Adaptive Phase 3 Trial of TDI01 Suspension Versus Placebo for Treating Idiopathic Pulmonary Fibrosis in Adults Aged 40 to 80

What this Trial Is About

Researchers are evaluating the efficacy and safety of TDI01 suspension for treating idiopathic pulmonary fibrosis IPF in a multicenter, randomized, double-blind, placebo-controlled, adaptive design clinical trial conducted in China. The trial includes two stages aiming to compare TDI01 with placebo in IPF patients, focusing on confirming treatment effects and safety. The study is planned for adults aged 40 to 80 years with confirmed IPF diagnosis. The study treatment involves TDI01 suspension given orally once daily at a dose of 400 mg on an empty stomach after shaking well. Both stages include a screening period, a main treatment period, an extension treatment period, and a safety visit period. Stage 1 plans to enroll 80 subjects, and Stage 2 plans to enroll 428 subjects with at least 40% receiving standard IPF therapies. The main treatment period in Stage 2 lasts 52 weeks, with the dosing and dose adjustment similar to Stage 1. Participants will undergo screening to confirm eligibility based on IPF diagnosis and lung function tests. Throughout the study, they will attend visits for assessments including lung function, safety monitoring, and outcome measurements at weeks 24 and 52. Researchers will monitor lung function parameters and other secondary outcomes, along with safety endpoints. The total participation duration includes screening, treatment, extension, and safety visits, with careful adherence to protocol requirements.

A Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)