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

NCT ID: NCT06041386

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2028-06-14

Brief Summary

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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).

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

There will be no masking in this study.

Study Groups

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Group 1

Participants with a clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care.

Group Type OTHER

Mepolizumab

Intervention Type DRUG

Mepolizumab will be prescribed based on physician decision.

Spirometry

Intervention Type OTHER

Lung function via spirometry will be collected.

Interventions

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Mepolizumab

Mepolizumab will be prescribed based on physician decision.

Intervention Type DRUG

Spirometry

Lung function via spirometry will be collected.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

La Jolla, California, United States

Site Status

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Newport Beach, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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New Haven, Connecticut, United States

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Homestead, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Plantation, Florida, United States

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Adairsville, Georgia, United States

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Columbus, Georgia, United States

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Lexington, Kentucky, United States

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Owensboro, Kentucky, United States

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New Orleans, Louisiana, United States

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Glenn Dale, Maryland, United States

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Towson, Maryland, United States

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Ann Arbor, Michigan, United States

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Rochester, Minnesota, United States

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Henderson, Nevada, United States

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Linwood, New Jersey, United States

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Rochester, New York, United States

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Schenectady, New York, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Union, South Carolina, United States

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Cypress, Texas, United States

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Kerrville, Texas, United States

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McKinney, Texas, United States

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Kortrijk, , Belgium

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Liège, , Belgium

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Calgary, Alberta, Canada

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Calgary, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Toronto, Ontario, Canada

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Brest, , France

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Cannes, , France

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Lille, , France

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Lyon, , France

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Strasbourg, , France

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Toulouse, , France

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Aachen, , Germany

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Bonn, , Germany

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Darmstadt, , Germany

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Frankfurt, , Germany

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Hohenstein-Ernsttal, , Germany

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Schleswig, , Germany

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Genova, , Italy

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Monserrato CA, , Italy

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Napoli, , Italy

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Pieve Di Soligo TV, , Italy

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Roma, , Italy

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Roma, , Italy

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Rozzano, , Italy

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Verona, , Italy

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Gifu, , Japan

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Kagawa, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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?Od?, , Poland

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Gdansk, , Poland

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Lodz, , Poland

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GSK Investigational Site

Barcelona, , Spain

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GSK Investigational Site

Girona, , Spain

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GSK Investigational Site

Valencia, , Spain

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Countries

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United States Belgium Canada France Germany Italy Japan Poland Spain

Other Identifiers

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219871

Identifier Type: -

Identifier Source: org_study_id

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