Phase 4 Study of Mepolizumab 100 Milligram (mg) Subcutaneous (SC) in Indian Subjects Aged >=18 Years With Severe Eosinophilic Asthma Requiring Maintenance Oral Corticosteroids

• Status: Recruiting
• Trial end date: 2023-01-23

Summary

Mepolizumab is a humanized monoclonal antibody (IgG1, kappa) that blocks interleukin-5 (IL-5) thus inhibits production and survival of eosinophils. The aim of this phase 4, open-label, single-arm study is to evaluate the safety and efficacy of Mepolizumab 100 mg SC administered every 4 weeks in Indian subjects aged 18 years or above with severe eosinophilic asthma requiring oral corticosteroid (OCS) treatment to maintain asthma control. The study consists of four phases, OCS Optimization Phase (Week -8 to Week -3), an Induction Phase (Week 0 to Week 4), OCS Reduction Phase (Week 4 to Week 20) followed by Maintenance Phase (Week 20 to Week 24). In the Induction Phase subjects will be administered mepolizumab 100 mg subcutaneously every 4 weeks along with their Baseline asthma medications. This phase will allow sufficient time for subjects to achieve a decrease in the eosinophilic inflammation prior to the reduction in OCS. During the Optimization Phase, the investigator will adjust the OCS (prednisone/prednisolone) dose according to the Optimization titration schedule based on a review of Asthma Control Questionnaire (ACQ)-5 score and exacerbation. During the Reduction Phase, subjects will continue to receive 100 mg mepolizumab every 4 weeks and the OCS dose reduction will be done every 4 weeks using the reduction titration schedule based on a review of eDiary parameters recorded by the subject, the subjects' exacerbation history, and a review of the signs and symptoms of adrenal insufficiency. In the Maintenance Phase, subjects will be maintained during the last 4-weeks of the study without any further OCS dose adjustment.

• Phase: Phase 4

Details

• Lead Sponsor: GlaxoSmithKline
• Collaborator: Tech Observer
• Treatments: Albuterol; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone