NCT07464912

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

A Multicentre, Randomised, Double-blind, Placebo-controlled, Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 508 (estimated)
• Sponsor: Beijing Tide Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicentre, randomised, double-blind, placebo-controlled, adaptive design clinical trial to evaluate the efficacy and safety of TDI01 suspension in the treatment of idiopathic pulmonary fibrosis (IPF). The study will be conducted in China and divided into two stages, both of which are multicentre, randomised, double-blind, placebo-controlled studies. Stage 1 aims to evaluate the efficacy and safety of TDI01 suspension compared to the placebo group in the treatment of IPF patients, and Stage 2 aims to further confirm the efficacy and safety of TDI01 suspension compared to the placebo group in the treatment of IPF patients.

Detailed description

\[Stage 1 study design\] Stage 1 is divided into a screening period, a main study treatment period, an extension treatment period, and a safety visit period. Based on a previous Phase 2 study, it is planned to enrol 80 subjects. All subjects who may participate in this study will enter the screening period (no more than 4 weeks) after voluntarily signing the informed consent form, and the investigator will assess the eligibility of the subjects according to the inclusion and exclusion criteria. All subjects will be re-assessed for eligibility before randomisation, and those who meet the criteria can enter the main study treatment period. \[Stage 2 study design\] Stage 2 is divided into a screening period, a main study treatment period, an extension treatment period, and a safety visit period. It is initially planned to enrol 428 subjects, and the target population for both stages is the same. The inclusion and exclusion criteria and randomisation procedure for the screening period of Stage 2 are the same as those for Stage 1. The main study treatment period is 52 weeks. The dosing regimen and dose adjustment plan for the investigational medicinal product in Stage 2 are the same as those in Stage 1. The proportion of subjects receiving IPF therapeutic drugs shall not be less than 40% of the total number of subjects.

Conditions

• Idiopathic Pulmonary Fibrosis (IPF)

Interventions

Type	Name	Description
DRUG	TDI01	TDI01 suspension

Timeline

• Start date: 2025-12-24
• Primary completion: 2029-07-30
• Completion: 2029-12-30
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study