AsthmaPhase 4REIMAGINENCT06041386
REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study
A Phase 4 study testing Mepolizumab and Spirometry in people with Asthma, run by GlaxoSmithKline at 65 sites in 9 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Mepolizumab and Spirometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 65 sitesin 9 countries
- Study dates
- 20 Mar 2024to 14 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
65 sites in 9 countries.
65 sites in 9 countries
United States28 sites
GSK Investigational Site
Adairsville, Georgia, 30103
GSK Investigational Site
Ann Arbor, Michigan, 48103
GSK Investigational Site
Aurora, Colorado, 71105
GSK Investigational Site
Colorado Springs, Colorado, 80923
GSK Investigational Site
Columbus, Georgia, 31904
GSK Investigational Site
Cypress, Texas, 77429
GSK Investigational Site
Glenn Dale, Maryland, 20769
GSK Investigational Site
Henderson, Nevada, 89052
GSK Investigational Site
Homestead, Florida, 33032
GSK Investigational Site
Jacksonville, Florida, 32209
GSK Investigational Site
Kerrville, Texas, 78028
GSK Investigational Site
La Jolla, California, 92037
GSK Investigational Site
Lexington, Kentucky, 40509
GSK Investigational Site
Linwood, New Jersey, 08221
GSK Investigational Site
McKinney, Texas, 75069
GSK Investigational Site
Miami, Florida, 33125
GSK Investigational Site
New Haven, Connecticut, 06510
GSK Investigational Site
New Orleans, Louisiana, 34452
GSK Investigational Site
Newport Beach, California, 92663
GSK Investigational Site
Owensboro, Kentucky, 42301
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
GSK Investigational Site
Philadelphia, Pennsylvania, 19141
GSK Investigational Site
Plantation, Florida, 33317
GSK Investigational Site
Rochester, Minnesota, 55905
GSK Investigational Site
Rochester, New York, 14607
GSK Investigational Site
Schenectady, New York, 12308
GSK Investigational Site
Towson, Maryland, 21204
GSK Investigational Site
Union, South Carolina, 29379
Italy8 sites
GSK Investigational Site
Genova, 16132
GSK Investigational Site
Monserrato CA, 09042
GSK Investigational Site
Naples, 80131
GSK Investigational Site
Pieve Di Soligo TV, 131044
GSK Investigational Site
Roma, 00128
GSK Investigational Site
Roma, 161
GSK Investigational Site
Rozzano, 20089
GSK Investigational Site
Verona, 37126
France6 sites
GSK Investigational Site
Brest, 29200
GSK Investigational Site
Cannes, 06614
GSK Investigational Site
Lille, 59000
GSK Investigational Site
Lyon, 69004
GSK Investigational Site
Strasbourg, 67091
GSK Investigational Site
Toulouse, 31059
Germany6 sites
GSK Investigational Site
Aachen, 52074
GSK Investigational Site
Bonn, 53119
GSK Investigational Site
Darmstadt, 64283
GSK Investigational Site
Frankfurt, 60389
GSK Investigational Site
Hohenstein-Ernsttal, 9337
GSK Investigational Site
Schleswig, 53123
Japan5 sites
GSK Investigational Site
Gifu, 509-6134
GSK Investigational Site
Kagawa, 760-0018
GSK Investigational Site
Tokyo, 105-0003
GSK Investigational Site
Tokyo, 142-8666
GSK Investigational Site
Tokyo, 173-8606
Canada4 sites
GSK Investigational Site
Calgary, Alberta, T3B0M3
GSK Investigational Site
Calgary, Alberta
GSK Investigational Site
Toronto, Ontario, M5G 1E2
GSK Investigational Site
Winnipeg, Manitoba, R3L 1Z5
Poland3 sites
GSK Investigational Site
?Od?, 90-153
GSK Investigational Site
Gdansk, 80-214
GSK Investigational Site
Lodz, 92-213
Spain3 sites
GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
Girona, 17005
GSK Investigational Site
Valencia, 46015
Belgium2 sites
GSK Investigational Site
Kortrijk, 8500
GSK Investigational Site
Liège, 4000
About this study
Official title: A Prospective, Real-World, Interventional Study To Evaluate The Effect Of Mepolizumab On Achieving Clinical Remission In Participants With Severe Asthma
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).
- Conditions
- Asthma
- Being tested
- Mepolizumab, Spirometry
- Keywords
- Severe asthma, Eosinophilic phenotype, Oral corticosteroids (OCS), Asthma exacerbations, Clinical remission, NUCALA, Mepolizumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabDrug
Mepolizumab will be prescribed based on physician decision.
SpirometryOther
Lung function via spirometry will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Participants with a clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care. Receives: Drug: Mepolizumab; Other: Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of Participants Achieving 4-Component Clinical Remission
4-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an Asthma Control Test (ACT) (d) No clinically significant deterioration of lung function.
Measured: At month 12
Secondary outcomes (4)
Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits
CSE is defined as a deterioration in asthma requiring (1) the initiation of systemic corticosteroids and/or (2) an ER visit and/or hospital admission.
Measured: At month 12
Percentage of Participants Achieving OCS Sparing Remission
OCS sparing is defined as (a) No clinically significant asthma exacerbations during the period of interest (b) No OCS use for asthma at the time point of interest.
Measured: At month 12
Percentage of Participants Achieving 3-Component Clinical Remission
3-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an ACT
Measured: At month 12
Mean Change from Baseline in Mini-Asthma Quality of Life Questionnaire (AQLQ) Overall Score
The mini-AQLQ overall score is a reduced version of the AQLQ which includes 15 items. The minimally clinically important difference (MCID) is 0.5. The response options for each item are on an equidistant scale of 7 points, where 1 corresponds to the maximum disability and 7 to the absence of disability
Measured: Baseline and at month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start20 Mar 2024
- Primary completion31 Jan 2025
- Study completion14 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041386
- Sponsor's protocol ID
- 219871
- Acronym
- REIMAGINE
- Status last verified
- Jul 2025
- First submitted
- 6 Sep 2023
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Real-World, Interventional Study To Evaluate The Effect Of Mepolizumab On Achieving Clinical Remission In Participants With Severe Asthma
- ClinicalTrials.gov ID
- NCT06041386
- Acronym / sponsor ID
- REIMAGINE / 219871
- Conditions
- Asthma
- Keywords
- Severe asthma, Eosinophilic phenotype, Oral corticosteroids (OCS), Asthma exacerbations, Clinical remission, NUCALA, Mepolizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 14 Jun 2028 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Drug: Mepolizumab, Other: SpirometryParticipants with a clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MepolizumabMepolizumab will be prescribed based on physician decision. | Drug | Group 1 |
| SpirometryLung function via spirometry will be collected. | Other | Group 1 |
Primary outcome
Percentage (%) of Participants Achieving 4-Component Clinical Remission
Time frame: At month 12
4-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an Asthma Control Test (ACT) (d) No clinically significant deterioration of lung function.
4 secondary outcomes
Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits
Time frame: At month 12
Percentage of Participants Achieving OCS Sparing Remission
Time frame: At month 12
Percentage of Participants Achieving 3-Component Clinical Remission
Time frame: At month 12
Mean Change from Baseline in Mini-Asthma Quality of Life Questionnaire (AQLQ) Overall Score
Time frame: Baseline and at month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
65 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mepolizumab and Spirometry in people with Asthma, run by GlaxoSmithKline at 65 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Italy, France, Germany, Japan and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage (%) of Participants Achieving 4-Component Clinical Remission (time frame: At month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.