drugset / Trial / NCT04276233

Efficacy and Safety Study of Mepolizumab 100 Milligram (mg) Subcutaneous (SC) in Indian Participants Aged Greater Than or Equal to (>=) 18 Years With Severe Eosinophilic Asthma

NCT04276233

Phase 4 Completed 100 enrolled GlaxoSmithKline Tech Observer · collab
NaSingle-groupOpen-labelTreatment

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 participants aged 18 years or above with severe eosinophilic asthma. After the first dose of mepolizumab, participants will receive 5 more doses of mepolizumab at 4 weekly intervals. Following the last dose of mepolizumab, the end of the study Visit will occur 4 weeks later. During the treatment period, OCS use and dose adjustment in participants will be as per the investigator's discretion and clinical practice.

Timeline

Start
2021-06-29
Primary completion
2023-10-28
Completion
2023-10-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Mepolizumab Monoclonal antibody 100 mg Subcutaneous
Background Salbutamol Unknown

Indications