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

  RMarshall@galecto.com

• Sponsor organisation

  Galecto Biotech AB

• Eudract number

  2018-002664-73

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT03832946

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  2 years, 1 months, 0 days

• Research summary

  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.

  Lay Summary of results:
  Purpose of the study:
  This study was set up to investigate a new drug called GB0139, to see if it can help people with a lung condition called idiopathic pulmonary fibrosis (IPF), which makes it hard for them to breathe. The drug is a powder that participants breathed in through a special device.

  The researchers split the participants into two groups. One group received the real drug (GB0139) and the other group received a dummy drug that does not do anything (which is called a placebo). Both the participants and the doctors did not know who received the real drug or the dummy drug – this is why the study was called ‘double-blind’. The study was conducted this way to make sure the results were fair, and because sometimes patients can feel better by simply knowing that they have received a drug.
  The participants were checked for one year to see if the participants taking the real drug had a reduced progression of their lung condition and did not have any side effects.

  People taking part in the study:
  This summary focuses on a total of 172 participants treated with the new drug (GB0139) at a dose of 3 mg or the dummy drug (placebo).

  Male and female participants, who were at least 40 years old and had been diagnosed with a lung disease called IPF in the past 5 years using specific medical criteria took part in the study.
  Participants were assessed to see how much air they could forcefully exhale after taking a deep breath (forced vital capacity or FVC), and were required to have more than 45% of what is expected.

  Results:
  The new drug (GB0139) did not affect the main assessment that doctors use to see how fast a patient’s lungs worsen over time (the decline in ‘forced vital capacity’ or FVC). Participants treated with GB0139 did not show any improvement compared to the participants treated with placebo (the dummy medicine). The study showed doctors that the new drug (GB0139) does not slow down the worsening of lung function in people with IPF. For these reasons, GB0139 will not be investigated further as a treatment for people with IPF

• 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