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

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Brief Title

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

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.

Brief 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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change from baseline on blood biomarkers of neutrophil elastase activity

Secondary Outcome

 Change from baseline on other blood biomarkers of neutrophil elastase activity

Condition

Alpha 1-Antitrypsin Deficiency

Intervention

Placebo Oral Tablet

Study Arms / Comparison Groups

 Placebo oral tablet
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

165

Start Date

October 29, 2018

Completion Date

July 21, 2020

Primary Completion Date

June 23, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with a confirmed diagnosis of alpha-1-anti-trypsin deficiency and a PiZZ or
             null geno/phenotype and serum anti-alpha1 antitrypsin levels of less than 11uM

          -  FEV1 ≥25% 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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Robert Stockley, Prof., +44 (0)333 0237 300, [email protected]

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT03636347

Organization ID

MPH966-2-01

Secondary IDs

2018-001309-95

Responsible Party

Sponsor

Study Sponsor

Mereo BioPharma

Collaborators

 Syneos Health

Study Sponsor

Robert Stockley, Prof., Principal Investigator, University of Birmingham


Verification Date

May 2020