NCT06102083

A Clinical Trial on the Treatment of Idiopathic Pulmonary Fibrosis

A Phase II, Multi-center, Randomized, Double-blinded, Placebo-controlled Clinical Study Evaluating the Efficacy and Safety of TDI01 Suspension for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Beijing Tide Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This trial was performed in patients with idiopathic pulmonary fibrosis (IPF) to evaluate the clinical efficacy and safety of different doses of TDI01 Suspension, compared with control, for the treatment of patients with IPF.

Detailed description

This is a Phase II, multi-center, randomized, double-blinded, placebo-controlled clinical study to evaluate the efficacy and safety of TDI01 Suspension for the treatment of IPF. The study consists of a 4-week screening period, a 24-week treatment period, a 28-week extension period, and a 2-week safety follow-up period. It is planned to include 120 IPF patients. All subjects will be randomized in a 1:1:1 ratio to receive a 24-week treatment with TDI01 Suspension dosage A, TDI01 Suspension dosage B, or the placebo. At Week 24, the subjects will be evaluated for the primary efficacy endpoints and subsequently enter the extension period. Subjects may continue receiving the investigational product until Week 52 at their voluntary consent.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	TDI01 suspension	Experimental group 1: Drug: TDI01 suspension Administration: TDI01 suspension once daily. Experimental group 2: Drug: TDI01 suspension Administration: TDI01 suspension once daily. Control group: Drug: Placebo Administration: Placebo once daily.

Timeline

• Start date: 2023-11-02
• Primary completion: 2025-08-01
• Completion: 2026-03-01
• First posted: 2023-10-26
• Last updated: 2023-11-02

Regulatory

• FDA-regulated drug study