CompletedPhase 2

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

United States, Belgium99 participantsStarted 2018-10-29

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion Criteria: * Patients with a confirmed diagnosis of alpha-1-anti-trypsin deficiency and a PiZZ, null or other rare geno/phenotype and serum anti-alpha1 antitrypsin levels of less than 11uM * FEV1 ≥20% 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

What they're measuring

Change from baseline on blood biomarkers of neutrophil elastase activity compared to baseline and placebo

Timeframe: 12 weeks

Trial details

NCT IDNCT03636347

SponsorMereo BioPharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-02

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