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 (NCT03573505) enrolled 106 adults with idiopathic pulmonary fibrosis (IPF) — a condition that causes scarring of the lungs. Fifty-two participants were assigned to receive a placebo (an inactive treatment) and 54 received the investigational drug BG00011. The trial ran for 52 weeks and was primarily measuring changes in lung capacity — specifically a breathing test called Forced Vital Capacity (FVC), which measures how much air a person can breathe out forcefully. It is worth noting that the reported data shows zero participants were recorded as having "completed" the study, which may reflect an early stopping of the trial; no further explanation of this was provided in the submitted data. The reported data shows that at the start of the trial, average FVC was 2.883 litres in the placebo group and 2.867 litres in the BG00011 group. By week 52, the placebo group's FVC had declined by an average of 0.308 litres, while the BG00011 group's FVC had declined by an average of 0.455 litres. When lung capacity was expressed as a percentage of what would be expected for a healthy person of similar age and size, the placebo group declined by 7.6 percentage points on average, compared with 11.5 percentage points in the BG00011 group. For a secondary measure looking at how quickly participants reached a significant worsening point (such as a large lung function drop, hospitalisation, transplant, or death), the reported median time was 127.5 days in the placebo group and 119.0 days in the BG00011 group. The reported data also shows that 0 participants in the placebo group experienced an acute flare-up (sudden worsening) of their IPF, compared with 7 participants in the BG00011 group, accounting for 8 recorded flare-up events in total. The time-to-first-flare-up figure for the placebo group was not reported in the submitted data. 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 ↗ · Read the linked publication on PubMed (PMID 35771569) ↗
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 Interstitial Lung Disease Trial, Terminated
Who may 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 might be able to join this trial:
- Women must be unable to become pregnant (either through surgery or menopause for at least 1 year), or must agree to use highly effective birth control from the time of signing the consent form until 3 months after the last study injection; men must also agree to use highly effective birth control for themselves or their partners until 4 months after the last injection.
- You must have been diagnosed with a lung scarring disease called IPF (idiopathic pulmonary fibrosis) within the last 3 years, based on recognised international guidelines.
- Your diagnosis must be supported by a specific type of lung scan (high-resolution CT), and if you have had a surgical lung biopsy, those results must also be consistent with IPF.
- A breathing test measuring how well your lungs transfer oxygen into the blood must show a result between 30% and 79% of what is considered normal, with no significant worsening before you are enrolled.
- A separate breathing test measuring how much air you can breathe out must show a result of at least 50% of what is considered normal, with no significant worsening before you are enrolled.
- If you are already taking nintedanib or pirfenidone (common IPF medicines), you must have been on a stable, unchanged dose for at least 8 weeks before joining the trial.
Who may not be able to join:
- People who are unable to complete breathing tests or have a high-resolution CT lung scan.
- People whose blood oxygen level at rest is below 90%, or who need more than 2 litres per minute of supplemental oxygen at rest.
- People whose breathing tests suggest a different type of lung condition involving blocked or reversible airways (confirm with trial site).
- People whose lung scarring is so advanced that they are likely to need an organ transplant within 12 months, or who have already started being evaluated for a transplant.
- People whose lung scans show that emphysema (a different type of lung damage) is more widespread than the scarring caused by IPF.
- People who weigh less than 60 kg (approximately 132 lbs) at the time of screening.
- People with a current or past history of cancer, with the exception of certain skin cancers or a specific type of cervical pre-cancer that was fully removed and considered cured more than 2 years ago.
- People with significant heart problems, such as severe heart failure, a heart attack in the last 6 months, unstable chest pain, recent heart procedures, uncontrolled abnormal heart rhythms, or high blood pressure in the lungs requiring medication.
- People who have been diagnosed with a connective tissue or autoimmune disease, such as scleroderma, lupus, rheumatoid arthritis, or similar conditions.
- People with another illness that could interfere with the study tests or put them at risk during participation, as judged by the study doctor.
- People who are considered unsuitable for the trial for any other reason, as determined by the study doctor or the study sponsor.
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.
Contact this trial
Principal Investigator: Medical Director, Biogen
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
10 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.