A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
- Registration Number
- NCT03832946
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 172
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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.
-
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.
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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.
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Is likely to receive lung transplantation within the next 12 months.
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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.
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Prior use of GB0139 (also called TD139) or previously randomized in GALACTIC-1.
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Prior use of nintedanib or pirfenidone within 7 days of initiation of screening.
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Prior use of investigational drugs within 30 days (or 5 half-lives, whichever is longer) of initiation of screening.
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Participating in another clinical trial, either interventional or observational.
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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
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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.
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Woman considered to be of childbearing potential who do not use highly effective birth control methods during the study.
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Hypersensitivity to the active substance (TD139/GB0139) or the excipient (lactose).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A. GB0139 3 mg once a day GB0139 Inhalation of GB0139 B. Placebo once a day Placebo Inhalation of Placebo
- Primary Outcome Measures
Name Time Method Annual Rate of Decline in Forced Vital Capacity (FVC) 52 weeks Efficacy of GB0139 as measured by the annual rate of decline in FVC expressed in mL
- Secondary Outcome Measures
Name Time Method Assessment of Respiratory Related Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ) 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.
Number of Participants With Respiratory Related Hospitalizations 52 weeks Number of Participants with Respiratory Related Hospitalizations from randomisation (including acute exacerbation of IPF).
Trial Locations
- Locations (128)
Harvard Medical School - Brigham and Womens Hospital (BWH)
🇺🇸Boston, Massachusetts, United States
University of Texas Health Sciences Center at Houston
🇺🇸Houston, Texas, United States
University of Texas Health Centre at Houston
🇺🇸Houston, Texas, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Royal Devon and Exeter Hospital
🇬🇧Exeter, Devon, United Kingdom
University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, Hampshire, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Glenfield Hospital
🇬🇧Leicester, Leicestershire, United Kingdom
Papworth Hospital NHS Foundation Trust
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Jasper Summit Research, LLC Pulmonary & Sleep Associates
🇺🇸Jasper, Alabama, United States
Advanced Research for Health Improvement
🇺🇸Naples, Florida, United States
Palmtree Clinical Research Inc
🇺🇸Palm Springs, California, United States
Paradigm Research
🇺🇸Redding, California, United States
Harmony Medical Research Institute, Inc
🇺🇸Hialeah, Florida, United States
Avanza Medical Research Centre
🇺🇸Pensacola, Florida, United States
Broward Research Centre
🇺🇸Pembroke Pines, Florida, United States
Coastal Pulmonary Critical Care PLC
🇺🇸Saint Petersburg, Florida, United States
Piedmont Healthcare Pulmonary and Critical Care Research
🇺🇸Atlanta, Georgia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Kansas Medical Centre
🇺🇸Kansas City, Kansas, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
The Lung Research Center LLC
🇺🇸Chesterfield, Missouri, United States
Pulmonlx LLC
🇺🇸Greensboro, North Carolina, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, 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
Lung Research QLD
🇦🇺Chermside, Queensland, Australia
Respiratory Clinical Trials
🇦🇺Kent Town, South Australia, Australia
Institute for Respiratory Health Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Flinders Medical Centre
🇦🇺Adelaide, South Australia, Australia
Dr Anees Medicine Professional Corporation
🇨🇦Windsor, Ontario, Canada
Cliniques Universitaires St-Luc
🇧🇪Louvain-la-Neuve, Wallon Region, Belgium
CHU UCL Namur site Godinne
🇧🇪Namur, Belgium
UZ Antwerp
🇧🇪Antwerp, Belgium
CUB Hopital Erasme
🇧🇪Brussels, Belgium
UZ Leuven- Campus Gasthuisberg
🇧🇪Brussels, Belgium
Firestone Institute for Respiratory Health
🇨🇦Hamilton, 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
Hopitaux Universitaires de Strasborg Service de Pneumologie Nouvel Hopital Civil
🇫🇷Strasbourg, 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
The First Medical Center
🇬🇪Tbilisi, Georgia
Chapidze Emergency Cardiology Center
🇬🇪Tbilisi, Georgia
Krankenhaus Donaustauf
🇩🇪Donaustauf, Germany
CIMS Studienzentrum Bamberg GmbH
🇩🇪Bamberg, Germany
Thoraxklinik-Heidelberg gGmbH
🇩🇪Heidelberg, Baden-Württemberg, Germany
ZMS Zentrum für medizinische Studien GmbH
🇩🇪Warendorf, Rhine-Westphalia, Germany
Studienzentrum Dr.med Falk Brunner FA fuer Innere Medizin und Pneumologie
🇩🇪Leipzig, Saxony, Germany
Klifeck GmbH Praxis Med. Gerald Eckhardt
🇩🇪Delitzsch, Sachsen, Germany
Ruhrlandklinik Essen
🇩🇪Essen, Germany
Klinikum Grossadern der Ludwig-Maximilians-Universitaet Muenchen
🇩🇪Munich, Germany
Universitaetsklinikum Leipzig Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, P
🇩🇪Leipzig, Germany
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Meir Medical Center
🇮🇱Kefar Sava, Israel
Trinity Centre for Health Sciences
🇮🇪Dublin, Ireland
Kaplan Medical Center
🇮🇱Reẖovot, Israel
University-Hospital Policlinico Vittorio Emanuele
🇮🇹Catania, Italy
University Hospital of Mondena-AOU - Policlinico di Modena
🇮🇹Modena, Italy
Ospedale San Giuseppe Clinica Malattie dell Apparato Respiratorio
🇮🇹MIlan, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
A.O. Dei Colli OSPEDALE MONALDI
🇮🇹Napoli, Italy
Ospedale GB Morgagni
🇮🇹Padova, 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
Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
🇵🇱Łódź, Lodz, Poland
Klinika Alergologii Pneumonologii
🇵🇱Gdańsk, Pomerania, Poland
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
🇵🇱Poznań, Poland
Regional Clinical Hospital No. 3
🇷🇺Chelyabinsk, Russian Federation
Pulmonology Scientific Research Institute
🇷🇺Moscow, Russian Federation
Kazan SMU, Republican Clinical Hospital of MOH, Republic of Tatarstan
🇷🇺Kazan, Russian Federation
Pavlov First Saint Petersburg State Medical University
🇷🇺Saint Petersburg, Russian Federation
Evdokimov Moscow State University of Medicine and Dentistry
🇷🇺Moscow, Russian Federation
Soloviev Clinical Emergency Hospital
🇷🇺Yaroslavl, Russian Federation
LLC "Medical Association Novaya Bolnitsa"
🇷🇺Yekaterinburg, Russian Federation
Hospital Univ. Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
Policlinica Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Lucas Augusti
🇪🇸Lugo, Galicia, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hopital de Bellvitge
🇪🇸Barcelona, Spain
Hospital General de Valencia
🇪🇸Valencia, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Chernivtsi Regional Clinical Hospital
🇺🇦Chernivtsi, 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
National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovsky
🇺🇦Kyiv, Ukraine
Medical Centre Pulse
🇺🇦Vinnytsya, Ukraine
Wythenshawe Hospital
🇬🇧Manchester, Greater Manchester, United Kingdom
Aintree Unversity Hospital NHS Foundation Trust
🇬🇧Liverpool, Merseyside, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital (RHH)
🇬🇧Sheffield, South Yorkshire, United Kingdom
Newcastle Royal Victoria Infirmary
🇬🇧Newcastle Upon Tyne, Newcastle, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Tampa General Hospital/Uni Florida
🇺🇸Tampa, Florida, United States
Lungenfachklinik Immenhausen Department for Clinical Studies
🇩🇪Immenhausen, Hessen, Germany
LaPorte County Institute for Clinical Research
🇺🇸Michigan City, Indiana, United States
DC Research Works
🇺🇸Marietta, Georgia, United States
TrialsWest
🇦🇺Spearwood, Western Australia, Australia
Hopital Bichat
🇫🇷Paris, France
APHP - Hopital Europen Georges-Pompidou
🇫🇷Paris, France
Centre Hospitalier Rgional et Universitaire - Hopital Bretonneau
🇫🇷Tours, France
POIS Leipzig GbR
🇩🇪Leipzig, Germany
Pulmonary Institute Rabin Medical Center
🇮🇱Petah Tikva, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Oddział Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie
🇵🇱Kraków, Małopolskie, Poland
Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc
🇵🇱Warszawa, Mazovia, Poland
OLLA-MED
🇷🇺Moscow, Russian Federation
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital Universitario Quiron Madrid
🇪🇸Pozuelo De Alarcón, Madrid, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital
🇬🇧Bristol, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, West Midlands, United Kingdom
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Health Shands Hospital
🇺🇸Gainesville, Florida, United States
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States
SEC Clinical Research
🇺🇸Andalusia, Alabama, United States
Royal Brompton Hospital
🇬🇧London, Greater London, United Kingdom
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States