Status:
ACTIVE_NOT_RECRUITING
REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 14 2028
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT06041386
Start Date
March 20 2024
End Date
June 14 2028
Last Update
August 1 2025
Active Locations (65)
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1
GSK Investigational Site
La Jolla, California, United States, 92037
2
GSK Investigational Site
Newport Beach, California, United States, 92663
3
GSK Investigational Site
Aurora, Colorado, United States, 71105
4
GSK Investigational Site
Colorado Springs, Colorado, United States, 80923