BI 1015550于2022年2月被美国食品药品监督管理局(FDA)授予突破性治疗认定。勃林格殷格翰未来将启动一项III期临床试验计划,以进一步研究BI 1015550改善IPF和其他类型PPF患者肺功能的疗效,并希望能尽快让该药物惠及患者。 关于试验 · II期随机、双盲、安慰剂对照试验(NCT04419506)主要研究IPF患者口服BI 1015550(18 mg,...
Methods and analysis In this phase III, double-blind, placebo-controlled trial, patients are being randomised 1:1:1 to receive BI 1015550 (9 mg or 18mg) or placebo twice daily over at least 52 weeks, stratified by background nintedanib use. Patients must be diagnosed with pulmonary fibrosis...
They added that a phase 3 trial would be necessary in evaluating these preliminary findings. “The safety profile of BI 1015550, in combination with the observed effects on the FVC, warrants further research as a treatment for IPF and other forms of progressive pulmonary fibrosis,” the investiga...
Design of Phase III, Randomized, Placebo-Controlled Trials of BI 1015550 in Patients with Progressive Fibrosing Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis (FIBRONEER-ILD / -IPF)doi:10.1055/s-0043-1761096Kreuter, MMaher, TAzuma, A...
Methods and analysis In this placebo-controlled, double-blind, phase III trial, patients are being randomised in a 1:1:1 ratio to receive 9 mg or 18 mg of BI 1015550 or placebo two times per day over at least 52 weeks, stratified by use of background antifibrotics (nintedanib/...