Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03679598) enrolled 63 people in total — 32 received a medicine called alvelestat (also known as MPH966) twice a day for 12 weeks, and 31 received a placebo (a dummy treatment with no active ingredient). The trial was set up to measure two main things: changes in a blood substance called desmosine/isodesmosine (a marker linked to tissue breakdown in the lungs) and how many participants experienced at least one unwanted health event (called a treatment-emergent adverse event) during the study. A number of additional blood markers related to inflammation and immune cell activity were also tracked as secondary measurements. The reported data shows that, for the primary blood marker (desmosine/isodesmosine), the within-individual percentage change was approximately 10.1% in the alvelestat group and 8.6% in the placebo group. Regarding unwanted health events, 25 out of 32 participants (about 78%) in the alvelestat group and 23 out of 31 participants (about 74%) in the placebo group experienced at least one such event during the study period. For the secondary blood markers, the reported data shows a range of small numerical changes across both groups — for example, one marker (NE activity) changed by approximately −16.8 units in the alvelestat group compared with +4.0 units in the placebo group, while other markers showed smaller or mixed differences. It is worth noting that the data as submitted does not clearly label each individual secondary marker result, so a full breakdown of every marker cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 COPD Trial, Completed
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- Adults aged 18 to 80 years old
- People who have a confirmed diagnosis of a specific type of Alpha-1 Antitrypsin Deficiency (a genetic condition affecting the lungs and liver), with certain specific genetic types (Pi*ZZ, Pi*SZ, Pi*null, or other rare types known to cause very low or poorly functioning AAT protein levels)
- People whose lung function test (a breathing test called FEV1) shows a result of at least 25% of what would be expected for a healthy person
- People who are either not currently receiving augmentation therapy (a protein replacement treatment) and have not received it in the 12 weeks before the screening visit, OR people who have been receiving weekly augmentation therapy infusions for at least 12 weeks before screening and plan to continue throughout the study
- People who are able to understand and agree to the study requirements by signing a consent form
- Male participants who agree to use highly effective contraception during the treatment period and for at least 4 days after the last dose, and who agree not to donate sperm during this time
- Female participants who are not pregnant and not breastfeeding, and who are either unable to become pregnant, or who agree to use effective contraception during the treatment period and for at least 4 days after the last dose
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People with certain milder genetic types of Alpha-1 Antitrypsin Deficiency (such as Pi*MZ, Pi*FM, Pi*MS, or Pi*SS) that are not independently known to cause emphysema (a type of lung damage)
- People with a diagnosed lung condition other than COPD, such as cystic fibrosis, widespread lung scarring, or significant bronchiectasis (a long-term lung condition causing widened airways)
- People who have had a flare-up of their lung condition requiring oral steroids or antibiotics within 4 weeks before the start of the study
- People with active or ongoing hepatitis (liver inflammation), including hepatitis B or hepatitis C, based on blood test results
- People with HIV infection, other immune system deficiencies, or a very low level of a specific type of white blood cell (neutrophils) on blood tests
- People with abnormal liver blood test results above certain levels (confirm specific thresholds with trial site)
- People with certain abnormal results on blood tests at the start of the study, including low platelet count, low albumin (a blood protein), abnormal blood clotting results, or elevated muscle enzyme levels (confirm specific thresholds with trial site)
- People with a history or current evidence of serious liver conditions such as cirrhosis, varicose veins in the oesophagus (oesophageal varices), fluid build-up in the abdomen (ascites), or liver-related brain problems
- People with other chronic liver diseases such as autoimmune liver disease, primary biliary cirrhosis, Wilson's disease, or iron overload conditions
- People with non-alcoholic fatty liver disease diagnosed by any imaging scan, or who have taken certain medications linked to fatty liver disease for more than 2 weeks in the year before screening
- People with a history of significant alcohol consumption (above defined daily amounts) for more than 3 consecutive months in the year before screening
- People with a liver scarring score (FIB-4) above 3.25 based on blood tests
- People who have had certain serious heart or blood vessel events within 6 months before screening, including heart attack, unstable chest pain, major heart or artery procedures, uncontrolled high blood pressure, stroke, or a mini-stroke (TIA)
- People with a serious heart failure condition with significantly reduced heart pumping function
- People with certain abnormalities on a heart tracing (ECG) test at screening, including a prolonged heart rhythm measurement or a history of serious heart rhythm problems
- People with a history of cancer in the past 5 years, except for certain treated skin cancers (basal cell or squamous cell carcinoma)
- People with other serious health conditions or abnormal test results that the study doctor believes could affect safety or the study results
- People who take high-dose daily oral steroids or other immune-suppressing medications
- People who have received immune-modifying antibody treatments (a type of medication that affects the immune system) within 6 months before screening
- People who use anti-inflammatory medications (NSAIDs) every day (note: limited daily use of paracetamol and low-dose aspirin is permitted — confirm details with trial site)
- People who have recently started (within 28 days before screening) certain medications known to affect the liver, including some cholesterol medications, certain antibiotics, or certain breathing or epilepsy medications — people already established on these medications for longer than 28 days before screening may not be excluded (confirm with trial site)
- People who take certain blood-thinning or anti-seizure medications that interact with a specific liver enzyme pathway (confirm with trial site)
- People who have taken part in another clinical trial using a non-biologic treatment or medical device within 4 weeks (or 5 half-lives of the drug, whichever is longer) before the first dose
- People who have taken part in a clinical trial using a biologic treatment within 6 months of screening
- People who have ever previously taken part in a gene therapy trial for Alpha-1 Antitrypsin Deficiency
- People with a known allergic reaction to the study drug (alvelestat/MPH966) or related medications
- People with a known allergy to medications used during study procedures such as bronchoscopy (a procedure to look inside the airways), including midazolam, fentanyl, or lidocaine
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Within-individual % Change in Plasma Desmosine/Isodesmosine; Numbers and % of Subjects Who Experience at Least 1 Treatment-emergent Adverse Event
Other options
Data last synced from ClinicalTrials.gov: 18 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.