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A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 40 Years and Over |
Gender | All |
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).Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03832946 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Galecto Biotech AB |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Toby Maher, MD, PhD |
Principal Investigator Affiliation | Keck Medicine of USC |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry, Other |
Overall Status | Recruiting |
Countries | Australia, Belgium, Canada, France, Georgia, Germany, Ireland, Israel, Italy, Poland, Spain, Ukraine, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Idiopathic Pulmonary Fibrosis (IPF) |
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.
Arms
Experimental: A. GB0139 3 mg once a day
Inhalation of GB0139
Placebo Comparator: B. Placebo once a day
Inhalation of Placebo
Interventions
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.
Drug: - Placebo
Placebo is administered as inhalation once a day
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Active, not recruiting
Address
SEC Clinical Research
Andalusia, Alabama, 36420-5310
Status
Recruiting
Address
Jasper Summit Research, LLC Pulmonary & Sleep Associates
Jasper, Alabama, 35501
Status
Active, not recruiting
Address
Palmtree Clinical Research Inc
Palm Springs, California, 92262-4871
Status
Active, not recruiting
Address
Paradigm Research
Redding, California, 96001-0172
Status
Active, not recruiting
Address
Yale University School of Medicine
New Haven, Connecticut, 06520-8057
Status
Recruiting
Address
Health Shands Hospital
Gainesville, Florida, 32611
Status
Recruiting
Address
Harmony Medical Research Institute, Inc
Hialeah, Florida, 33016
Status
Active, not recruiting
Address
Advanced Research for Health Improvement
Naples, Florida, 34109
Status
Recruiting
Address
Broward Research Centre
Pembroke Pines, Florida, 33024
Status
Recruiting
Address
Avanza Medical Research Centre
Pensacola, Florida, 32503
Status
Recruiting
Address
Coastal Pulmonary Critical Care PLC
Saint Petersburg, Florida, 33704
Status
Recruiting
Address
Tampa General Hospital/Uni Florida
Tampa, Florida, 33606
Status
Recruiting
Address
Piedmont Healthcare Pulmonary and Critical Care Research
Atlanta, Georgia, 30309
Status
Recruiting
Address
The Emory Clinic
Atlanta, Georgia, 30322
Status
Recruiting
Address
DC Research Works
Marietta, Georgia, 30060-7297
Status
Recruiting
Address
Northwestern Memorial Hospital
Chicago, Illinois, 97232
Status
Active, not recruiting
Address
LaPorte County Institute for Clinical Research
Michigan City, Indiana, 46360-9330
Status
Recruiting
Address
University of Kansas Medical Centre
Kansas City, Kansas, 66160
Status
Active, not recruiting
Address
University of Louisville Hospital
Louisville, Kentucky, 40202
Status
Recruiting
Address
University of Maryland
Baltimore, Maryland, 21201
Status
Active, not recruiting
Address
Harvard Medical School - Brigham and Womens Hospital (BWH)
Boston, Massachusetts, 02115
Status
Recruiting
Address
The Lung Research Center LLC
Chesterfield, Missouri, 63017
Status
Active, not recruiting
Address
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Status
Active, not recruiting
Address
Pulmonlx LLC
Greensboro, North Carolina, 27403
Status
Recruiting
Address
University of Cincinnati
Cincinnati, Ohio, 45276
Status
Active, not recruiting
Address
The Cleveland Clinic Foundation
Cleveland, Ohio, 44109
Status
Active, not recruiting
Address
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Status
Active, not recruiting
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2650
Status
Active, not recruiting
Address
University of Texas Health Centre at Houston
Houston, Texas, 77030
Status
Recruiting
Address
University of Texas Health Sciences Center at Houston
Houston, Texas, 77030
Status
Recruiting
Address
Diagnostics Research Group
San Antonio, Texas, 78229
Status
Active, not recruiting
Address
University of Utah Health Scieces Center
Salt Lake City, Utah, 84108
Status
Recruiting
Address
TPMG Clinical Research
Williamsburg, Virginia, 23188
Status
Active, not recruiting
Address
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
International Sites
Status
Active, not recruiting
Address
Lung Research QLD
Chermside, Queensland, 4032
Status
Recruiting
Address
Flinders Medical Centre
Adelaide, South Australia, 5042
Status
Recruiting
Address
Respiratory Clinical Trials
Kent Town, South Australia, 5067
Status
Active, not recruiting
Address
Institute for Respiratory Health Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Status
Recruiting
Address
TrialsWest
Spearwood, Western Australia, 6163
Status
Active, not recruiting
Address
Cliniques Universitaires St-Luc
Louvain-la-Neuve, Wallon Region, 1348
Status
Active, not recruiting
Address
UZ Antwerp
Antwerp, ,
Status
Active, not recruiting
Address
CUB Hopital Erasme
Brussels, , 1400
Status
Active, not recruiting
Address
UZ Leuven- Campus Gasthuisberg
Brussels, , 3000
Status
Active, not recruiting
Address
CHU UCL Namur site Godinne
Namur, , 5000
Status
Active, not recruiting
Address
Firestone Institute for Respiratory Health
Hamilton, Ontario, L8N 4A6
Status
Active, not recruiting
Address
Dr Anees Medicine Professional Corporation
Windsor, Ontario, N8X 1T3
Status
Active, not recruiting
Address
Dr Dhar Medical Practice
Windsor, Ontario, N8X 5A6
Status
Active, not recruiting
Address
Toronto General Hosp Research Inst
Toronto, , M5T 2S8
Status
Recruiting
Address
Groupe Hospitalier Hopitaux Universitaires Paris-Seine-Saint-Denis-Hopital Avicenne
Bobigny, , 93000
Status
Recruiting
Address
CHRU Lille - Hopital Calmette
Lille, , 59000
Status
Recruiting
Address
Hopital Nord de Marseille
Marseille, , 13015
Status
Recruiting
Address
APHP - Hopital Europen Georges-Pompidou
Paris, , 75015
Status
Active, not recruiting
Address
Hopital Bichat
Paris, , 75877
Status
Recruiting
Address
Centre Hospitalier Universitaire de Rennes Hopital Pontchaillou
Rennes, , 35033
Status
Recruiting
Address
CHU de la Réunion Site SUD (Terre Sainte)
Saint Pierre, , 97410
Status
Recruiting
Address
CHU de la Réunion- Site Félix Guyon
Saint-Pierre, , 97410
Status
Recruiting
Address
Hopitaux Universitaires de Strasborg Service de Pneumologie Nouvel Hopital Civil
Strasbourg, , 67091
Status
Active, not recruiting
Address
Centre Hospitalier Rgional et Universitaire - Hopital Bretonneau
Tours, , 37044
Status
Recruiting
Address
Chapidze Emergency Cardiology Center
Tbilisi, , 0159
Status
Recruiting
Address
The First Medical Center
Tbilisi, , 0180
Status
Recruiting
Address
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Württemberg, 69126
Status
Recruiting
Address
Lungenfachklinik Immenhausen Department for Clinical Studies
Immenhausen, Hessen, 34376
Status
Recruiting
Address
ZMS Zentrum für medizinische Studien GmbH
Warendorf, Rhine-Westphalia, 48231
Status
Recruiting
Address
Klifeck GmbH Praxis Med. Gerald Eckhardt
Delitzsch, Sachsen, 04509
Status
Recruiting
Address
Studienzentrum Dr.med Falk Brunner FA fuer Innere Medizin und Pneumologie
Leipzig, Saxony, 04157
Status
Recruiting
Address
CIMS Studienzentrum Bamberg GmbH
Bamberg, , 96049
Status
Recruiting
Address
Krankenhaus Donaustauf
Donaustauf, , 93093
Status
Recruiting
Address
Ruhrlandklinik Essen
Essen, , 45239
Status
Recruiting
Address
Universitaetsklinikum Leipzig Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, P
Leipzig, , 04103
Status
Recruiting
Address
POIS Leipzig GbR
Leipzig, , 04357
Status
Recruiting
Address
Klinikum Grossadern der Ludwig-Maximilians-Universitaet Muenchen
Munich, , 81377
Status
Recruiting
Address
Trinity Centre for Health Sciences
Dublin, , D24NROA
Status
Recruiting
Address
Hadassah Medical Center
Jerusalem, ,
Status
Recruiting
Address
Meir Medical Center
Kefar Sava, , 44281
Status
Recruiting
Address
Pulmonary Institute Rabin Medical Center
Petah Tikva, , 4941492
Status
Recruiting
Address
Sheba Medical Center
Ramat Gan, ,
Status
Recruiting
Address
Kaplan Medical Center
Reẖovot, ,
Status
Active, not recruiting
Address
University-Hospital Policlinico Vittorio Emanuele
Catania, , 95123
Status
Active, not recruiting
Address
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , 20122
Status
Active, not recruiting
Address
Ospedale San Giuseppe Clinica Malattie dell Apparato Respiratorio
MIlan, , 20123
Status
Active, not recruiting
Address
University Hospital of Mondena-AOU - Policlinico di Modena
Modena, , 41124
Status
Active, not recruiting
Address
A.O. Dei Colli OSPEDALE MONALDI
Napoli, , 80131
Status
Active, not recruiting
Address
Ospedale GB Morgagni
Padova, , 35100
Status
Active, not recruiting
Address
Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
Palermo, , 90127
Status
Active, not recruiting
Address
Azienda Ospedaliera Universitaria Senese
Siena, , 53100
Status
Active, not recruiting
Address
AOU Città della Salute e della Scienza, PO Molinette
Turin, , 10126
Status
Active, not recruiting
Address
Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Łódź, Lodz, 90-153
Status
Active, not recruiting
Address
Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc
Warszawa, Mazovia, 01-138
Status
Recruiting
Address
Oddział Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie
Kraków, Małopolskie, 30688
Status
Recruiting
Address
Klinika Alergologii Pneumonologii
Gdańsk, Pomerania, 80-214
Status
Active, not recruiting
Address
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznań, , 60-569
Status
Recruiting
Address
Hospital Universitario Central de Asturias
Oviedo, Asturias, 33011
Status
Recruiting
Address
Hospital Univ. Marques de Valdecilla
Santander, Cantabria, 39008
Status
Active, not recruiting
Address
Hospital Universitario Lucas Augusti
Lugo, Galicia, 27003
Status
Recruiting
Address
Hospital Universitario Quiron Madrid
Pozuelo De Alarcón, Madrid, 28223
Status
Recruiting
Address
Policlinica Barcelona
Barcelona, , 08006
Status
Recruiting
Address
Hospital Clinic de Barcelona
Barcelona, , 08036
Status
Recruiting
Address
Hospital de la Santa Creu i Sant Pau
Barcelona, , 08041
Status
Recruiting
Address
Hopital de Bellvitge
Barcelona, , 08907
Status
Recruiting
Address
Hospital Vall d'Hebron
Barcelona, , 8035
Status
Recruiting
Address
Hospital Clinico San Carlos
Madrid, ,
Status
Recruiting
Address
Hospital General de Valencia
Valencia, , 46014
Status
Recruiting
Address
Chernivtsi Regional Clinical Hospital
Chernivtsi, , 58001
Status
Recruiting
Address
National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovsky
Kyiv, , 03038
Status
Recruiting
Address
National Research Centre for Radiation Medicine of The National Academy of Medical Sciences of UKR
Kyiv, , 03115
Status
Recruiting
Address
Ternopil Municipal City Hosipital 2
Ternopil, , 46023
Status
Recruiting
Address
Medical Centre Pulse
Vinnytsya, , 21001
Status
Recruiting
Address
Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0AY
Status
Active, not recruiting
Address
Royal Devon and Exeter Hospital
Exeter, Devon, EX2 5DW
Status
Recruiting
Address
Royal Brompton Hospital
London, Greater London, SW3 6NP
Status
Recruiting
Address
Wythenshawe Hospital
Manchester, Greater Manchester, M23 9LT
Status
Recruiting
Address
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
Status
Recruiting
Address
Glenfield Hospital
Leicester, Leicestershire, LE3 9QP
Status
Recruiting
Address
Aintree Unversity Hospital NHS Foundation Trust
Liverpool, Merseyside, L9 7AL
Status
Recruiting
Address
Newcastle Royal Victoria Infirmary
Newcastle Upon Tyne, Newcastle, NE1 4LP
Status
Recruiting
Address
Nottingham City Hospital
Nottingham, Nottinghamshire, NG5 1PB
Status
Completed
Address
Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital (RHH)
Sheffield, South Yorkshire, S5 7AU
Status
Recruiting
Address
Birmingham Heartlands Hospital
Birmingham, West Midlands, B9 5SS
Status
Active, not recruiting
Address
Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital
Bristol, , BS10 5NB
Status
Recruiting
Address
Royal Infirmary of Edinburgh
Edinburgh, , EH16 4SA