NCT03832946

A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

A Randomized, 52 Week, Double-blind, Multicentre, Parallel, Placebo-controlled Phase 2b Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Investigating the Efficacy and Safety of GB0139, an Inhaled Galectin-3 Inhibitor.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Galecto Biotech AB · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled phase 2b trial in subjects with IPF (idiopathic pulmonary fibrosis) investigating the efficacy and safety of GB0139.

Detailed description

This study is designed to evaluate the efficacy and safety of GB0139, a galectin-3 inhibitor, administered by dry powder inhalation over 52 weeks. GB0139, given once per day, will be compared to placebo. GB0139 was previously known as TD139.

Conditions

• Idiopathic Pulmonary Fibrosis (IPF)

Interventions

Type	Name	Description
DRUG	GB0139	GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.
DRUG	Placebo	Placebo is administered as inhalation once a day

Timeline

• Start date: 2019-02-19
• Primary completion: 2023-05-17
• Completion: 2023-05-17
• First posted: 2019-02-06
• Last updated: 2024-05-22
• Results posted: 2024-05-22

Locations

128 sites across 15 countries: United States, Australia, Belgium, Canada, France, Georgia, Germany, Ireland, Israel, Italy, Poland, Russia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study