1. Idiopathic pulmonary fibrosis (IPF): observations from a Phase 2 trial of GLPG1205 (PINTA)
- Author
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Christian A. Seemayer, Liesbeth Fagard, Angela De Haas-Amatsaleh, Eva Santermans, Tom Van Der Aa, Irina Strambu, and Paul Ford
- Subjects
medicine.medical_specialty ,business.industry ,Pirfenidone ,Lung biopsy ,respiratory system ,medicine.disease ,respiratory tract diseases ,Eastern european ,chemistry.chemical_compound ,Idiopathic pulmonary fibrosis ,chemistry ,Usual interstitial pneumonia ,Internal medicine ,medicine ,Nintedanib ,business ,Mace ,Pinta ,medicine.drug - Abstract
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.cz Acknowledgments: PINTA is sponsored by Galapagos NV (Mechelen, Belgium). Writing support from Hannah Mace, CMPP (Aspire Scientific Ltd, Bollington, UK); funded by Galapagos NV.
- Published
- 2020