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

A Phase 4, Open-label, Single Arm, 24-week, Study to Evaluate the Safety and Efficacy of Mepolizumab 100 mg SC Administered Every 4 Weeks in Indian Participants Aged ≥18 Years With Severe Eosinophilic asthMa (PRISM)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Mepolizumab	Mepolizumab will be available as a lyophilized cake in sterile vials and will be reconstituted with sterile water for injection, just prior to use.
DRUG	Salbutamol	Salbutamol metered dose inhalers (MDIs) will be provided as rescue medication during treatment period.

Timeline

• Start date: 2021-06-29
• Primary completion: 2023-10-28
• Completion: 2023-10-28
• First posted: 2020-02-19
• Last updated: 2024-12-10
• Results posted: 2024-12-10

Locations

14 sites across 1 country: India