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

NCT06041386 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 219871
• Study Type: interventional
• Target: 336
• Locations: 9 countries
• Sites: 65

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).

Conditions

Asthma

Keywords

Severe asthma; Eosinophilic phenotype; Oral corticosteroids (OCS); Asthma exacerbations; Clinical remission; NUCALA; Mepolizumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits

  At month 12

• Percentage of Participants Achieving OCS Sparing Remission

  At month 12

• Percentage of Participants Achieving 3-Component Clinical Remission

  At month 12

• Mean Change from Baseline in Mini-Asthma Quality of Life Questionnaire (AQLQ) Overall Score

  Baseline and at month 12

Study Arms (1)

Group 1

OTHER

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

Drug: Mepolizumab; Other: Spirometry

Interventions

Mepolizumab DRUG

Mepolizumab will be prescribed based on physician decision.

Group 1

Spirometry OTHER

Lung function via spirometry will be collected.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (65)

GSK Investigational Site

La Jolla, California, 92037, United States

Location

GSK Investigational Site

Newport Beach, California, 92663, United States

Location

GSK Investigational Site

Aurora, Colorado, 71105, United States

Location

GSK Investigational Site

Colorado Springs, Colorado, 80923, United States

Location

GSK Investigational Site

New Haven, Connecticut, 06510, United States

Location

GSK Investigational Site

Homestead, Florida, 33032, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32209, United States

Location

GSK Investigational Site

Miami, Florida, 33125, United States

Location

GSK Investigational Site

Plantation, Florida, 33317, United States

Location

GSK Investigational Site

Adairsville, Georgia, 30103, United States

Location

GSK Investigational Site

Columbus, Georgia, 31904, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40509, United States

Location

GSK Investigational Site

Owensboro, Kentucky, 42301, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 34452, United States

Location

GSK Investigational Site

Glenn Dale, Maryland, 20769, United States

Location

GSK Investigational Site

Towson, Maryland, 21204, United States

Location

GSK Investigational Site

Ann Arbor, Michigan, 48103, United States

Location

GSK Investigational Site

Rochester, Minnesota, 55905, United States

Location

GSK Investigational Site

Henderson, Nevada, 89052, United States

Location

GSK Investigational Site

Linwood, New Jersey, 08221, United States

Location

GSK Investigational Site

Rochester, New York, 14607, United States

Location

GSK Investigational Site

Schenectady, New York, 12308, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19140, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19141, United States

Location

GSK Investigational Site

Union, South Carolina, 29379, United States

Location

GSK Investigational Site

Cypress, Texas, 77429, United States

Location

GSK Investigational Site

Kerrville, Texas, 78028, United States

Location

GSK Investigational Site

McKinney, Texas, 75069, United States

Location

GSK Investigational Site

Kortrijk, 8500, Belgium

Location

GSK Investigational Site

Liège, 4000, Belgium

Location

GSK Investigational Site

Calgary, Alberta, T3B0M3, Canada

Location

GSK Investigational Site

Calgary, Alberta, Canada

Location

GSK Investigational Site

Winnipeg, Manitoba, R3L 1Z5, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 1E2, Canada

Location

GSK Investigational Site

Brest, 29200, France

Location

GSK Investigational Site

Cannes, 06614, France

Location

GSK Investigational Site

Lille, 59000, France

Location

GSK Investigational Site

Lyon, 69004, France

Location

GSK Investigational Site

Strasbourg, 67091, France

Location

GSK Investigational Site

Toulouse, 31059, France

Location

GSK Investigational Site

Aachen, 52074, Germany

Location

GSK Investigational Site

Bonn, 53119, Germany

Location

GSK Investigational Site

Darmstadt, 64283, Germany

Location

GSK Investigational Site

Frankfurt, 60389, Germany

Location

GSK Investigational Site

Hohenstein-Ernsttal, 9337, Germany

Location

GSK Investigational Site

Schleswig, 53123, Germany

Location

GSK Investigational Site

Genova, 16132, Italy

Location

GSK Investigational Site

Monserrato CA, 09042, Italy

Location

GSK Investigational Site

Napoli, 80131, Italy

Location

GSK Investigational Site

Pieve Di Soligo TV, 131044, Italy

Location

GSK Investigational Site

Roma, 00128, Italy

Location

GSK Investigational Site

Roma, 161, Italy

Location

GSK Investigational Site

Rozzano, 20089, Italy

Location

GSK Investigational Site

Verona, 37126, Italy

Location

GSK Investigational Site

Gifu, 509-6134, Japan

Location

GSK Investigational Site

Kagawa, 760-0018, Japan

Location

GSK Investigational Site

Tokyo, 105-0003, Japan

Location

GSK Investigational Site

Tokyo, 142-8666, Japan

Location

GSK Investigational Site

Tokyo, 173-8606, Japan

Location

GSK Investigational Site

?Od?, 90-153, Poland

Location

GSK Investigational Site

Gdansk, 80-214, Poland

Location

GSK Investigational Site

Lodz, 92-213, Poland

Location

GSK Investigational Site

Barcelona, 08025, Spain

Location

GSK Investigational Site

Girona, 17005, Spain

Location

GSK Investigational Site

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Asthma

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: There will be no masking in this study.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 18, 2023
• Study Start: March 20, 2024
• Primary Completion: January 31, 2025
• Study Completion (Estimated): June 14, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

FR (6); PL (3); JP (5); IT (8); DE (6); US (28); BE (2); CA (4); ES (3)