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

GlaxoSmithKline (GSK) logo

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.

Trial design

336 participants in 1 patient group

All Participants
Other group
Description:
All participants with clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care.
Treatment:
Drug: Mepolizumab
Other: Spirometry

Trial contacts and locations

0

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Central trial contact

US GSK Clinical Trials Call Center; EU GSK Clinical Trials Call Center

Data sourced from clinicaltrials.gov

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