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

Mereo BioPharma

Status and phase: Completed; Phase 2

Conditions: Emphysema; COPD; Alpha 1-Antitrypsin Deficiency

Treatments: Drug: Alvelestat oral tablet - dose 1; Drug: Placebo Oral Tablet; Drug: Alvelestat oral tablet - dose 2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03636347

2018-001309-95 (EudraCT Number)

MPH966-2-01

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 3 patient groups, including a placebo group

Placebo oral tablet

Placebo Comparator group

Treatment:

Drug: Placebo Oral Tablet

Alvelestat oral tablet - dose 1

Active Comparator group

Description:

MPH966

Treatment:

Drug: Alvelestat oral tablet - dose 1

Alvelestat oral tablet - dose 2

Active Comparator group

Description:

MPH966

Treatment:

Drug: Alvelestat oral tablet - dose 2