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

219871

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).

2023-11-16

2026-07-27

2026-07-27

Not yet recruiting

Early phase I

336

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. * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'There will be no masking in this study.'}}, 'enrollmentInfo': {'count': 336, 'type': 'ESTIMATED'}}

2023-09-18