Summary:
This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to the study medication is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype.
Qualified Participants Must:
• Adult and adolescent participants more than or equal to 12 years of age, at the time of signing the informed consent/assent
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Participants who have a documented physician diagnosis of asthma for more than 2 years that meets the National Heart, Lung, and Blood Institute guidelines (NHLBI) or Global Initiative for Asthma (GINA) guidelines
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Participants receiving either mepolizumab 100 milligrams (mg) or benralizumab 30 mg for more than 12 months prior to screening and have a documented benefit to therapy assessed by either: (i) greater than 50% reduction in exacerbation frequency since initiating treatment, or (ii) greater than 50% reduction in maintenance OCS use since initiating treatment, or (iii) No exacerbations in the past 6 months whilst receiving anti-IL-5/5R therapy and an Asthma Control Questionnaire (ACQ)-5 score of less than or equal to less than 1.5 at screening
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A well-documented requirement for regular treatment with medium to high dose ICS in the 12 months prior to Visit 1 with or without maintenance OCS. The maintenance ICS dose must be greater than 440 micrograms (mcg) fluticasone propionate (FP) hydrofluoroalkane (HFA) product daily, or clinically comparable. Participants who are treated with medium dose ICS will also need to be treated with a LABA to qualify for inclusion
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Current treatment with at least one additional controller medication, besides ICS [for example (e.g.), LABA, LAMA, leukotriene receptor antagonist (LTRA), or theophylline]
Qualified Participants May Receive:
May be eligible for reimbursement for time and travel for study participation, if you qualify.