A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
NCT ID: NCT03832946
Last Updated: 2024-05-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
172 participants
INTERVENTIONAL
2019-02-19
2023-05-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
A. GB0139 3 mg once a day B. Placebo once a day
TREATMENT
QUADRUPLE
Study Groups
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A. GB0139 3 mg once a day
Inhalation of GB0139
GB0139
GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.
B. Placebo once a day
Inhalation of Placebo
Placebo
Placebo is administered as inhalation once a day
Interventions
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GB0139
GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.
Placebo
Placebo is administered as inhalation once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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).
40 Years
ALL
No
Sponsors
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Syneos Health
OTHER
bioRASI, LLC
INDUSTRY
Galecto Biotech AB
INDUSTRY
Responsible Party
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Principal Investigators
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Toby Maher, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Keck Medicine of USC
Locations
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SEC Clinical Research
Andalusia, Alabama, United States
Jasper Summit Research, LLC Pulmonary & Sleep Associates
Jasper, Alabama, United States
Palmtree Clinical Research Inc
Palm Springs, California, United States
Paradigm Research
Redding, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Health Shands Hospital
Gainesville, Florida, United States
Harmony Medical Research Institute, Inc
Hialeah, Florida, United States
Advanced Research for Health Improvement
Naples, Florida, United States
Broward Research Centre
Pembroke Pines, Florida, United States
Avanza Medical Research Centre
Pensacola, Florida, United States
Coastal Pulmonary Critical Care PLC
St. Petersburg, Florida, United States
Tampa General Hospital/Uni Florida
Tampa, Florida, United States
Piedmont Healthcare Pulmonary and Critical Care Research
Atlanta, Georgia, United States
The Emory Clinic
Atlanta, Georgia, United States
DC Research Works
Marietta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
LaPorte County Institute for Clinical Research
Michigan City, Indiana, United States
University of Kansas Medical Centre
Kansas City, Kansas, United States
University of Louisville Hospital
Louisville, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Harvard Medical School - Brigham and Womens Hospital (BWH)
Boston, Massachusetts, United States
The Lung Research Center LLC
Chesterfield, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Pulmonlx LLC
Greensboro, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Health Centre at Houston
Houston, Texas, United States
University of Texas Health Sciences Center at Houston
Houston, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
University of Utah Health Scieces Center
Salt Lake City, Utah, United States
TPMG Clinical Research
Williamsburg, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Lung Research QLD
Chermside, Queensland, Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Respiratory Clinical Trials
Kent Town, South Australia, Australia
Institute for Respiratory Health Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
TrialsWest
Spearwood, Western Australia, Australia
Cliniques Universitaires St-Luc
Louvain-la-Neuve, Wallon Region, Belgium
UZ Antwerp
Antwerp, , Belgium
CUB Hopital Erasme
Brussels, , Belgium
UZ Leuven- Campus Gasthuisberg
Brussels, , Belgium
CHU UCL Namur site Godinne
Namur, , Belgium
Firestone Institute for Respiratory Health
Hamilton, Ontario, Canada
Dr Anees Medicine Professional Corporation
Windsor, Ontario, Canada
Dr Dhar Medical Practice
Windsor, Ontario, Canada
Toronto General Hosp Research Inst
Toronto, , Canada
Groupe Hospitalier Hopitaux Universitaires Paris-Seine-Saint-Denis-Hopital Avicenne
Bobigny, , France
CHRU Lille - Hopital Calmette
Lille, , France
Hopital Nord de Marseille
Marseille, , France
APHP - Hopital Europen Georges-Pompidou
Paris, , France
Hopital Bichat
Paris, , France
Centre Hospitalier Universitaire de Rennes Hopital Pontchaillou
Rennes, , France
CHU de la Réunion Site SUD (Terre Sainte)
Saint-Pierre, , France
CHU de la Réunion- Site Félix Guyon
Saint-Pierre, , France
Hopitaux Universitaires de Strasborg Service de Pneumologie Nouvel Hopital Civil
Strasbourg, , France
Centre Hospitalier Rgional et Universitaire - Hopital Bretonneau
Tours, , France
Chapidze Emergency Cardiology Center
Tbilisi, , Georgia
The First Medical Center
Tbilisi, , Georgia
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, Germany
Lungenfachklinik Immenhausen Department for Clinical Studies
Immenhausen, Hesse, Germany
ZMS Zentrum für medizinische Studien GmbH
Warendorf, Rhine-Westphalia, Germany
Klifeck GmbH Praxis Med. Gerald Eckhardt
Delitzsch, Saxony, Germany
Studienzentrum Dr.med Falk Brunner FA fuer Innere Medizin und Pneumologie
Leipzig, Saxony, Germany
CIMS Studienzentrum Bamberg GmbH
Bamberg, , Germany
Krankenhaus Donaustauf
Donaustauf, , Germany
Ruhrlandklinik Essen
Essen, , Germany
Universitaetsklinikum Leipzig Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, P
Leipzig, , Germany
POIS Leipzig GbR
Leipzig, , Germany
Klinikum Grossadern der Ludwig-Maximilians-Universitaet Muenchen
Munich, , Germany
Trinity Centre for Health Sciences
Dublin, , Ireland
Hadassah Medical Center
Jerusalem, , Israel
Meir Medical Center
Kefar Sava, , Israel
Pulmonary Institute Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
University-Hospital Policlinico Vittorio Emanuele
Catania, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale San Giuseppe Clinica Malattie dell Apparato Respiratorio
Milan, , Italy
University Hospital of Mondena-AOU - Policlinico di Modena
Modena, , Italy
A.O. Dei Colli OSPEDALE MONALDI
Napoli, , Italy
Ospedale GB Morgagni
Padua, , Italy
Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
Palermo, , Italy
Azienda Ospedaliera Universitaria Senese
Siena, , Italy
AOU Città della Salute e della Scienza, PO Molinette
Turin, , Italy
Oddział Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc
Warsaw, Masovian Voivodeship, Poland
Klinika Alergologii Pneumonologii
Gdansk, Pomeranian Voivodeship, Poland
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, , Poland
Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, Łódź Voivodeship, Poland
Regional Clinical Hospital No. 3
Chelyabinsk, , Russia
Kazan SMU, Republican Clinical Hospital of MOH, Republic of Tatarstan
Kazan', , Russia
OLLA-MED
Moscow, , Russia
Pulmonology Scientific Research Institute
Moscow, , Russia
Evdokimov Moscow State University of Medicine and Dentistry
Moscow, , Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, , Russia
Soloviev Clinical Emergency Hospital
Yaroslavl, , Russia
LLC "Medical Association Novaya Bolnitsa"
Yekaterinburg, , Russia
Hospital Univ. Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Lucas Augusti
Lugo, Galicia, Spain
Hospital Universitario Quiron Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Policlinica Barcelona
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hopital de Bellvitge
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital General de Valencia
Valencia, , Spain
Chernivtsi Regional Clinical Hospital
Chernivtsi, , Ukraine
National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovsky
Kyiv, , Ukraine
National Research Centre for Radiation Medicine of The National Academy of Medical Sciences of UKR
Kyiv, , Ukraine
Ternopil Municipal City Hosipital 2
Ternopil, , Ukraine
Medical Centre Pulse
Vinnytsia, , Ukraine
Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
Royal Devon and Exeter Hospital
Exeter, Devon, United Kingdom
Royal Brompton Hospital
London, Greater London, United Kingdom
Wythenshawe Hospital
Manchester, Greater Manchester, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
Glenfield Hospital
Leicester, Leicestershire, United Kingdom
Aintree Unversity Hospital NHS Foundation Trust
Liverpool, Merseyside, United Kingdom
Newcastle Royal Victoria Infirmary
Newcastle upon Tyne, Newcastle, United Kingdom
Nottingham City Hospital
Nottingham, Nottinghamshire, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital (RHH)
Sheffield, South Yorkshire, United Kingdom
Birmingham Heartlands Hospital
Birmingham, West Midlands, United Kingdom
Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital
Bristol, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-002664-73
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GALACTIC-1
Identifier Type: -
Identifier Source: org_study_id
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