A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.
NCT ID: NCT03636347
Last Updated: 2022-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2018-10-29
2022-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo oral tablet
Placebo Oral Tablet
twice daily administration
Alvelestat oral tablet - dose 1
MPH966
Alvelestat oral tablet - dose 1
twice daily administration
Alvelestat oral tablet - dose 2
MPH966
Alvelestat oral tablet - dose 2
twice daily administration
Interventions
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Placebo Oral Tablet
twice daily administration
Alvelestat oral tablet - dose 1
twice daily administration
Alvelestat oral tablet - dose 2
twice daily administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* FEV1 ≥20% predicted
* Computerised tomography (CT) scan evidence of emphysema
* Non-smokers
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Syneos Health
OTHER
Mereo BioPharma
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Stockley, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Birmingham
Locations
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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
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Other Identifiers
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2018-001309-95
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MPH966-2-01
Identifier Type: -
Identifier Source: org_study_id
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