Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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.

Keywords

Alpha 1-Antitrypsin Deficiency Emphysema COPD PiZZ or Null Neutrophil elastase inhibitor Alpha-1 Alvelestat AZD9668 MPH966 Rare variant genotype Astraeus Alvelestat oral tablet - dose 1 Alvelestat oral tablet - dose 2

Eligibility

You can join if…

Open to people ages 18-75

  • Patients with a confirmed diagnosis of alpha-1-anti-trypsin deficiency and a PiZZ or null geno/phenotype and serum anti-alpha1 antitrypsin levels of less than 11uM
  • FEV1 ≥25% predicted
  • Computerised tomography (CT) scan evidence of emphysema
  • Non-smokers

You CAN'T join if...

  • Primary diagnosis of bronchiectasis
  • An ongoing acute exacerbation of the underlying lung disease
  • Underlying liver disease or abnormal liver function tests
  • Previous augmentation therapy within 6 months of dosing

Locations

  • UC Davis Medical Centre accepting new patients
    Sacramento California 95817 United States
  • UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mereo BioPharma
Links
Study Website Sign up for this study
ID
NCT03636347
Phase
Phase 2
Study Type
Interventional
Last Updated