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

Running, not enrolling · Phase 4

Conditions studied: Asthma

In brief

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).

Key facts

Study ID

NCT06041386

Run by

GlaxoSmithKline

People needed

336

Starts

2024-03-20

Expected to finish

2028-06-14

Last updated by the study team

2025-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Bonn, Germany
• GSK Investigational Site — Darmstadt, Germany
• GSK Investigational Site — Frankfurt, Germany
• GSK Investigational Site — Hohenstein-Ernsttal, Germany
• GSK Investigational Site — Schleswig, Germany
• GSK Investigational Site — Genova, Italy
• GSK Investigational Site — Monserrato CA, Italy
• GSK Investigational Site — Naples, Italy
• GSK Investigational Site — Pieve Di Soligo TV, Italy
• GSK Investigational Site — Roma, Italy
• GSK Investigational Site — Roma, Italy
• GSK Investigational Site — Rozzano, Italy
• GSK Investigational Site — Verona, Italy
• GSK Investigational Site — Gifu, Japan
• GSK Investigational Site — Kagawa, Japan
• GSK Investigational Site — Tokyo, Japan
• GSK Investigational Site — Tokyo, Japan
• GSK Investigational Site — Tokyo, Japan
• GSK Investigational Site — ?Od?, Poland
• GSK Investigational Site — Gdansk, Poland
• GSK Investigational Site — Lodz, Poland
• GSK Investigational Site — Barcelona, Spain
• GSK Investigational Site — Girona, Spain
• GSK Investigational Site — Valencia, Spain
• GSK Investigational Site — Aachen, Germany

Full record on ClinicalTrials.gov

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