Clinical trial NCT03832946: A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Official title: A Randomized, 52 Week, 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis (IPF)
Keywords: TD139
Idiopathic pulmonary fibrosis
Galectin-3 inhibitor
GB0139
Lead sponsor: Galecto Biotech AB
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
name: bioRASI, LLC
First posted: 2019-02-06
Enrollment: 172
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Annual Rate of Decline in Forced Vital Capacity (FVC)
timeFrame: 52 weeks
Secondary outcomes:
measure: Number of Participants With Respiratory Related Hospitalizations
timeFrame: 52 weeks
measure: Assessment of Respiratory Related Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Andalusia
country: United States
facility: SEC Clinical Research
state: Alabama
city: Jasper
country: United States
facility: Jasper Summit Research, LLC Pulmonary & Sleep Associates
state: Alabama
city: Palm Springs
country: United States
facility: Palmtree Clinical Research Inc
state: California
city: Redding
country: United States
facility: Paradigm Research
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Gainesville
country: United States
facility: Health Shands Hospital
state: Florida
city: Hialeah
country: United States
facility: Harmony Medical Research Institute, Inc
state: Florida
city: Naples
country: United States
facility: Advanced Research for Health Improvement
state: Florida
city: Pembroke Pines
country: United States
facility: Broward Research Centre
state: Florida
city: Pensacola
country: United States
facility: Avanza Medical Research Centre
state: Florida
city: Saint Petersburg
country: United States
facility: Coastal Pulmonary Critical Care PLC
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital/Uni Florida
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare Pulmonary and Critical Care Research
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Marietta
country: United States
facility: DC Research Works
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Michigan City
country: United States
facility: LaPorte County Institute for Clinical Research
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Centre
state: Kansas
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Harvard Medical School - Brigham and Womens Hospital (BWH)
state: Massachusetts
city: Chesterfield
country: United States
facility: The Lung Research Center LLC
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Greensboro
country: United States
facility: Pulmonlx LLC
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Centre at Houston
state: Texas
city: Houston
country: United States
facility: University of Texas Health Sciences Center at Houston
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Scieces Center
state: Utah
city: Williamsburg
country: United States
facility: TPMG Clinical Research
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Chermside
country: Australia
facility: Lung Research QLD
state: Queensland
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Kent Town
country: Australia
facility: Respiratory Clinical Trials
state: South Australia
city: Nedlands
country: Australia
facility: Institute for Respiratory Health Sir Charles Gairdner Hospital
state: Western Australia
city: Spearwood
country: Australia
facility: TrialsWest
state: Western Australia
city: Louvain-la-Neuve
country: Belgium
facility: Cliniques Universitaires St-Luc
state: Wallon Region
city: Antwerp
country: Belgium
facility: UZ Antwerp
city: Brussels
country: Belgium
facility: CUB Hopital Erasme
city: Brussels
country: Belgium
facility: UZ Leuven- Campus Gasthuisberg
city: Namur
country: Belgium
facility: CHU UCL Namur site Godinne
city: Hamilton
country: Canada
facility: Firestone Institute for Respiratory Health
state: Ontario
city: Windsor
country: Canada
facility: Dr Anees Medicine Professional Corporation
state: Ontario
city: Windsor
country: Canada
facility: Dr Dhar Medical Practice
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hosp Research Inst
city: Bobigny
country: France
facility: Groupe Hospitalier Hopitaux Universitaires Paris-Seine-Saint-Denis-Hopital Avicenne
city: Lille
country: France
facility: CHRU Lille - Hopital Calmette
city: Marseille
country: France
facility: Hopital Nord de Marseille
city: Paris
country: France
facility: APHP - Hopital Europen Georges-Pompidou
city: Paris
country: France
facility: Hopital Bichat
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes Hopital Pontchaillou
city: Saint Pierre
country: France
facility: CHU de la Réunion Site SUD (Terre Sainte)
city: Saint-Pierre
country: France
facility: CHU de la Réunion- Site Félix Guyon
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasborg Service de Pneumologie Nouvel Hopital Civil
city: Tours
country: France
facility: Centre Hospitalier Rgional et Universitaire - Hopital Bretonneau
city: Tbilisi
country: Georgia
facility: Chapidze Emergency Cardiology Center
city: Tbilisi
country: Georgia
facility: The First Medical Center
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH
state: Baden-Württemberg
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen Department for Clinical Studies
state: Hessen
city: Warendorf
country: Germany
facility: ZMS Zentrum für medizinische Studien GmbH
state: Rhine-Westphalia
city: Delitzsch
country: Germany
facility: Klifeck GmbH Praxis Med. Gerald Eckhardt
state: Sachsen
city: Leipzig
country: Germany
facility: Studienzentrum Dr.med Falk Brunner FA fuer Innere Medizin und Pneumologie
state: Saxony
city: Bamberg
country: Germany
facility: CIMS Studienzentrum Bamberg GmbH
city: Donaustauf
country: Germany
facility: Krankenhaus Donaustauf
city: Essen
country: Germany
facility: Ruhrlandklinik Essen
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, P
city: Leipzig
country: Germany
facility: POIS Leipzig GbR
city: Munich
country: Germany
facility: Klinikum Grossadern der Ludwig-Maximilians-Universitaet Muenchen
city: Dublin
country: Ireland
facility: Trinity Centre for Health Sciences
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Kefar Sava
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Pulmonary Institute Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
city: Catania
country: Italy
facility: University-Hospital Policlinico Vittorio Emanuele
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: MIlan
country: Italy
facility: Ospedale San Giuseppe Clinica Malattie dell Apparato Respiratorio
city: Modena
country: Italy
facility: University Hospital of Mondena-AOU - Policlinico di Modena
city: Napoli
country: Italy
facility: A.O. Dei Colli OSPEDALE MONALDI
city: Padova
country: Italy
facility: Ospedale GB Morgagni
city: Palermo
country: Italy
facility: Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza, PO Molinette
city: Łódź
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
state: Lodz
city: Warszawa
country: Poland
facility: Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc
state: Mazovia
city: Kraków
country: Poland
facility: Oddział Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie
state: Małopolskie
city: Gdańsk
country: Poland
facility: Klinika Alergologii Pneumonologii
state: Pomerania
city: Poznań
country: Poland
facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
city: Chelyabinsk
country: Russian Federation
facility: Regional Clinical Hospital No. 3
city: Kazan
country: Russian Federation
facility: Kazan SMU, Republican Clinical Hospital of MOH, Republic of Tatarstan
city: Moscow
country: Russian Federation
facility: OLLA-MED
city: Moscow
country: Russian Federation
facility: Pulmonology Scientific Research Institute
city: Moscow
country: Russian Federation
facility: Evdokimov Moscow State University of Medicine and Dentistry
city: Saint Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
city: Yaroslavl
country: Russian Federation
facility: Soloviev Clinical Emergency Hospital
city: Yekaterinburg
country: Russian Federation
facility: LLC "Medical Association Novaya Bolnitsa"
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Santander
country: Spain
facility: Hospital Univ. Marques de Valdecilla
state: Cantabria
city: Lugo
country: Spain
facility: Hospital Universitario Lucas Augusti
state: Galicia
city: Pozuelo De Alarcón
country: Spain
facility: Hospital Universitario Quiron Madrid
state: Madrid
city: Barcelona
country: Spain
facility: Policlinica Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hopital de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Chernivtsi
country: Ukraine
facility: Chernivtsi Regional Clinical Hospital
city: Kyiv
country: Ukraine
facility: National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovsky
city: Kyiv
country: Ukraine
facility: National Research Centre for Radiation Medicine of The National Academy of Medical Sciences of UKR
city: Ternopil
country: Ukraine
facility: Ternopil Municipal City Hosipital 2
city: Vinnytsya
country: Ukraine
facility: Medical Centre Pulse
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
state: Cambridgeshire
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
state: Devon
city: London
country: United Kingdom
facility: Royal Brompton Hospital
state: Greater London
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
state: Greater Manchester
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hampshire
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
state: Leicestershire
city: Liverpool
country: United Kingdom
facility: Aintree Unversity Hospital NHS Foundation Trust
state: Merseyside
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle Royal Victoria Infirmary
state: Newcastle
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
state: Nottinghamshire
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital (RHH)
state: South Yorkshire
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
state: West Midlands
city: Bristol
country: United Kingdom
facility: Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
affiliation: Keck Medicine of USC
name: Toby Maher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.