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



  • Contact name

    Richard Marshall

  • Contact email

  • Sponsor organisation

    Galecto Biotech AB

  • Eudract number


  • ISRCTN Number


  • Identifier


  • 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


  • Date of REC Opinion

    24 Sep 2019

  • REC opinion

    Further Information Favourable Opinion

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