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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03832946
Recruitment Status : Completed
First Posted : February 6, 2019
Results First Posted : May 22, 2024
Last Update Posted : May 22, 2024
Syneos Health
Information provided by (Responsible Party):
Galecto Biotech AB

Brief 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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis (IPF) Drug: GB0139 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

All subjects eligible for the study will be randomised into one of the two treatment arms:

A. GB0139 3 mg once a day B. Placebo once a day

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This study is a double-blind study. The blinding will be maintained throughout the study.
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : February 19, 2019
Actual Primary Completion Date : May 17, 2023
Actual Study Completion Date : May 17, 2023

Arm Intervention/treatment
Experimental: A. GB0139 3 mg once a day
Inhalation of GB0139
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.
Other Name: TD139

Placebo Comparator: B. Placebo once a day
Inhalation of Placebo
Drug: Placebo
Placebo is administered as inhalation once a day

Primary Outcome Measures :
  1. Annual Rate of Decline in Forced Vital Capacity (FVC) [ Time Frame: 52 weeks ]
    Efficacy of GB0139 as measured by the annual rate of decline in FVC expressed in mL

Secondary Outcome Measures :
  1. Number of Participants With Respiratory Related Hospitalizations [ Time Frame: 52 weeks ]
    Number of Participants with Respiratory Related Hospitalizations from randomisation (including acute exacerbation of IPF).

  2. Assessment of Respiratory Related Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 52 weeks ]
    Change from baseline to WK52 in the SGRQ total score. The SGRQ is a 50-item questionnaire split into three domains: symptoms, activity and impact. Weighting of both individual domains and the total score produces a range from 0 to 100, with higher scores indicating a poorer health-related quality of life.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male and female subjects aged ≥ 40 years of age with a diagnosis of IPF established during the previous five years according to ATS/ERS/Fleischner criteria.
  2. Lung function parameters as follows:

    1. Forced Vital Capacity (FVC) > 45% of the predicted value at screening
    2. Diffusion lung capacity for carbon monoxide (DLCO) (corrected for Hb) of 30% to 79% of the predicted value at screening
  3. Subjects who currently are not being treated with nintedanib or pirfenidone; or cannot tolerate nintedanib or pirfenidone
  4. Subjects must sign and date a written, IRB/EC approved informed consent form and any required authorization prior to initiation of any study procedures.

Exclusion Criteria:

  1. Currently has significant airways obstruction: Forced Expiratory Volume in 1 s (FEV1)/Forced Vital Capacity (FVC) ratio of < 0.7 at screening.
  2. Has clinical evidence of active infection, including, but not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis.
  3. Has a history of malignancy within the last 2 years with the exception of basal cell carcinoma, chronic lymphocytic leukaemia (under observation) and prostate cancer requiring anti-androgens, localised treatment (minor surgery, radiotherapy) and/or managed by observation.
  4. Has any condition other than IPF that, in the opinion of the investigator, is likely to result in the death of the subject within the next 2 years.
  5. Presence of other disease that may interfere with testing procedures or in the judgement of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial.
  6. Is likely to receive lung transplantation within the next 12 months.
  7. Currently receiving nintedanib, pirfenidone, high dose corticosteroid, cytotoxic (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), vasodilator therapy for pulmonary hypertension (e.g., bosentan). A current dose of less than or equal to 15 mg/day of prednisone or its equivalent is acceptable if the dose is anticipated to remain stable during the study.
  8. Prior use of GB0139 (also called TD139) or previously randomized in GALACTIC-1.
  9. Prior use of nintedanib or pirfenidone within 7 days of initiation of screening.
  10. Prior use of investigational drugs within 30 days (or 5 half-lives, whichever is longer) of initiation of screening.
  11. Participating in another clinical trial, either interventional or observational.
  12. Has a history of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous six months, including, but not limited to, the following:

    1. Unstable angina pectoris or myocardial infarction, or percutaneous coronary intervention within the last 6 months
    2. Congestive heart failure requiring hospitalization
    3. Uncontrolled clinically significant arrhythmias
  13. If female, the subject is pregnant or lactating or intending to become pregnant before participating in this study during the study and within (5 half- lives plus 30 days) after last dose of the study drug; or intending to donate ova during such time period.
  14. Woman considered to be of childbearing potential who do not use highly effective birth control methods during the study.
  15. Hypersensitivity to the active substance (TD139/GB0139) or the excipient (lactose).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03832946

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Sponsors and Collaborators
Galecto Biotech AB
Syneos Health
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Principal Investigator: Toby Maher, MD, PhD Keck Medicine of USC
  Study Documents (Full-Text)

Documents provided by Galecto Biotech AB:
Study Protocol  [PDF] January 28, 2022
Statistical Analysis Plan  [PDF] July 7, 2023

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Galecto Biotech AB Identifier: NCT03832946    
Other Study ID Numbers: GALACTIC-1
2018-002664-73 ( EudraCT Number )
First Posted: February 6, 2019    Key Record Dates
Results First Posted: May 22, 2024
Last Update Posted: May 22, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Galecto Biotech AB:
Idiopathic pulmonary fibrosis
Galectin-3 inhibitor
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases