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
Recruitment complete
Recruitment complete
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:
Enrollment:
336
Primary completion date:
2025-31-01
Observational study model:
Not applicable
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
Showing 1 - 6 of 73 Results
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruitment complete
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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