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Evaluating Mepolizumab for Clinical Remission in Severe Asthma

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

PHASE4 · GlaxoSmithKline · NCT06041386

This study is testing if the asthma medication mepolizumab can help adults with severe asthma feel better and reduce their symptoms.

Quick facts

PhasePHASE4
Study typeInterventional
Enrollment336 (estimated)
Ages18 Years and up
SexAll
SponsorGlaxoSmithKline (industry)
Drugs / interventionsomalizumab, reslizumab, dupilumab, tezepelumab, benralizumab, mepolizumab
Locations66 sites (Little Rock, Arkansas and 65 other locations)
Trial IDNCT06041386 on ClinicalTrials.gov

What this trial studies

This prospective, real-world, single-arm study aims to assess the effectiveness of mepolizumab (NUCALA) in achieving clinical remission in adults with severe asthma characterized by an eosinophilic phenotype. Participants will be treated with mepolizumab and monitored for asthma exacerbations and lung function improvements. The study will take place across multiple global sites, focusing on patients who have not used mepolizumab in the past six months and meet specific lung function criteria.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed diagnosis of severe asthma and an eosinophilic phenotype who have been prescribed NUCALA.

Not a fit: Patients currently on maintenance oral corticosteroids or other biologic treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and remission of severe asthma for patients, reducing the need for oral corticosteroids.

How similar studies have performed: Other studies have shown positive outcomes with mepolizumab in similar patient populations, indicating a promising approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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 this trial is running

Little Rock, Arkansas and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Asthma, Severe asthma, Eosinophilic phenotype, Oral corticosteroids, Asthma exacerbations, Clinical remission, NUCALA, Mepolizumab

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.