oral corticosteroids (OCS) Sparing Remission [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.