A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- placebo-controlled, dose ascending, sequential group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Double-blind
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo oral tablet |
|
|
|
Active Comparator Alvelestat oral tablet - dose 1 |
MPH966 |
|
|
Active Comparator Alvelestat oral tablet - dose 2 |
MPH966 |
|
More Details
- Status
- Completed
- Sponsor
- Mereo BioPharma