Phase 2 Interstitial Lung Disease Trial, Completed NCT01890265 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 looked at a drug called pamrevlumab compared to a placebo (an inactive dummy treatment) in people with a lung-scarring condition called idiopathic pulmonary fibrosis (IPF). In total, 103 people took part in the main comparison (50 receiving pamrevlumab and 53 receiving placebo), with additional smaller groups testing the drug alongside two other medicines, pirfenidone and nintedanib, bringing the overall number enrolled to 160. The main thing the trial was measuring was a breathing test called FVC (forced vital capacity) — essentially how much air a person can breathe out — tracking any change over 48 weeks. The reported data shows that at the start of the trial, both groups had similar FVC readings (around 74–75% of what would be expected for a person of their age, sex, and size). After 48 weeks, the pamrevlumab group's average FVC had fallen by about 2.7 percentage points, while the placebo group's had fallen by about 7.2 percentage points. For the lung scarring measured by chest scans, the reported data shows scarring increased by an average of 2.7% in the pamrevlumab group and 6.0% in the placebo group by week 48. Regarding disease progression events (defined as death or a significant drop in breathing capacity), 5 out of 50 participants in the pamrevlumab group and 16 out of 51 in the placebo group recorded such an event. For respiratory-related hospitalisations, 5 pamrevlumab participants and 7 placebo participants were reported; for respiratory-related deaths, 2 were reported in the pamrevlumab group and 3 in the placebo group. On a quality-of-life questionnaire (where higher scores mean worse health), the reported data shows that starting scores were similar between groups, and changes over 48 weeks were also broadly similar, with neither group showing large shifts in either direction. It is worth noting that these numbers describe what was measured and recorded in this particular group of trial participants only. 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, Completed

NCT01890265
Completed 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 between 40 and 80 years old (inclusive).
  • You have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) confirmed by a specific type of chest scan (HRCT) or, in some cases, by a lung biopsy taken within the last 4 years.
  • Your IPF was first diagnosed 5 years ago or less.
  • Your chest scan shows a certain level of scarring in the lungs — at least 10% but less than 50% — and less than 25% of a specific pattern called "honeycombing" (confirm with trial site).
  • Your lungs are working at 55% or more of the expected level for someone your age and size, based on a breathing test.
  • If you are a woman who could become pregnant, you must be willing to use an approved form of birth control during the trial.
  • If you are a man whose partner could become pregnant and is not using birth control, you must be willing to use a barrier method (such as a condom) unless you have had a vasectomy.
  • For a specific part of the trial only: You have been taking pirfenidone or nintedanib at a stable dose for at least 3 months before the trial screening and are willing to continue taking it as prescribed.

Who may not be able to join:

  • You are currently pregnant or breastfeeding.
  • You have a lung condition other than IPF, such as another type of lung scarring disease, a lung disease caused by environmental exposure or medications, or a lung condition related to another illness affecting the whole body.
  • Your chest scan results do not match the specific pattern associated with IPF, as reviewed by the trial's specialist reader.
  • A lung biopsy shows a pattern other than the one associated with IPF.
  • Your doctor believes your IPF has clearly and consistently improved over the 12 months before the screening.
  • You have significantly abnormal results on blood or other laboratory tests.
  • You have had a respiratory infection (such as a cold or chest infection) in the 4 weeks before your first screening visit.
  • You had a sudden worsening of your IPF in the 3 months before your first screening visit.
  • You have recently taken certain medications used to treat IPF (the required time gap depends on the specific medication — confirm with trial site).
  • You have taken any experimental drugs within 4 weeks before the trial start date.
  • You have been diagnosed with cancer in the last 3 years, with some exceptions such as certain skin cancers or very early-stage cancers (confirm with trial site).
  • Your lungs' ability to transfer oxygen into the blood is less than 30% of what would normally be expected.
  • You have had a serious allergic reaction to certain types of antibody-based treatments in the past.
  • You have previously been treated with the drug FG-3019.
  • You weigh more than 130 kilograms (about 287 pounds).

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 19 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: Mark Wencel, M.D, Via Christi Clinic, P.A., USA

Australian sites

Concord Repatriation, Concord, New South Wales
Daw Park Repatriation, Adelaide, South Australia

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
Completed
Phase
Phase 2
Sponsor
Kyntra Bio
Registry
ClinicalTrials.gov
Start date
30 July 2013
Est. completion
16 November 2017

Where this trial is recruiting

🇦🇺 Australia 🇧🇬 Bulgaria 🇨🇦 Canada 🇮🇳 India 🇳🇿 New Zealand 🇿🇦 South Africa 🇺🇸 United States

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

Primary endpoints

Change From Baseline in FVC (Percent of Predicted FVC Value [% Predicted]) to 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: 19 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