Phase 3 Interstitial Lung Disease Trial, Terminated NCT03955146 Sponsor: Kyntra Bio 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 (NCT03955146) looked at a drug called pamrevlumab compared to a placebo (an inactive treatment) in people with idiopathic pulmonary fibrosis (IPF) — a condition where the lungs gradually scar and stiffen over time. The main thing the trial measured was how much lung capacity changed over 48 weeks, using a breathing test called FVC (Forced Vital Capacity), which measures how much air a person can forcefully breathe out. The trial included two groups: a main study group of 356 people (181 received pamrevlumab, 175 received placebo), and a smaller Japan-based group of 37 people (18 received pamrevlumab, 19 received placebo). After the initial 48-week period, 252 participants from the main group continued into a longer follow-up phase. The reported data shows that in the main study group, lung capacity (FVC) declined by an average of 0.26 litres in those taking pamrevlumab and 0.33 litres in those taking placebo over 48 weeks — both groups experienced a reduction, just of different sizes. In the Japan group, the reported decline was 0.04 litres for pamrevlumab and 0.18 litres for placebo. The reported data also shows that for the secondary measures — such as time until disease got significantly worse or a serious event like hospitalisation or death occurred — the pamrevlumab group had an estimated median of 54.3 weeks before disease progression, compared to 50.7 weeks for placebo. For the combined measure of serious events (acute worsening, hospitalisation, or death), the median time was estimated at 62.7 weeks for the pamrevlumab group, while a median was not able to be calculated for the placebo group based on the available data. Lung scarring (measured by a scan-based score called QLF volume) increased in both groups over 48 weeks, with the main study pamrevlumab group showing a rise of 251 mL compared to 268 mL in the placebo group. 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 3 Interstitial Lung Disease Trial, Terminated

NCT03955146
Terminated Phase 3 🇦🇺 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 have been diagnosed with a lung disease called IPF (idiopathic pulmonary fibrosis) in the last 7 years, following recognised medical guidelines.
  • A recent detailed lung CT scan shows a specific amount of scarring in your lungs — between 10% and 50% scarring (reticulation), with less than 25% of a particular pattern called honeycombing.
  • Your lung capacity (measured by a breathing test called FVC) is between 45% and 95% of what would be expected for someone of your age and size.
  • A test measuring how well your lungs transfer oxygen into your blood (called DLCO) falls within a specific range — at least 25% but no more than 90% of the expected value.
  • You are not currently taking either of the two approved IPF medications (pirfenidone or nintedanib), for any reason — whether due to side effects, the treatment not working, or a personal choice made after talking with your doctor.

Who may not be able to join:

  • You have previously received a treatment called pamrevlumab.
  • You have significant blockage or obstruction in your airways (a different type of lung problem).
  • You are currently pregnant or breastfeeding.
  • You have smoked within the past 3 months before the screening visit, or you are unwilling to avoid smoking during the study.
  • You have a different type of lung scarring condition other than IPF.
  • Your IPF symptoms have noticeably and consistently improved in the 12 months before screening.
  • You have a history of other respiratory or lung-related conditions affecting the airways, lung tissue, or surrounding structures such as the chest wall or diaphragm.
  • You have certain other serious health conditions — for example, a heart attack or stroke in the past 6 months — or other challenges that the trial doctor feels would prevent you from safely taking part (confirm with trial site).
  • You are currently experiencing a sudden and severe worsening (flare-up) of your IPF during the screening or enrolment period.
  • You have taken part in another clinical trial or used an experimental drug within the last 30 days, or have taken pirfenidone or nintedanib within 1 week before screening.
  • You have had a serious allergic reaction (including severe reactions called anaphylaxis) to certain types of antibody-based medicines or their ingredients (confirm with 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.

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 26 July 2026
Phase 3: approximately ~65% 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

Royal Prince Alfred Hospital, Sydney, New South Wales
Westmead Hospital, Westmead, New South Wales
Mater Health Services Adult Hospital, South Brisbane, Queensland
Royal Adelaide Hospital, Adelaide, South Australia
Box Hill Hospital, Box Hill, Victoria
The Alfred Hospital, Melbourne, Victoria

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

Status
Terminated
Phase
Phase 3
Sponsor
Kyntra Bio
Registry
ClinicalTrials.gov
Start date
18 June 2019
Est. completion
20 March 2023

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇨🇱 Chile 🇨🇳 China Hong Kong 🇷🇺 Russia 🇰🇷 South Korea 🇹🇼 Taiwan 🇺🇸 United States

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

Primary endpoints

DB Period (Main Study Cohort): Change From Baseline in FVC at Week 48; DB Period (Japan Extension Cohort): Change From Baseline in FVC at Week 48

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: 26 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