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

Status:	Recruiting
Conditions:	Chronic Obstructive Pulmonary Disease
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - 75
Updated:	3/7/2019
Start Date:	October 31, 2018
End Date:	October 30, 2019
Contact:	Ian Hodgson, PhD
Email:	enquiries@mereobiopharma.com
Phone:	+44 (0)333 0237 300

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 (PiZZ or Null) Antitrypsin Deficiency

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 or null 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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

We found this trial at

sites

University of Alabama at Birmingham (UAB)

Birmingham, Alabama 35294

from

Birmingham, AL