RT Journal Article
SR Electronic
T1 Idiopathic pulmonary fibrosis (IPF): observations from a Phase 2 trial of GLPG1205 (PINTA)
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 784
DO 10.1183/13993003.congress-2020.784
VO 56
IS suppl 64
A1 Strambu, Irina Ruxandra
A1 Fagard, Liesbeth
A1 Ford, Paul
A1 Van Der Aa, Tom
A1 De Haas-Amatsaleh, Angela
A1 Santermans, Eva
A1 Seemayer, Christian
YR 2020
UL http://erj.ersjournals.com/content/56/suppl_64/784.abstract
AB Introduction: Differential diagnosis of IPF is complex and may impact trial recruitment. In the EMPIRE registry (n=3,315; 11 largely Central/Eastern European countries) ~70% of IPF patients had definite usual interstitial pneumonia (UIP).1 PINTA (NCT03725852) is an ongoing randomized Phase 2 trial of GLPG1205 (GPR84 antagonist) on top of standard of care (nintedanib/pirfenidone/neither) in 69 IPF patients recruited in Central/Eastern Europe and Oman.Aim: To evaluate regional differences in recruitment and screen failures in PINTA.Methods: In PINTA, eligible patients (≥40 years old) had an IPF diagnosis within 5 years of screening, confirmed by central review of chest high-resolution computed tomography images and lung biopsy, if available.Results: Of 165 patients screened, 69 (42%) were randomized. Overall screen failure rate was 58%, varying between countries (Fig). Non-confirmation of UIP pattern by central reading accounted for approximately 2/3 of screen failures.Conclusions: PINTA suggests IPF trial recruitment is feasible in Central/Eastern Europe and Oman; non-confirmation of IPF diagnosis by central reading is an important finding.Reference: 1. Summary report, 17 Dec 2019. http://empire.registry.czAcknowledgments: PINTA is sponsored by Galapagos NV (Mechelen, Belgium). Writing support from Hannah Mace, CMPP (Aspire Scientific Ltd, Bollington, UK); funded by Galapagos NV.FootnotesCite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 784.This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).