Phase 2 Interstitial Lung Disease Trial, Terminated NCT05497284 Sponsor: Novartis Pharmaceuticals Condition: Interstitial Lung Disease
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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 (NCT05497284) enrolled 46 people in total — 23 received a treatment called LTP001 (at a 6mg dose) and 23 received a placebo (a dummy treatment with no active ingredient). The trial was looking at changes in lung function over a treatment period, primarily by measuring something called Forced Vital Capacity (FVC) — which is simply the total amount of air a person can breathe out in one go — expressed as a percentage compared to what would be expected for someone of a similar age, sex, and body size. By the end of the study, 15 people in the LTP001 group and 17 in the placebo group had completed the trial. The reported data shows that, on the primary measure, lung function (FVC as a percentage of predicted) declined in both groups by the end of the treatment period — by an average of 3.1 percentage points in the LTP001 group and 1.1 percentage points in the placebo group. For the secondary measures, the reported data shows the actual volume of air exhaled (FVC in millilitres) also fell in both groups — by an average of 120 mL in the LTP001 group and 45.5 mL in the placebo group. A separate secondary measure looked at how long participants went before experiencing a significant decline in lung function, hospitalisation, lung transplant, or death — the reported median time to such an event was 185 days in both groups. Six participants in the LTP001 group and five in the placebo group experienced a drop of 10% or more in their predicted FVC. The reported data also shows a separate measure of how well the lungs transfer gas into the bloodstream (DLCO) declined slightly less in the LTP001 group (−0.167 units) than in the placebo group (−0.334 units). Finally, on a six-minute walking distance test, the LTP001 group reported an average increase of 9.2 metres and the placebo group an average increase of 4.7 metres from the start of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

NCT05497284
Terminated Phase 2 🇦🇺 Australian site

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 at least 40 years old (male or female)
  • You have been diagnosed with a lung condition called IPF (idiopathic pulmonary fibrosis) based on specific medical guidelines
  • Your lungs are working at 45% or more of the expected capacity for someone your age and size (based on a breathing test called FVC)
  • A measure of how well your lungs transfer oxygen into your blood (called DLCO) is at 25% or above of what is expected
  • Your doctor does not expect you to need a lung transplant during the course of this trial
  • If you are already taking nintedanib or pirfenidone, you have been on a steady, unchanged dose for at least 8 weeks before joining the trial

Who may not be able to join:

  • You have a blockage or obstruction in your airways, or your airways showed a significant response to an inhaler during screening tests
  • A scan of your lungs showed that more than 20% of your lungs are affected by a condition called emphysema (air sac damage)
  • A scan of your lungs showed that less than 10% of your lungs show signs of scarring (fibrosis)
  • You have been diagnosed with a connective tissue disease (a condition affecting joints, skin, or organs, such as lupus or rheumatoid arthritis)
  • You have had a sudden, serious worsening of your IPF or another significant health decline in the 3 months before joining the trial

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Australian sites

Novartis Investigative Site, Camperdown, New South Wales
Novartis Investigative Site, Chermside, Queensland
Novartis Investigative Site, Spearwood, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Terminated
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
10 November 2022
Est. completion
26 August 2024

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇨🇿 Czechia 🇩🇪 Germany 🇳🇱 Netherlands 🇵🇱 Poland 🇺🇸 United States

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change From Baseline to End of Treatment Epoch in Forced Vital Capacity (FVC) Expressed in Percent Predicted

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov