GALACTIC-1 Phase 2b study in idiopathic pulmonary fibrosis (IPF)
Research type
Research Study
Full title
GALACTIC-1 - A randomized, double-blind, multicentre, parallel, placebo controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks
IRAS ID
257627
Contact name
Richard Marshall
Contact email
Sponsor organisation
Galecto Biotech AB
Eudract number
2018-002664-73
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 1 months, 0 days
Research summary
This is a multicentre, randomised, double-blind, placebo-controlled phase 2b trial in participants diagnosed with idiopathic pulmonary fibrosis (IPF). The study is designed to evaluate the efficacy and safety of TD139, a Galectin-3 blocker, administered by dry powder inhalation over 52 weeks of dosing in addition to the participant’s current standard of care (SoC). Participants will be in the study for up to 116 weeks. The study is divided into 3 time periods: a screening period, a treatment period, and a follow-up period. If participants are eligible based on the screening period the will be randomly assigned to receive TD139 10 mg once a day by inhalation in addition to SoC, TD139 3 mg once a day by inhalation in addition to SoC, Placebo, which contains no active ingredient once a day by inhalation, in addition to SoC. They will have an equal chance to be assigned to either treatment group; neither they nor the trial doctor will know which treatment they receive. Participants will visit the study site which will be in a hospital setting up to 10 times during the study including the screening and follow up visits.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/0553
Date of REC Opinion
24 Sep 2019
REC opinion
Further Information Favourable Opinion