Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 10 for:    Alpha-1-proteinase inhibitor AND ELANE
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03636347
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Mereo BioPharma

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 or null 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.

Condition or disease Intervention/treatment Phase
Alpha 1-Antitrypsin Deficiency Emphysema COPD Drug: Placebo Oral Tablet Drug: Alvelestat oral tablet - dose 1 Drug: Alvelestat oral tablet - dose 2 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: placebo-controlled, dose ascending, sequential group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
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 (PiZZ or Null) Antitrypsin Deficiency
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : June 23, 2020
Estimated Study Completion Date : July 21, 2020


Arm Intervention/treatment
Placebo Comparator: Placebo oral tablet Drug: Placebo Oral Tablet
twice daily administration

Active Comparator: Alvelestat oral tablet - dose 1
MPH966
Drug: Alvelestat oral tablet - dose 1
twice daily administration
Other Name: MPH966

Active Comparator: Alvelestat oral tablet - dose 2
MPH966
Drug: Alvelestat oral tablet - dose 2
twice daily administration
Other Name: MPH966




Primary Outcome Measures :
  1. Change from baseline on blood biomarkers of neutrophil elastase activity [ Time Frame: 12 weeks ]
    Within-individual % change from baseline in plasma desmosine/isodesmosine at end of treatment compared to placebo


Secondary Outcome Measures :
  1. Change from baseline on other blood biomarkers of neutrophil elastase activity [ Time Frame: 12 weeks ]
    Overall change from baseline in plasma desmosine/isodesmosine


Other Outcome Measures:
  1. Change from baseline in St. George's Respiratory Questionnaire (SGRQ-C) at 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636347


Contacts
Layout table for location contacts
Contact: Ian Hodgson, PhD +44 (0)333 0237 300 enquiries@mereobiopharma.com
Contact: Jackie Parkin, MD enquiries@mereobiopharma.com

  Show 26 Study Locations
Sponsors and Collaborators
Mereo BioPharma
Syneos Health
Investigators
Layout table for investigator information
Principal Investigator: Robert Stockley, Prof. University of Birmingham

Layout table for additonal information
Responsible Party: Mereo BioPharma
ClinicalTrials.gov Identifier: NCT03636347     History of Changes
Other Study ID Numbers: MPH966-2-01
2018-001309-95 ( EudraCT Number )
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mereo BioPharma:
PiZZ or Null genotype
Neutrophil elastase inhibitor
Alpha-1
Alvelestat
AZD9668
MPH966
Additional relevant MeSH terms:
Layout table for MeSH terms
Alpha 1-Antitrypsin Deficiency
Alpha 1-Antitrypsin
Protein C Inhibitor
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Liver Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Molecular Mechanisms of Pharmacological Action