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

Primary Purpose

Idiopathic Pulmonary Fibrosis (IPF)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GB0139
Placebo
Sponsored by
Galecto Biotech AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis (IPF) focused on measuring TD139, Idiopathic pulmonary fibrosis, Galectin-3 inhibitor, GB0139

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • SEC Clinical Research
  • Jasper Summit Research, LLC Pulmonary & Sleep Associates
  • Palmtree Clinical Research Inc
  • Paradigm Research
  • Yale University School of Medicine
  • Health Shands Hospital
  • Harmony Medical Research Institute, Inc
  • Advanced Research for Health Improvement
  • Broward Research Centre
  • Avanza Medical Research Centre
  • Coastal Pulmonary Critical Care PLC
  • Tampa General Hospital/Uni Florida
  • Piedmont Healthcare Pulmonary and Critical Care Research
  • The Emory Clinic
  • DC Research Works
  • Northwestern Memorial Hospital
  • LaPorte County Institute for Clinical Research
  • University of Kansas Medical Centre
  • University of Louisville Hospital
  • University of Maryland
  • Harvard Medical School - Brigham and Womens Hospital (BWH)
  • The Lung Research Center LLC
  • Dartmouth-Hitchcock Medical Center
  • Pulmonlx LLC
  • University of Cincinnati
  • The Cleveland Clinic Foundation
  • Thomas Jefferson University
  • Vanderbilt University Medical Center
  • University of Texas Health Centre at Houston
  • University of Texas Health Sciences Center at Houston
  • Diagnostics Research Group
  • University of Utah Health Scieces Center
  • TPMG Clinical Research
  • Medical College of Wisconsin
  • Lung Research QLD
  • Flinders Medical Centre
  • Respiratory Clinical Trials
  • Institute for Respiratory Health Sir Charles Gairdner Hospital
  • TrialsWest
  • Cliniques Universitaires St-Luc
  • UZ Antwerp
  • CUB Hopital Erasme
  • UZ Leuven- Campus Gasthuisberg
  • CHU UCL Namur site Godinne
  • Firestone Institute for Respiratory Health
  • Dr Anees Medicine Professional Corporation
  • Dr Dhar Medical Practice
  • Toronto General Hosp Research Inst
  • Groupe Hospitalier Hopitaux Universitaires Paris-Seine-Saint-Denis-Hopital Avicenne
  • CHRU Lille - Hopital Calmette
  • Hopital Nord de Marseille
  • APHP - Hopital Europen Georges-Pompidou
  • Hopital Bichat
  • Centre Hospitalier Universitaire de Rennes Hopital Pontchaillou
  • CHU de la Réunion Site SUD (Terre Sainte)
  • CHU de la Réunion- Site Félix Guyon
  • Hopitaux Universitaires de Strasborg Service de Pneumologie Nouvel Hopital Civil
  • Centre Hospitalier Rgional et Universitaire - Hopital Bretonneau
  • Chapidze Emergency Cardiology Center
  • The First Medical Center
  • Thoraxklinik-Heidelberg gGmbH
  • Lungenfachklinik Immenhausen Department for Clinical Studies
  • ZMS Zentrum für medizinische Studien GmbH
  • Klifeck GmbH Praxis Med. Gerald Eckhardt
  • Studienzentrum Dr.med Falk Brunner FA fuer Innere Medizin und Pneumologie
  • CIMS Studienzentrum Bamberg GmbH
  • Krankenhaus Donaustauf
  • Ruhrlandklinik Essen
  • Universitaetsklinikum Leipzig Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, P
  • POIS Leipzig GbR
  • Klinikum Grossadern der Ludwig-Maximilians-Universitaet Muenchen
  • Trinity Centre for Health Sciences
  • Hadassah Medical Center
  • Meir Medical Center
  • Pulmonary Institute Rabin Medical Center
  • Sheba Medical Center
  • Kaplan Medical Center
  • University-Hospital Policlinico Vittorio Emanuele
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Ospedale San Giuseppe Clinica Malattie dell Apparato Respiratorio
  • University Hospital of Mondena-AOU - Policlinico di Modena
  • A.O. Dei Colli OSPEDALE MONALDI
  • Ospedale GB Morgagni
  • Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
  • Azienda Ospedaliera Universitaria Senese
  • AOU Città della Salute e della Scienza, PO Molinette
  • Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc
  • Oddział Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie
  • Klinika Alergologii Pneumonologii
  • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
  • Hospital Universitario Central de Asturias
  • Hospital Univ. Marques de Valdecilla
  • Hospital Universitario Lucas Augusti
  • Hospital Universitario Quiron Madrid
  • Policlinica Barcelona
  • Hospital Clinic de Barcelona
  • Hospital de la Santa Creu i Sant Pau
  • Hopital de Bellvitge
  • Hospital Vall d'Hebron
  • Hospital Clinico San Carlos
  • Hospital General de Valencia
  • Chernivtsi Regional Clinical Hospital
  • National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovsky
  • National Research Centre for Radiation Medicine of The National Academy of Medical Sciences of UKR
  • Ternopil Municipal City Hosipital 2
  • Medical Centre Pulse
  • Papworth Hospital NHS Foundation Trust
  • Royal Devon and Exeter Hospital
  • Royal Brompton Hospital
  • Wythenshawe Hospital
  • University Hospital Southampton NHS Foundation Trust
  • Glenfield Hospital
  • Aintree Unversity Hospital NHS Foundation Trust
  • Newcastle Royal Victoria Infirmary
  • Nottingham City Hospital
  • Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital (RHH)
  • Birmingham Heartlands Hospital
  • Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital
  • Royal Infirmary of Edinburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A. GB0139 3 mg once a day

B. Placebo once a day

Arm Description

Inhalation of GB0139

Inhalation of Placebo

Outcomes

Primary Outcome Measures

Annual rate of decline in Forced Vital Capacity (FVC)
Efficacy of GB0139 as measured by the annual rate of decline in FVC expressed in mL

Secondary Outcome Measures

Absolute decline in FVC >10%
Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of > 10%
Time to first hospitalization
Time to first hospitalization (respiratory related, including acute exacerbation of IPF) expressed in days.
Time to death
Time to death from all-causes, respiratory-related causes and/or caused by IPF expressed in days
Assessment of Respiratory Related Quality of Life using the St. George's Respiratory Questionnaire (SGRQ)
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.

Full Information

First Posted
February 4, 2019
Last Updated
May 24, 2023
Sponsor
Galecto Biotech AB
Collaborators
Syneos Health, bioRASI, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03832946
Brief Title
A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
May 17, 2023 (Actual)
Study Completion Date
May 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galecto Biotech AB
Collaborators
Syneos Health, bioRASI, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis (IPF)
Keywords
TD139, Idiopathic pulmonary fibrosis, Galectin-3 inhibitor, GB0139

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This study is a double-blind study. The blinding will be maintained throughout the study.
Allocation
Randomized
Enrollment
426 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A. GB0139 3 mg once a day
Arm Type
Experimental
Arm Description
Inhalation of GB0139
Arm Title
B. Placebo once a day
Arm Type
Placebo Comparator
Arm Description
Inhalation of Placebo
Intervention Type
Drug
Intervention Name(s)
GB0139
Other Intervention Name(s)
TD139
Intervention Description
GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is administered as inhalation once a day
Primary Outcome Measure Information:
Title
Annual rate of decline in Forced Vital Capacity (FVC)
Description
Efficacy of GB0139 as measured by the annual rate of decline in FVC expressed in mL
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Absolute decline in FVC >10%
Description
Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of > 10%
Time Frame
52 weeks
Title
Time to first hospitalization
Description
Time to first hospitalization (respiratory related, including acute exacerbation of IPF) expressed in days.
Time Frame
52 weeks
Title
Time to death
Description
Time to death from all-causes, respiratory-related causes and/or caused by IPF expressed in days
Time Frame
52 weeks
Title
Assessment of Respiratory Related Quality of Life using the St. George's Respiratory Questionnaire (SGRQ)
Description
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.
Time Frame
52 weeks
Other Pre-specified Outcome Measures:
Title
Absolute decline in FVC >5%
Description
Percentage of subjects with an absolute decline from baseline in FVC (% predicted) of > 5%
Time Frame
52 weeks
Title
6-minute walk test (6MWT) distance
Description
Change from baseline in distance walked (metres) over 6 minutes
Time Frame
52 weeks
Title
Diffusion capacity of the lung for carbon monoxide (DLCO)
Description
Change from baseline in DLCO, corrected for Hemaglobin (mmol/min/kPa)
Time Frame
52 weeks
Title
Assessment of Dyspnea using the University of California San Diego - Shortness of Breath Questionnaire (UCSD - SOBQ)
Description
Change from baseline in UCSD - SOBQ Scored from 0-120 where a higher score indicates worse dyspnea
Time Frame
Weeks 12, 26 and 52
Title
Assessment of Health Related Quality of Life (HRQoL) using the Short-Form 36-Item Health Survey (SF-36)
Description
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
Time Frame
Weeks 12, 26 and 52
Title
Frequency of Adverse Events (AE) or Serious Adverse Events (SAE)
Description
Percentage of subjects with Adverse Events (AE) or Serious Adverse Events (SAE)
Time Frame
52 weeks
Title
Time to hospitalization
Description
Time in days to first hospitalization from all causes
Time Frame
52 weeks
Title
Time to hospitalization
Description
Time in days to first hospitalization (IPF related, including acute exacerbation of IPF)
Time Frame
52 weeks
Title
Time to respiratory related death
Description
Time in days to death from respiratory related causes (including IPF)
Time Frame
52 weeks
Title
Time to initiation of pirfenidone or nintedanib treatment
Description
Time in days to initiation of pirfenidone or nintedanib treatment in subjects not treated with pirfenidone or nintedanib at time of enrolment
Time Frame
52 weeks
Title
Annual rate of decline in FVC in subjects never treated with pirfenidone or nintedanib
Description
Change in FVC expressed in mL for subjects who have never been treated with pirfenidone or nintedanib
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Lung function parameters as follows: Forced Vital Capacity (FVC) > 45% of the predicted value at screening Diffusion lung capacity for carbon monoxide (DLCO) (corrected for Hb) of 30% to 79% of the predicted value at screening Subjects who currently are not being treated with nintedanib or pirfenidone; or cannot tolerate nintedanib or pirfenidone 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: Currently has significant airways obstruction: Forced Expiratory Volume in 1 s (FEV1)/Forced Vital Capacity (FVC) ratio of < 0.7 at screening. Has clinical evidence of active infection, including, but not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis. 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. 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. 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. Is likely to receive lung transplantation within the next 12 months. 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. Prior use of GB0139 (also called TD139) or previously randomized in GALACTIC-1. Prior use of nintedanib or pirfenidone within 7 days of initiation of screening. Prior use of investigational drugs within 30 days (or 5 half-lives, whichever is longer) of initiation of screening. Participating in another clinical trial, either interventional or observational. 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: Unstable angina pectoris or myocardial infarction, or percutaneous coronary intervention within the last 6 months Congestive heart failure requiring hospitalization Uncontrolled clinically significant arrhythmias 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. Woman considered to be of childbearing potential who do not use highly effective birth control methods during the study. Hypersensitivity to the active substance (TD139/GB0139) or the excipient (lactose).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toby Maher, MD, PhD
Organizational Affiliation
Keck Medicine of USC
Official's Role
Principal Investigator
Facility Information:
Facility Name
SEC Clinical Research
City
Andalusia
State/Province
Alabama
ZIP/Postal Code
36420-5310
Country
United States
Facility Name
Jasper Summit Research, LLC Pulmonary & Sleep Associates
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Facility Name
Palmtree Clinical Research Inc
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262-4871
Country
United States
Facility Name
Paradigm Research
City
Redding
State/Province
California
ZIP/Postal Code
96001-0172
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8057
Country
United States
Facility Name
Health Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Harmony Medical Research Institute, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Advanced Research for Health Improvement
City
Naples
State/Province
Florida
ZIP/Postal Code
34109
Country
United States
Facility Name
Broward Research Centre
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Avanza Medical Research Centre
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Coastal Pulmonary Critical Care PLC
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33704
Country
United States
Facility Name
Tampa General Hospital/Uni Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Piedmont Healthcare Pulmonary and Critical Care Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
DC Research Works
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060-7297
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
97232
Country
United States
Facility Name
LaPorte County Institute for Clinical Research
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360-9330
Country
United States
Facility Name
University of Kansas Medical Centre
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Harvard Medical School - Brigham and Womens Hospital (BWH)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
The Lung Research Center LLC
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
Pulmonlx LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45276
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2650
Country
United States
Facility Name
University of Texas Health Centre at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Sciences Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah Health Scieces Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
TPMG Clinical Research
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23188
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Lung Research QLD
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Flinders Medical Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Respiratory Clinical Trials
City
Kent Town
State/Province
South Australia
ZIP/Postal Code
5067
Country
Australia
Facility Name
Institute for Respiratory Health Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
TrialsWest
City
Spearwood
State/Province
Western Australia
ZIP/Postal Code
6163
Country
Australia
Facility Name
Cliniques Universitaires St-Luc
City
Louvain-la-Neuve
State/Province
Wallon Region
ZIP/Postal Code
1348
Country
Belgium
Facility Name
UZ Antwerp
City
Antwerp
Country
Belgium
Facility Name
CUB Hopital Erasme
City
Brussels
ZIP/Postal Code
1400
Country
Belgium
Facility Name
UZ Leuven- Campus Gasthuisberg
City
Brussels
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU UCL Namur site Godinne
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Firestone Institute for Respiratory Health
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Dr Anees Medicine Professional Corporation
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 1T3
Country
Canada
Facility Name
Dr Dhar Medical Practice
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
Toronto General Hosp Research Inst
City
Toronto
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Groupe Hospitalier Hopitaux Universitaires Paris-Seine-Saint-Denis-Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
CHRU Lille - Hopital Calmette
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hopital Nord de Marseille
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
APHP - Hopital Europen Georges-Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Bichat
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU de la Réunion Site SUD (Terre Sainte)
City
Saint Pierre
ZIP/Postal Code
97410
Country
France
Facility Name
CHU de la Réunion- Site Félix Guyon
City
Saint-Pierre
ZIP/Postal Code
97410
Country
France
Facility Name
Hopitaux Universitaires de Strasborg Service de Pneumologie Nouvel Hopital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Centre Hospitalier Rgional et Universitaire - Hopital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Chapidze Emergency Cardiology Center
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
The First Medical Center
City
Tbilisi
ZIP/Postal Code
0180
Country
Georgia
Facility Name
Thoraxklinik-Heidelberg gGmbH
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Lungenfachklinik Immenhausen Department for Clinical Studies
City
Immenhausen
State/Province
Hessen
ZIP/Postal Code
34376
Country
Germany
Facility Name
ZMS Zentrum für medizinische Studien GmbH
City
Warendorf
State/Province
Rhine-Westphalia
ZIP/Postal Code
48231
Country
Germany
Facility Name
Klifeck GmbH Praxis Med. Gerald Eckhardt
City
Delitzsch
State/Province
Sachsen
ZIP/Postal Code
04509
Country
Germany
Facility Name
Studienzentrum Dr.med Falk Brunner FA fuer Innere Medizin und Pneumologie
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04157
Country
Germany
Facility Name
CIMS Studienzentrum Bamberg GmbH
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Facility Name
Krankenhaus Donaustauf
City
Donaustauf
ZIP/Postal Code
93093
Country
Germany
Facility Name
Ruhrlandklinik Essen
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Universitaetsklinikum Leipzig Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, P
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
POIS Leipzig GbR
City
Leipzig
ZIP/Postal Code
04357
Country
Germany
Facility Name
Klinikum Grossadern der Ludwig-Maximilians-Universitaet Muenchen
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Trinity Centre for Health Sciences
City
Dublin
ZIP/Postal Code
D24NROA
Country
Ireland
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Name
Meir Medical Center
City
Kefar Sava
ZIP/Postal Code
44281
Country
Israel
Facility Name
Pulmonary Institute Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Facility Name
Kaplan Medical Center
City
Reẖovot
Country
Israel
Facility Name
University-Hospital Policlinico Vittorio Emanuele
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale San Giuseppe Clinica Malattie dell Apparato Respiratorio
City
MIlan
ZIP/Postal Code
20123
Country
Italy
Facility Name
University Hospital of Mondena-AOU - Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
A.O. Dei Colli OSPEDALE MONALDI
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale GB Morgagni
City
Padova
ZIP/Postal Code
35100
Country
Italy
Facility Name
Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
AOU Città della Salute e della Scienza, PO Molinette
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
City
Łódź
State/Province
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc
City
Warszawa
State/Province
Mazovia
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Oddział Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie
City
Kraków
State/Province
Małopolskie
ZIP/Postal Code
30688
Country
Poland
Facility Name
Klinika Alergologii Pneumonologii
City
Gdańsk
State/Province
Pomerania
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
City
Poznań
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Univ. Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Lucas Augusti
City
Lugo
State/Province
Galicia
ZIP/Postal Code
27003
Country
Spain
Facility Name
Hospital Universitario Quiron Madrid
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Policlinica Barcelona
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hopital de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital General de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Chernivtsi Regional Clinical Hospital
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovsky
City
Kyiv
ZIP/Postal Code
03038
Country
Ukraine
Facility Name
National Research Centre for Radiation Medicine of The National Academy of Medical Sciences of UKR
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Ternopil Municipal City Hosipital 2
City
Ternopil
ZIP/Postal Code
46023
Country
Ukraine
Facility Name
Medical Centre Pulse
City
Vinnytsya
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
Papworth Hospital NHS Foundation Trust
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0AY
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Glenfield Hospital
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Aintree Unversity Hospital NHS Foundation Trust
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Newcastle Royal Victoria Infirmary
City
Newcastle Upon Tyne
State/Province
Newcastle
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital (RHH)
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35120836
Citation
Rebelo AL, Chevalier MT, Russo L, Pandit A. Role and therapeutic implications of protein glycosylation in neuroinflammation. Trends Mol Med. 2022 Apr;28(4):270-289. doi: 10.1016/j.molmed.2022.01.004. Epub 2022 Feb 1.
Results Reference
derived
PubMed Identifier
33072090
Citation
Park AM, Khadka S, Sato F, Omura S, Fujita M, Hsu DK, Liu FT, Tsunoda I. Galectin-3 as a Therapeutic Target for NSAID-Induced Intestinal Ulcers. Front Immunol. 2020 Sep 23;11:550366. doi: 10.3389/fimmu.2020.550366. eCollection 2020.
Results Reference
derived

Learn more about this trial

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

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