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

GlaxoSmithKline (GSK)

Status and phase

Not yet enrolling

Phase 4

Conditions

Asthma

Treatments

Other: Spirometry

Drug: Mepolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06041386

219871

Details and patient eligibility

About

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).

Enrollment

336 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
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.