NCT03636347

A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.

A Phase 2, Proof-of-concept, Multicentre, Double-blind, Randomised, Dose-ascending, Sequential Group, Placebo-controlled Study to Evaluate the Mechanistic Effect, Safety, and Tolerability of 12 Weeks Twice Daily Oral Administration of Alvelestat (MPH966) in Participants With Alpha-1 Antitrypsin Deficiency.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Mereo BioPharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect of alvelestat (an oral neutrophil elastase inhibitor) on blood and sputum biomarkers in patients with PiZZ, null or rare variant phenotype/genotype alpha-1 anti-trypsin deficient lung disease. Change in a number of different blood and sputum biomarkers related to lung damage, inflammation and elastase activity will be measured over a 12 week period. The effect on lung function and respiratory symptoms will also be measured.

Conditions

• Alpha 1-Antitrypsin Deficiency
• Emphysema
• COPD

Interventions

Type	Name	Description
DRUG	Placebo Oral Tablet	twice daily administration
DRUG	Alvelestat oral tablet - dose 1	twice daily administration
DRUG	Alvelestat oral tablet - dose 2	twice daily administration

Timeline

• Start date: 2018-10-29
• Primary completion: 2022-03-02
• Completion: 2022-03-30
• First posted: 2018-08-17
• Last updated: 2022-04-14

Locations

26 sites across 8 countries: United States, Belgium, Canada, Denmark, Poland, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study