A Phase 2, randomized, double-blind, placebo-controlled, parallel group study (TRANSFORM) to evaluate the efficacy and safety of GSK3915393 in participants with Idiopathic Pulmonary Fibrosis (IPF) - 220929

Glaxosmithkline Research & Development Limited0 个研究点目标入组 150 人开始时间: 2024年2月14日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•IPF diagnosed within 5 years prior to screening based on the applicable ATS/ERS/JRS/ALAT Guideline at the time of diagnosis., FVC =45% of predicted normal., Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) =25% of predicted normal corrected for hemoglobin (Hb)., If receiving antifibrotics must be on stable dose of nintedanib or pirfenidone for at least 12 weeks prior to screening., If not receiving approved antifibrotics (pirfenidone or nintedanib) there should be a valid reason for this, such as previous failure, contraindications, failure to meet national or regional eligibility criteria for anti-fibrotic treatment, or patient choice.

•ILD associated with other known causes., Acute IPF exacerbation within 6 months prior to screening and/or during the screening period, Clinically significant respiratory tract infection (e.g., active tuberculosis, infectious pneumonia, COVID-19) requiring treatment within 4 weeks prior to and/or during the screening period., Current or chronic liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones)., History of previous lung transplant or recent major surgery within 12 weeks prior to screening or planned during the trial period.

发起方