ArticleBMC pulmonary medicine2025
Design of an open-label extension trial of nerandomilast (BI 1015550) in patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis (FIBRONEER™-ON).
Article in BMC pulmonary medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)
Who cites it
2 citing papers in PubMed.
- Cellular Senescence: Emerging Therapeutic Target for Idiopathic Pulmonary Fibrosis Pathogenic Mechanisms and Therapeutic Strategies.Biomolecules & therapeutics · 2026Review
- Hydrogel-Embedded Precision-Cut Lung Slices Recapitulate Fibrotic Gene Expression and Enable Therapeutic Response Evaluation.bioRxiv : the preprint server for biology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is a need for more effective treatments for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Nerandomilast (BI 1015550), an oral preferential inhibitor of phosphodiesterase 4B, is being evaluated in two randomized Phase III trials: FIBRONEER™-IPF (NCT05321069) and FIBRONEER™-ILD (NCT05321082). FIBRONEER™-ON is an open-label extension (OLE) of these studies that will evaluate the long-term safety and efficacy of nerandomilast. Here, we describe the study design of the OLE.
methodsThis prospective 98-week OLE will follow the Phase III parent trials, which are currently underway with 1177 patients enrolled in FIBRONEER™-IPF and 1178 patients enrolled in FIBRONEER™-ILD. Approximately 1700 patients from 44 countries are expected to complete the parent trials and will be eligible for continuing into the OLE; this estimate assumes that there will be a discontinuation rate of ~25% over the duration of the parent trials and > 90% of eligible patients will agree to participate in the OLE. Irrespective of whether previously on active treatment or placebo, all patients in the OLE will be treated with nerandomilast at either 9 mg or 18 mg twice daily, depending on which dose demonstrates the most favorable benefit-risk profile in the parent trials. The primary endpoint will be the occurrence of any adverse event over the course of the OLE. This trial will also monitor long-term efficacy outcomes, including forced vital capacity change, and time to first exacerbation, disease progression, hospitalization and death. DISCUSSION: This trial will provide information on the long-term safety, tolerability and efficacy of nerandomilast in patients with IPF and PPF.
trial registrationFIBRONEER™-ON: ClinicalTrials.gov: NCT06238622, registered 2 February 2024. Protocol version and date: version 3.0, 29 Apr 2024. FIBRONEER™-IPF: ClinicalTrials.gov: NCT05321069, registered 11 March 2022.FIBRONEER™-ILD: ClinicalTrials.gov: NCT05321082, registered 11 March 2022.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.