ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Prospective, Real-World, Interventional Study To Evaluate The Effect Of Mepolizumab On Achieving Clinical Remission In Participants With Severe Asthma

Quick Facts

Study Start:2024-03-20
Study Completion:2028-06-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06041386

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * No NUCALA use in the 6 months prior to enrollment.
  3. * 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.
  4. * Other local prescription criteria of NUCALA not described above at NUCALA initiation (e.g., local reimbursement criteria).
  5. * Written informed consent
  1. * Investigator concerns about participant's willingness to adhere to biologic treatment for any reason (e.g., cost, behavior, difficulty with access to healthcare)
  2. * Participants currently on maintenance OCS or intramuscular corticosteroids.
  3. * Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment
  4. * Participants participating in an interventional study with a treatment intervention

Contacts and Locations

Principal Investigator

GSK Clinical Trials
STUDY_DIRECTOR
GlaxoSmithKline

Study Locations (Sites)

GSK Investigational Site
Little Rock, Arkansas, 72205
United States
GSK Investigational Site
La Jolla, California, 92037
United States
GSK Investigational Site
Newport Beach, California, 92663
United States
GSK Investigational Site
Aurora, Colorado, 71105
United States
GSK Investigational Site
Colorado Springs, Colorado, 80923
United States
GSK Investigational Site
New Haven, Connecticut, 06510
United States
GSK Investigational Site
Homestead, Florida, 33032
United States
GSK Investigational Site
Jacksonville, Florida, 32209
United States
GSK Investigational Site
Miami, Florida, 33125
United States
GSK Investigational Site
Tallahassee, Florida, 32308
United States
GSK Investigational Site
Columbus, Georgia, 31904
United States
GSK Investigational Site
Lexington, Kentucky, 40509
United States
GSK Investigational Site
Owensboro, Kentucky, 42301
United States
GSK Investigational Site
New Orleans, Louisiana, 34452
United States
GSK Investigational Site
Glenn Dale, Maryland, 20769
United States
GSK Investigational Site
Towson, Maryland, 21204
United States
GSK Investigational Site
Ann Arbor, Michigan, 48103
United States
GSK Investigational Site
Rochester, Minnesota, 55905
United States
GSK Investigational Site
Henderson, Nevada, 89052
United States
GSK Investigational Site
Linwood, New Jersey, 08221
United States
GSK Investigational Site
Marlton, New Jersey, 08053
United States
GSK Investigational Site
Rochester, New York, 14607
United States
GSK Investigational Site
Schenectady, New York, 12308
United States
GSK Investigational Site
Asheville, North Carolina, 28801
United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19141
United States
GSK Investigational Site
Cypress, Texas, 77429
United States
GSK Investigational Site
Kerrville, Texas, 78028
United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

  • GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-20
Study Completion Date2028-06-14

Study Record Updates

Study Start Date2024-03-20
Study Completion Date2028-06-14

Terms related to this study

Keywords Provided by Researchers

  • Severe asthma
  • Eosinophilic phenotype
  • Oral corticosteroids (OCS)
  • Asthma exacerbations
  • Clinical remission
  • NUCALA
  • Mepolizumab

Additional Relevant MeSH Terms

  • Asthma