Waldo L L D Mattos, Nasreen Khalil, Lisa G Spencer, Francesco Bonella, Rodney J Folz, J Douglass Rolf, Nesrin Mogulkoc, Lisa H Lancaster, R Gisli Jenkins, David A Lynch, Paul W Noble, Toby M Maher, Vincent Cottin, Stefanie Senger, Gerald S Horan, Steven Greenberg, Zoran Popmihajlov
Rationale : Idiopathic pulmonary fibrosis is a fatal and progressive disease with limited treatment options. Objectives: To assess the efficacy and safety of CC-90001, an oral inhibitor of c-Jun N-terminal kinase 1, in patients with idiopathic pulmonary fibrosis. Methods: NCT03142191 was a phase 2, randomized (1:1:1), double-blind, placebo-controlled study in which patients received CC-90001 (200 or 400 mg) or placebo once daily for 24 weeks. Background antifibrotic treatment (pirfenidone) was allowed. The primary endpoint was change in percentage of predicted forced vital capacity (ppFVC) from baseline to Week 24; secondary endpoints included safety...
March 14, 2024: American Journal of Respiratory and Critical Care Medicine