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

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ClinicalTrials.gov Identifier: NCT03832946
Recruitment Status : Completed
First Posted : February 6, 2019
Last Update Posted : May 25, 2023
Sponsor:
Collaborators:
Syneos Health
bioRASI, LLC
Information provided by (Responsible Party):
Galecto Biotech AB

Study Description
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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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 426 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: 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 GB0139, an Inhaled Galectin-3 Inhibitor Administered Via a Dry Powder Inhaler Over 52 Weeks
Actual Study Start Date : February 19, 2019
Actual Primary Completion Date : May 17, 2023
Actual Study Completion Date : May 17, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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. Absolute decline in FVC >10% [ Time Frame: 52 weeks ]
    Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of > 10%

  2. Time to first hospitalization [ Time Frame: 52 weeks ]
    Time to first hospitalization (respiratory related, including acute exacerbation of IPF) expressed in days.

  3. Time to death [ Time Frame: 52 weeks ]
    Time to death from all-causes, respiratory-related causes and/or caused by IPF expressed in days

  4. Assessment of Respiratory Related Quality of Life using the St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 52 weeks ]
    Change from baseline 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.


Other Outcome Measures:
  1. Absolute decline in FVC >5% [ Time Frame: 52 weeks ]
    Percentage of subjects with an absolute decline from baseline in FVC (% predicted) of > 5%

  2. 6-minute walk test (6MWT) distance [ Time Frame: 52 weeks ]
    Change from baseline in distance walked (metres) over 6 minutes

  3. Diffusion capacity of the lung for carbon monoxide (DLCO) [ Time Frame: 52 weeks ]
    Change from baseline in DLCO, corrected for Hemaglobin (mmol/min/kPa)

  4. Assessment of Dyspnea using the University of California San Diego - Shortness of Breath Questionnaire (UCSD - SOBQ) [ Time Frame: Weeks 12, 26 and 52 ]
    Change from baseline in UCSD - SOBQ Scored from 0-120 where a higher score indicates worse dyspnea

  5. Assessment of Health Related Quality of Life (HRQoL) using the Short-Form 36-Item Health Survey (SF-36) [ Time Frame: Weeks 12, 26 and 52 ]
    The Medical Outcomes SF-36 It is a self-administered questionnaire of 36-items measuring eight dimensions of general HRQoL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively. A higher score indicates a more favourable state of health

  6. Frequency of Adverse Events (AE) or Serious Adverse Events (SAE) [ Time Frame: 52 weeks ]
    Percentage of subjects with Adverse Events (AE) or Serious Adverse Events (SAE)

  7. Time to hospitalization [ Time Frame: 52 weeks ]
    Time in days to first hospitalization from all causes

  8. Time to hospitalization [ Time Frame: 52 weeks ]
    Time in days to first hospitalization (IPF related, including acute exacerbation of IPF)

  9. Time to respiratory related death [ Time Frame: 52 weeks ]
    Time in days to death from respiratory related causes (including IPF)

  10. Time to initiation of pirfenidone or nintedanib treatment [ Time Frame: 52 weeks ]
    Time in days to initiation of pirfenidone or nintedanib treatment in subjects not treated with pirfenidone or nintedanib at time of enrolment

  11. Annual rate of decline in FVC in subjects never treated with pirfenidone or nintedanib [ Time Frame: 52 weeks ]
    Change in FVC expressed in mL for subjects who have never been treated with pirfenidone or nintedanib


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

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).
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03832946


Locations
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Sponsors and Collaborators
Galecto Biotech AB
Syneos Health
bioRASI, LLC
Investigators
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Principal Investigator: Toby Maher, MD, PhD Keck Medicine of USC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Galecto Biotech AB
ClinicalTrials.gov Identifier: NCT03832946    
Other Study ID Numbers: GALACTIC-1
2018-002664-73 ( EudraCT Number )
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: May 25, 2023
Last Verified: May 2023

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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:
TD139
Idiopathic pulmonary fibrosis
Galectin-3 inhibitor
GB0139
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases