NCT04133909

Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Mepolizumab 100 mg SC as add-on Treatment in Participants With COPD Experiencing Frequent Exacerbations and Characterized by Eosinophil Levels (Study 208657)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 806 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD therapy. The maximum duration of participant participation is approximately 109 weeks, consisting of 2 screening visits (up to 3 weeks), a run-in period (up to 2 weeks), and an intervention period of at least 52 weeks and up to 104 weeks. 800 participants will be randomized in a 1:1 ratio to receive mepolizumab 100 milligrams (mg) or placebo every 4 weeks for at least 13 doses (52 weeks treatment period) up to a maximum of 26 doses (104 weeks treatment period). The number of randomized participants may increase up to approximately 1400.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
BIOLOGICAL	Mepolizumab	Mepolizumab was a sterile liquid formulation. It was administered as a subcutaneous injection (100 milligrams per milliliter \[mg/mL\]) delivered once every 4 weeks using a pre-filled safety syringe.
DRUG	Placebo	Placebo was a 0.9% sodium chloride solution. It was administered as a subcutaneous injection delivered once every 4 weeks using a pre-filled safety syringe.

Timeline

• Start date: 2019-10-30
• Primary completion: 2024-08-08
• Completion: 2024-08-08
• First posted: 2019-10-21
• Last updated: 2025-08-15
• Results posted: 2025-08-15

Locations

361 sites across 26 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Denmark, Estonia, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study