Phase 2 Interstitial Lung Disease Trial, Terminated NCT01629667 Sponsor: MedImmune LLC 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 enrolled 176 people in total across three groups: one group received a placebo (an inactive treatment), one received a dose of 400 mg of a medicine called tralokinumab, and one received 800 mg of tralokinumab. The trial was studying people with idiopathic pulmonary fibrosis (IPF), a serious lung condition, and ran for up to 88 weeks. The main thing being measured was how much a standard breathing test result — called forced vital capacity, or FVC, which measures the amount of air a person can forcibly breathe out — changed over 52 weeks. It is worth noting that a relatively large number of participants did not complete the study: only 12 in the placebo group, 17 in the 400 mg group, and 14 in the 800 mg group finished. The reported data shows that at the start of the trial, average FVC results (expressed as a percentage of what would be expected for a healthy person of the same age, sex, and height) were around 70% across all three groups. By week 52, the reported change from that starting point was a decline of about 4.1 percentage points in the placebo group, 6.1 percentage points in the 400 mg tralokinumab group, and 6.1 percentage points in the 800 mg tralokinumab group. For the secondary outcomes, the reported data shows that unwanted medical events during the study (called adverse events) were recorded in 53 of 57 placebo participants, 50 of 57 in the 400 mg group, and 57 of 59 in the 800 mg group. Serious adverse events were recorded in 13, 16, and 17 participants respectively. Regarding disease progression — defined by meaningful declines in breathing tests, hospitalisation, or respiratory-related death — roughly 35% of the placebo group and 35% of the 400 mg group showed progression at one reported time point, compared with about 29% of the 800 mg group, though at a later time point those figures rose to around 42%, 42%, and 44% respectively. 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

NCT01629667
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 have been diagnosed with a lung condition called IPF (idiopathic pulmonary fibrosis) within the last 5 years or less before the screening visit.
  • Your IPF diagnosis has been confirmed using clinical assessment, a special type of lung scan (HRCT), and possibly a surgical lung biopsy if needed.
  • Your IPF is considered mild to moderate, meaning your lung function tests show your lungs are working at 50% or more of the expected normal level (FVC).
  • Your blood oxygen levels meet a minimum level — either measured by a blood test (PaO2 of at least 55 mmHg at normal altitude, or 50 mmHg at high altitude above 1,500 meters) or by a finger pulse monitor showing 90% or above while resting and breathing normal air.
  • A specific measure of how well your lungs transfer oxygen into your blood (called DLCO) is at 30% or more of the expected normal level.
  • You are able to walk at least 100 meters (roughly the length of a football field) on your own without help.

Who may not be able to join:

  • A specific breathing test ratio (FEV1/FVC, measured after using an inhaler) is below 0.70, which may suggest another lung condition is present.
  • Your lung scan (HRCT) shows that the damage from air sacs breaking down (emphysema) is more widespread than the scarring (fibrosis).
  • You are already on a waiting list for a lung transplant.
  • You have taken certain medicines that suppress the immune system (such as methotrexate, cyclosporine, azathioprine, or long-acting steroid injections) within the 3 months before screening — though a low daily dose of oral steroid (prednisone 15 mg or less per day) may be allowed if you have been on a stable dose for at least 30 days (confirm with trial site).
  • You have taken a drug called pirfenidone within the 4 weeks before screening.
  • You have taken a supplement called N-acetylcysteine within the 4 weeks before screening.
  • You have received a live vaccine (such as certain flu or travel vaccines) within the 4 weeks before screening.

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 23 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

Principal Investigator: Joseph Parker, MD, MedImmune LLC

Australian sites

Research Site, Box Hill,
Research Site, Camperdown,
Research Site, Concord,
Research Site, Darlinghurst,
Research Site, Frankston,
Research Site, Glen Osmond,
Research Site, New Lambton,
Research Site, Parkville,
Research Site, Prahran,
Research Site, Woodville South,

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 2
Sponsor
MedImmune LLC
Registry
ClinicalTrials.gov
Start date
1 October 2012
Est. completion
1 May 2015

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇮🇱 Israel 🇵🇪 Peru 🇰🇷 South Korea 🇺🇸 United States

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

Primary endpoints

Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52

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: 23 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