What the trial was testing
The PRAISE enrolled 160 patients with pulmonary fibrosis. The study was sponsored by Kyntra Bio and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was mid-stage testing (phase 2/3). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
People getting pamrevlumab lost 60% less lung function over a year compared to those on placebo.
The Lancet. Respiratory medicine · 2020 · NCT01890265
These findings — that lung function declined much more slowly in those who got the treatment — were published in the The Lancet. Respiratory medicine and represent the headline result of the study.
Researchers tracked outcomes across 160 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with pulmonary fibrosis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was a mid-stage study and pamrevlumab is not yet FDA-approved. The drug is now being tested in larger trials. If you have idiopathic pulmonary fibrosis, ask your doctor whether you might qualify for a clinical trial or what approved treatments could help slow lung scarring.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open pulmonary fibrosis trials
A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants
The purposes of this study are to: 1. evaluate potential interactions between taladegib (ENV-101) and current standard-of-care (SOC) therapies for idiopathic pulmonary fibrosis (IPF), including nintedanib and pirfenidone, and 2. more fully characterize the pharmacokinetics (PK) of taladegib (i.e., how the body absorbs, distributes, metabolizes and excretes taladegib). This study will enroll 4 cohorts (groups) of participants. Each cohort will experience a different duration of treatment and sequestering (being housed) at the clinical site, followed by a 14-day follow-up period for safety evaluation. The longest duration of treatment for any cohort is 30 days.
Development of FAPI PET as a Non-invasive Biomarker of Pulmonary Fibrogenesis
The goal of this clinical trial is to gain more information about how fibroblast activation protein inhibitor (FAPI) binds to a certain type of cells in fibrotic lung tissue and how this information can be used to better diagnose and track fibrotic lung disease activity. Participants will undergo up to 4 PET/MRI scans using the FAPI radiotracer.