Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis

Scarring of the lung, termed pulmonary fibrosis (PF), is a chronic, progressive, and usually fatal disorder. While two anti-fibrotic drugs have been approved for treating PF of unknown cause (idiopathic pulmonary fibrosis or IPF), neither drug is curative, and nearly 40% of patients stop taking the prescribed drug within a year because of side effects. The study includes the use of saracatinib, an investigational drug originally developed to treat certain types of cancers, in the treatment of IPF in a Phase 1b/2a clinical trial. The objectives of this study are to: i) evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, and to explore the efficacy of saracatinib in IPF; ii) identify biomarkers of Src kinase activity and fibrogenesis linked to pulmonary fibrosis; and iii) explore the application of these biomarkers to assess the anti-fibrotic effect of saracatinib in IPF patients

NCT Number	NCT04598919
Lead Sponsor	National Jewish Health Collaborators: Yale University, Icahn School of Medicine at Mount Sinai, AstraZeneca, National Center for Advancing Translational Sciences (NCATS), Baylor University, International Center for Health Outcomes and Innovation Research
Conditions	Idiopathic Pulmonary Fibrosis (IPF)
Enrollment	49 participants
Start Date	2020-11-12
Primary Completion	2024-09-15 (estimated)
Study Completion	2025-06-30 (estimated)
Updated on ClinicalTrials.gov	2024-11-14