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OpenTrials
Completed

NCT Number: NCT03636347

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

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.

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Key information

Conditions

Alpha 1-Antitrypsin Deficiency COPD Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Disease Attributes Emphysema Genetic Diseases, Inborn Liver Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Subcutaneous Emphysema

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UZ Gent, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo oral tablet

Drug

twice daily administration

Alvelestat oral tablet - dose 1

Drug

twice daily administration

Other names: MPH966

Alvelestat oral tablet - dose 2

Drug

twice daily administration

Other names: MPH966

Primary outcomes

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

    Time frame: 12 weeks

    Within-individual change from baseline up to end of treatment in:

    • Blood neutrophil elastase activity
    • Blood Aα-Val 360 levels
    • Plasma desmosine/isodesmosine levels

Secondary outcomes

  1. Change from baseline on other blood biomarkers of neutrophil elastase activity

    Time frame: 12 weeks

    Frequency of neutrophil elastase levels below the limit of detection from baseline to end of treatment

Other outcomes

  1. Change from baseline in St. George's Respiratory Questionnaire (SGRQ-C) to end of treatment

    Time frame: 12 weeks

    Total score

  2. Change from baseline in pulmonary function

    Time frame: 12 weeks

    Change from baseline in forced expiratory volume in 1 second (FEV1)

Sponsors and collaborators

Lead sponsor

Mereo BioPharma

Industry

Collaborators

  • Syneos Health

Registry information

Official study title

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 Antitrypsin Deficiency.

Acronym: ASTRAEUS

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 17, 2018
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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