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

Asthma Clinical Trial

— REIMAGINE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06041386
• Other study ID #: 219871
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 16, 2023
• Est. completion date: July 27, 2026

Study information

• Verified date: September 2023
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 336
• Est. completion date: July 27, 2026
• Est. primary completion date: July 27, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Mepolizumab
Mepolizumab will be prescribed based on physician decision.

Other:
• Spirometry
Lung function via spirometry will be collected.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.	At month 12
Secondary	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
Secondary	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