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

Last updated: February 25, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

4

Condition

Asthma

Treatment

Mepolizumab

Spirometry

Clinical Study ID

NCT06041386
219871
  • Ages > 18
  • All Genders

Study 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 severe asthma with an eosinophilic phenotype (SA-EP).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has a confirmed asthma diagnosis and has been prescribed NUCALA by theirphysician for the treatment of asthma, as per local label. NUCALA can be initiatedup 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 forcedexpiratory volume in 1 second (FEV1) and less than or equal to (≤)4 exacerbationsper 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

Exclusion Criteria:

  • Investigator concerns about participant's willingness to adhere to biologictreatment for any reason (e.g., cost, behavior, difficulty with access tohealthcare)

  • Participants currently on maintenance OCS or intramuscular corticosteroids.

  • Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumabwithin the 6 months prior to enrollment

  • Participants participating in an interventional study with a treatment intervention

Study Design

Total Participants: 336
Treatment Group(s): 2
Primary Treatment: Mepolizumab
Phase: 4
Study Start date:
March 20, 2024
Estimated Completion Date:
June 14, 2028

Connect with a study center

  • GSK Investigational Site

    Kortrijk, 8500
    Belgium

    Active - Recruiting

  • GSK Investigational Site

    LiEge, 4000
    Belgium

    Active - Recruiting

  • GSK Investigational Site

    Calgary, Alberta T3B0M3
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Toronto, Ontario M5G 1E2
    Canada

    Active - Recruiting

  • GSK Investigational Site

    St-Charles-Borromee, Quebec J6E 2B4
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Brest, 29200
    France

    Active - Recruiting

  • GSK Investigational Site

    Cannes, 06614
    France

    Active - Recruiting

  • GSK Investigational Site

    Lille, 59000
    France

    Active - Recruiting

  • GSK Investigational Site

    Lyon, 69004
    France

    Active - Recruiting

  • GSK Investigational Site

    Strasbourg, 67091
    France

    Active - Recruiting

  • GSK Investigational Site

    Toulouse cedex 9, 31059
    France

    Active - Recruiting

  • GSK Investigational Site

    Aachen, 52074
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Bonn, 53119
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Darmstadt, 64283
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Frankfurt, 60596
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Hohenstein-Ernsttal, 9337
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Schleswig, 53123
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Genova, 16132
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Monserrato CA, 09042
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Napoli, 80131
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Pieve Di Soligo TV, 131044
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Roma, 161
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Rozzano, 20089
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Verona, 37126
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Gifu, 509-6134
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Kagawa, 760-0018
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Tokyo, 142-8666
    Japan

    Active - Recruiting

  • GSK Investigational Site

    ?Od?, 90-153
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Lodz, 92-213
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Barcelona, 08025
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Gerona, 17005
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Valencia, 46015
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • GSK Investigational Site

    La Jolla, California 92037
    United States

    Active - Recruiting

  • GSK Investigational Site

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • GSK Investigational Site

    Aurora, Colorado 71105
    United States

    Active - Recruiting

  • GSK Investigational Site

    Colorado Springs, Colorado 80923
    United States

    Active - Recruiting

  • GSK Investigational Site

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • GSK Investigational Site

    Homestead, Florida 33032
    United States

    Active - Recruiting

  • GSK Investigational Site

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • GSK Investigational Site

    Miami, Florida 33125
    United States

    Active - Recruiting

  • GSK Investigational Site

    Tallahassee, Florida 32308
    United States

    Active - Recruiting

  • GSK Investigational Site

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • GSK Investigational Site

    Lexington, Kentucky 40509
    United States

    Active - Recruiting

  • GSK Investigational Site

    Owensboro, Kentucky 42301
    United States

    Active - Recruiting

  • GSK Investigational Site

    New Orleans, Louisiana 34452
    United States

    Active - Recruiting

  • GSK Investigational Site

    Glenn Dale, Maryland 20769
    United States

    Active - Recruiting

  • GSK Investigational Site

    Towson, Maryland 21204
    United States

    Active - Recruiting

  • GSK Investigational Site

    Ann Arbor, Michigan 48103
    United States

    Active - Recruiting

  • GSK Investigational Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • GSK Investigational Site

    Henderson, Nevada 89052
    United States

    Active - Recruiting

  • GSK Investigational Site

    Linwood, New Jersey 08221
    United States

    Active - Recruiting

  • GSK Investigational Site

    Marlton, New Jersey 08053
    United States

    Active - Recruiting

  • GSK Investigational Site

    Schenectady, New York 12308
    United States

    Active - Recruiting

  • GSK Investigational Site

    Asheville, North Carolina 28801
    United States

    Active - Recruiting

  • GSK Investigational Site

    Philadelphia, Pennsylvania 19141
    United States

    Active - Recruiting

  • GSK Investigational Site

    Cypress, Texas 77429
    United States

    Active - Recruiting

  • GSK Investigational Site

    Kerrville, Texas 78028
    United States

    Active - Recruiting

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