Last updated: 07/30/2025 19:30:07
REIMAGINE - Real world EvaluatIon of Mepolizumab in severe Asthma achievinG on treatment clinIcal remissioN, a prospEctive studyREIMAGINE
GSK study ID
219871
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Active, not recruiting
Active, not recruiting
Trial overview
Official title: A Prospective, Real-World, Interventional Study To Evaluate The Effect Of Mepolizumab On Achieving Clinical Remission In Participants With Severe Asthma
Trial description: 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).
Primary purpose:
Other
Trial design:
Single Group
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Percentage (%) of Participants Achieving 4-Component Clinical Remission
Timeframe: At month 12
Secondary outcomes:
Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits
Timeframe: At month 12
Percentage of Participants Achieving OCS Sparing Remission
Timeframe: At month 12
Percentage of Participants Achieving 3-Component Clinical Remission
Timeframe: At month 12
Mean Change from Baseline in Mini-Asthma Quality of Life Questionnaire (AQLQ) Overall Score
Timeframe: Baseline and at month 12
Interventions:
Drug: Mepolizumab
Other: Spirometry
Enrollment:
336
Observational study model:
Not applicable
Primary completion date:
2025-31-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
March 2024 to June 2028
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion 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 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
Trial location(s)
Location
GSK Investigational Site
Asheville, NC, United States, 28801
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Colorado Springs, CO, United States, 80923
Status
Study Complete
Location
GSK Investigational Site
Glenn Dale, MD, United States, 20769
Status
Recruitment Complete
Location
GSK Investigational Site
Hohenstein-Ernsttal, Germany, 9337
Status
Recruitment Complete
Location
GSK Investigational Site
Homestead, FL, United States, 33032
Status
Recruitment Complete
Location
GSK Investigational Site
La Jolla, CA, United States, 92037
Status
Recruitment Complete
Location
GSK Investigational Site
Lexington, KY, United States, 40509
Status
Recruitment Complete
Location
GSK Investigational Site
Linwood, New Jersey, United States, 08221
Status
Recruitment Complete
Location
GSK Investigational Site
Little Rock, AR, United States, 72205
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Newport Beach, CA, United States, 92663
Status
Recruitment Complete
Location
GSK Investigational Site
Owensboro, KY, United States, 42301
Status
Recruitment Complete
Location
GSK Investigational Site
Pieve di Soligo TV, Italy, 131044
Status
Recruitment Complete
Location
GSK Investigational Site
Rochester, NY, United States, 14607
Status
Recruitment Complete
Location
GSK Investigational Site
Tallahassee, FL, United States, 32308
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Aurora, CO, United States, 71105
Status
Recruitment Complete
Location
GSK Investigational Site
Cypress, TX, United States, 77429
Status
Recruitment Complete
Location
GSK Investigational Site
Henderson, NV, United States, 89052
Status
Recruitment Complete
Location
GSK Investigational Site
Jacksonville, FL, United States, 32209
Status
Recruitment Complete
Location
GSK Investigational Site
Kerrville, TX, United States, 78028
Status
Recruitment Complete
Location
GSK Investigational Site
Marlton, NJ, United States, 08053
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ann Arbor, MI, United States, 48103
Status
Recruitment Complete
Location
GSK Investigational Site
New Haven, CT, United States, 06510
Status
Recruitment Complete
Location
GSK Investigational Site
Philadelphia, PA, United States, 19141
Status
Study Complete
Location
GSK Investigational Site
Rochester, MN, United States, 55905
Status
Recruitment Complete
Location
GSK Investigational Site
St-Charles-Borromee, QC, Canada, J6E 2B4
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Towson, MD, United States, 21204
Status
Recruitment Complete
Location
GSK Investigational Site
New Orleans, LA, United States, 34452
Status
Recruitment Complete
Location
GSK Investigational Site
Philadelphia, PA, United States, 19140
Status
Recruitment Complete
Location
GSK Investigational Site
Schenectady, NY, United States, 12308
Status
Recruitment Complete
Location
GSK Investigational Site
Plantation, FL, United States, 33317
Status
Recruitment Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Active, not recruiting
Actual primary completion date
2025-31-01
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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