A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.
Completed · Phase 2 · Has a placebo group
Conditions studied: Alpha 1-Antitrypsin Deficiency, Emphysema, COPD
In brief
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.
Key facts
- Study ID
- NCT03636347
- Run by
- Mereo BioPharma
- People needed
- 99
- Starts
- 2018-10-29
- Expected to finish
- 2022-03-30
- Last updated by the study team
- 2022-04-14
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify 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
Where it is running
- University of Alabama, Birmingham (UAB) — Birmingham, Alabama, United States
- UCLA Medical Center — Los Angeles, California, United States
- UC Davis Medical Centre — Sacramento, California, United States
- PMG Research of Wilmington — Wilmington, North Carolina, United States
- UZ Gent — Ghent, Belgium
- UZ Leuven — Leuven, Belgium
- The University Lung Clinic — Edmonton, Alberta, Canada
- Centre for Heart Lung Innovation, St Pauls Hospital — Vancouver, British Columbia, Canada
- Inspiration Research Ltd — Toronto, Ontario, Canada
- University of Saskatchewan Royal University Hospital — Saskatoon, Saskatchewan, Canada
- Aarhus Universitetshospital — Aarhus, Denmark
- Gentofte Hospital — Hellerup, Denmark
- Synddansk Universitet (SDU) - Odense University — Odense, Denmark
- Instytut Gruzilicy Chorob Pluc — Warsaw, Poland
- Hospital Univ Clinico San Carlos — Madrid, Spain
- Hospital Sierrallana — Torrelavega, Spain
- CTC Gothia Forum Sahlgrenska University Hospital — Gothenburg, Sweden
- Lund University Hospital — Lund, Sweden
- University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom
- Cambridge University Hospitals Foundation NHS Trust — Cambridge, United Kingdom
- University Hospital Coventry and Warwickshire — Coventry, United Kingdom
- Royal Infirmary of Edinburgh — Edinburgh, United Kingdom
- Royal Devon and Exeter NHS Trust — Exeter, United Kingdom
- University Hospitals of Leicester NHS Trust — Leicester, United Kingdom
- Royal Brompton Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
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