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 (NCT05321082) enrolled 1,178 people across three groups: 393 received a placebo (dummy treatment), 393 received a lower dose of nerandomilast (9 mg), and 392 received a higher dose (18 mg). The trial ran for up to 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. This test is commonly used to track lung function in people with fibrosing interstitial lung disease (scarring of the lung tissue). Several secondary outcomes were also tracked, including hospitalisations for breathing problems, sudden worsening of lung disease, and deaths. The reported data shows that for the primary measure — change in FVC in millilitres (mL) at 52 weeks — all three groups showed a decline from their starting point. The placebo group's lung capacity declined by an average of about 166 mL, while the 9 mg nerandomilast group declined by about 85 mL, and the 18 mg group declined by about 99 mL. Similarly, when lung capacity was measured as a percentage of what would be expected for a healthy person, the placebo group declined by about 4.9 percentage points, compared to about 2.7 points in the 9 mg group and about 2.9 points in the 18 mg group. The reported data for secondary outcomes shows that 64 people in the placebo group died during the trial, compared with 36 in the 9 mg group and 34 in the 18 mg group. For hospitalisations due to breathing problems or death combined, 113 placebo participants experienced at least one of these events, versus 90 in the 9 mg group and 94 in the 18 mg group. For the broader combined measure of serious lung worsening, hospitalisation for breathing reasons, or death, 82 placebo participants, 70 in the 9 mg group, and 74 in the 18 mg group experienced at least one such event. 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 41345848) ↗
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 3 Interstitial Lung Disease Trial, Completed
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:
- You are 18 years of age or older at the time of signing consent
- You have been diagnosed by a doctor with a progressive fibrosing interstitial lung disease (a scarring lung condition that keeps getting worse), but NOT the type called IPF
- You are either currently taking a stable, unchanged dose of nintedanib (a lung medication) for at least 12 weeks and plan to continue it, OR you have not taken nintedanib for at least 8 weeks and do not plan to start or restart it
- Your lung function tests show your lungs are working at 45% or more of the expected normal level (FVC test)
- Your lung function tests show your lungs' gas exchange is at 25% or more of the expected normal level, adjusted for your blood count (DLCO test)
- If you are a woman who could become pregnant, you are willing and able to use highly effective contraception (and an additional barrier method if using the pill)
- If you are taking certain immune-suppressing medications (such as Methotrexate or Azathioprine) for an underlying condition, your dose has been stable and unchanged for at least 12 weeks
Who may not be able to join:
- Your breathing test results show a certain airflow pattern suggesting a separate lung or airway problem (FEV1/FVC ratio below 0.7) (confirm with trial site)
- You have other significant lung problems beyond the condition being studied, in the opinion of the doctor running the trial
- You have had a sudden, severe flare-up of your interstitial lung disease within the past 3 months
- You currently have a significant ongoing or active infection, including HIV or hepatitis B or C
- Your interstitial lung disease developed as a result of a COVID-19 infection within the past 12 months
- You have had major surgery within the 6 weeks before the trial starts, or you are planning major surgery during the trial (being on a waiting list for a lung transplant does not count as planned surgery)
- You have been diagnosed with, or had, any cancer within the past 5 years — with the exception of certain treated skin cancers or cervical changes that have been appropriately treated
- Your blood test results at your first visit show that your liver enzyme or bilirubin levels are above certain limits (confirm with trial site)
Please note: Additional exclusion criteria apply beyond those listed here — confirm all details with the trial site.
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
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
13 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Absolute Change From Baseline in Forced Vital Capacity (FVC) in Milliliters [mL] at Week 52
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.