Baseline characteristics of patients enrolled in FIBRONEER(TM)-IPF, a Phase III randomised placebo-controlled trial of the preferential PDE4B inhibitor BI 1015550 in patients with idiopathic pulmonary fibrosis
Bibliographic record
Abstract
Rationale Current antifibrotic (AF) treatments for idiopathic pulmonary fibrosis (nintedanib and pirfenidone) slow, but do not stop decline in pulmonary function. BI 1015550 is an oral preferential phosphodiesterase 4B (PDE4B) inhibitor that is under investigation for treatment of IPF. In a randomized Phase II study, BI 1015550 prevented any decline in lung function over 12 weeks in IPF patients independent of background AF use. A Phase III study, FIBRONEER-IPF (NCT05321069), is currently investigating efficacy and safety of BI 1015550 in patients with IPF, with a sister trial (FIBRONEER-ILD) underway in other progressive pulmonary fibrosis (PPF). Recruitment to FIBRONEER-IPF has completed. Here, we report the baseline demographics and disease characteristics of patients enrolled in this trial. Methods FIBRONEER-IPF is a randomized, double-blind, placebo-controlled, multicenter study in 45 countries worldwide. Patients aged≥40 years diagnosed with IPF, forced vital capacity (FVC)≥45% predicted and diffusing capacity of the lung for carbon monoxide (DL CO )≥25% predicted were randomised 1:1:1 to receive 9 mg or 18 mg of BI 1015550 or placebo twice daily over at least 52 weeks, stratified by background AF use. Prednisone or equivalent up to 15 mg/day is permitted. The primary endpoint is absolute change from baseline in FVC at Week 52. Fig. 1 Results A total of 1720 patients were screened, 1176 were randomized and 1160 started treatment. Median age:71 years (42–90 years),83% were male. Most patients were White or Asian, with a higher proportion of White patients in the AF group. Median FVC at baseline was 77% and DL CO was 48% predicted. A total of 191 patients (17%) were on oxygen therapy. A total of 815 patients (70%) were receiving background AF at baseline (480 [41%] nintedanib, 335 [29%] pirfenidone), with 345 (30%) receiving no background AF. Patients receiving background AF had a longer median time from diagnosis to study entry and were more likely to receive oxygen. Baseline characteristics by background AF use are shown in the Table. Conclusions BI 1015550 is the first preferential PDE4B inhibitor in Phase III trials in IPF and PPF. Characteristics of patients enrolled in the FIBRONEER-IPF trial are representative of the IPF population and consistent with other Phase III trials. Publication History Article published online: 18 March 2025 © 2025. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".