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NCT03636347 Clinical Trial

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

COPD Clinical Trial

— ASTRAEUS  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03636347
Other study ID # MPH966-2-01
Secondary ID 2018-001309-95
Status Completed
Phase Phase 2
First received
Last updated
Start date October 29, 2018
Est. completion date March 30, 2022

Study information
Verified date April 2022
Source Mereo BioPharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date March 30, 2022
Est. primary completion date March 2, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo Oral Tablet
twice daily administration
• Alvelestat oral tablet - dose 1
twice daily administration
• Alvelestat oral tablet - dose 2
twice daily administration

Locations
Country Name City State
Belgium UZ Gent Gent
Belgium UZ Leuven Leuven
Canada The University Lung Clinic Edmonton Alberta
Canada University of Saskatchewan Royal University Hospital Saskatoon Saskatchewan
Canada Inspiration Research Ltd Toronto Ontario
Canada Centre for Heart Lung Innovation, St Pauls Hospital Vancouver British Columbia
Denmark Aarhus Universitetshospital Aarhus
Denmark Gentofte Hospital Hellerup
Denmark Synddansk Universitet (SDU) - Odense University Odense
Poland Instytut Gruzilicy Chorob Pluc Warsaw
Spain Hospital Univ Clinico San Carlos Madrid
Spain Hospital Sierrallana Torrelavega
Sweden CTC Gothia Forum Sahlgrenska University Hospital Gothenburg
Sweden Lund University Hospital Lund
United Kingdom 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 Southampton General Hospital Southampton
United States 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

Sponsors (2)
Lead Sponsor Collaborator
Mereo BioPharma Syneos Health

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Denmark,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Other Change from baseline in St. George's Respiratory Questionnaire (SGRQ-C) to end of treatment Total score 12 weeks
Other Change from baseline in pulmonary function Change from baseline in forced expiratory volume in 1 second (FEV1) 12 weeks
Primary Change from baseline on blood biomarkers of neutrophil elastase activity compared to baseline and placebo Within-individual change from baseline up to end of treatment in:
Blood neutrophil elastase activity
Blood Aa-Val 360 levels
Plasma desmosine/isodesmosine levels		 12 weeks
Secondary Change from baseline on other blood biomarkers of neutrophil elastase activity Frequency of neutrophil elastase levels below the limit of detection from baseline to end of treatment 12 weeks
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