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

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.

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Intervention / Treatment: Drug: GB0139; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • Lung Research Qld
  • South Australia
    • Adelaide, South Australia, Australia, 5042
      • Flinders Medical Centre
    • Kent Town, South Australia, Australia, 5067
      • Respiratory Clinical Trials
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Institute for Respiratory Health Sir Charles Gairdner Hospital
    • Spearwood, Western Australia, Australia, 6163
      • Trialswest
• Belgium
  • Antwerp, Belgium
    • UZ Antwerp
  • Brussels, Belgium, 1400
    • CUB Hôpital Erasme
  • Brussels, Belgium, 3000
    • UZ Leuven- Campus Gasthuisberg
  • Namur, Belgium, 5000
    • CHU UCL Namur Site Godinne
  • Wallon Region
    • Louvain-la-Neuve, Wallon Region, Belgium, 1348
      • Cliniques Universitaires St-Luc
• Canada
  • Toronto, Canada, M5T 2S8
    • Toronto General Hosp Research Inst
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Firestone Institute for Respiratory Health
    • Windsor, Ontario, Canada, N8X 1T3
      • Dr Anees Medicine Professional Corporation
    • Windsor, Ontario, Canada, N8X 5A6
      • Dr Dhar Medical Practice
• France
  • Bobigny, France, 93000
    • Groupe Hospitalier Hopitaux Universitaires Paris-Seine-Saint-Denis-Hopital Avicenne
  • Lille, France, 59000
    • CHRU Lille - Hopital Calmette
  • Marseille, France, 13015
    • Hôpital Nord de Marseille
  • Paris, France, 75877
    • Hôpital Bichat
  • Paris, France, 75015
    • APHP - Hopital Europen Georges-Pompidou
  • Rennes, France, 35033
    • Centre Hospitalier Universitaire de Rennes Hopital Pontchaillou
  • Saint Pierre, France, 97410
    • CHU de la Réunion Site SUD (Terre Sainte)
  • Saint-Pierre, France, 97410
    • CHU de la Réunion- Site Félix Guyon
  • Strasbourg, France, 67091
    • Hopitaux Universitaires de Strasborg Service de Pneumologie Nouvel Hopital Civil
  • Tours, France, 37044
    • Centre Hospitalier Rgional et Universitaire - Hopital Bretonneau
• Georgia
  • Tbilisi, Georgia, 0159
    • Chapidze Emergency Cardiology Center
  • Tbilisi, Georgia, 0180
    • The First Medical Center
• Germany
  • Bamberg, Germany, 96049
    • CIMS Studienzentrum Bamberg GmbH
  • Donaustauf, Germany, 93093
    • Krankenhaus Donaustauf
  • Essen, Germany, 45239
    • Ruhrlandklinik Essen
  • Leipzig, Germany, 04357
    • POIS Leipzig GbR
  • Leipzig, Germany, 04103
    • Universitaetsklinikum Leipzig Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, P
  • Munich, Germany, 81377
    • Klinikum Grossadern der Ludwig-Maximilians-Universitaet Muenchen
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69126
      • Thoraxklinik-Heidelberg gGmbH
  • Hessen
    • Immenhausen, Hessen, Germany, 34376
      • Lungenfachklinik Immenhausen Department for Clinical Studies
  • Rhine-Westphalia
    • Warendorf, Rhine-Westphalia, Germany, 48231
      • ZMS Zentrum für medizinische Studien GmbH
  • Sachsen
    • Delitzsch, Sachsen, Germany, 04509
      • Klifeck GmbH Praxis Med. Gerald Eckhardt
  • Saxony
    • Leipzig, Saxony, Germany, 04157
      • Studienzentrum Dr.med Falk Brunner FA fuer Innere Medizin und Pneumologie
• Ireland
  • Dublin, Ireland, D24NROA
    • Trinity Centre for Health Sciences
• Israel
  • Jerusalem, Israel
    • Hadassah Medical Center
  • Kefar Sava, Israel, 44281
    • Meir Medical Center
  • Petah Tikva, Israel, 4941492
    • Pulmonary Institute Rabin Medical Center
  • Ramat Gan, Israel
    • Sheba Medical Center
  • Reẖovot, Israel
    • Kaplan Medical Center
• Italy
  • Catania, Italy, 95123
    • University-Hospital Policlinico Vittorio Emanuele
  • MIlan, Italy, 20123
    • Ospedale San Giuseppe Clinica Malattie dell Apparato Respiratorio
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Modena, Italy, 41124
    • University Hospital of Mondena-AOU - Policlinico di Modena
  • Napoli, Italy, 80131
    • A.O. Dei Colli OSPEDALE MONALDI
  • Padova, Italy, 35100
    • Ospedale GB Morgagni
  • Palermo, Italy, 90127
    • Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
  • Siena, Italy, 53100
    • Azienda Ospedaliera Universitaria Senese
  • Turin, Italy, 10126
    • AOU Città della Salute e della Scienza, PO Molinette
• Poland
  • Poznań, Poland, 60-569
    • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
  • Lodz
    • Łódź, Lodz, Poland, 90-153
      • Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Mazovia
    • Warszawa, Mazovia, Poland, 01-138
      • Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc
  • Małopolskie
    • Kraków, Małopolskie, Poland, 30688
      • Oddział Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie
  • Pomerania
    • Gdańsk, Pomerania, Poland, 80-214
      • Klinika Alergologii Pneumonologii
• Russian Federation
  • Chelyabinsk, Russian Federation, 454021
    • Regional Clinical Hospital No. 3
  • Kazan, Russian Federation, 420064
    • Kazan SMU, Republican Clinical Hospital of MOH, Republic of Tatarstan
  • Moscow, Russian Federation, 105554
    • Olla-Med
  • Moscow, Russian Federation, 115682
    • Pulmonology Scientific Research Institute
  • Moscow, Russian Federation
    • Evdokimov Moscow State University of Medicine and Dentistry
  • Saint Petersburg, Russian Federation, 197022
    • Pavlov First Saint Petersburg State Medical University
  • Yaroslavl, Russian Federation, 150003
    • Soloviev Clinical Emergency Hospital
  • Yekaterinburg, Russian Federation, 620109
    • LLC "Medical Association Novaya Bolnitsa"
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 8035
    • Hospital Vall d'Hebron
  • Barcelona, Spain, 08006
    • Policlinica Barcelona
  • Barcelona, Spain, 08907
    • Hopital de Bellvitge
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Valencia, Spain, 46014
    • Hospital General de Valencia
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Univ. Marques de Valdecilla
  • Galicia
    • Lugo, Galicia, Spain, 27003
      • Hospital Universitario Lucas Augusti
  • Madrid
    • Pozuelo De Alarcón, Madrid, Spain, 28223
      • Hospital Universitario Quiron Madrid
• Ukraine
  • Chernivtsi, Ukraine, 58001
    • Chernivtsi Regional Clinical Hospital
  • Kyiv, Ukraine, 03038
    • National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovsky
  • Kyiv, Ukraine, 03115
    • National Research Centre for Radiation Medicine of The National Academy of Medical Sciences of UKR
  • Ternopil, Ukraine, 46023
    • Ternopil Municipal City Hosipital 2
  • Vinnytsya, Ukraine, 21001
    • Medical Centre Pulse
• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital
  • Edinburgh, United Kingdom, EH16 4SA
    • Royal Infirmary of Edinburgh
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
      • Papworth Hospital NHS Foundation Trust
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon and Exeter Hospital
  • Greater London
    • London, Greater London, United Kingdom, SW3 6NP
      • Royal Brompton Hospital
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M23 9LT
      • Wythenshawe Hospital
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • University Hospital Southampton NHS Foundation Trust
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE3 9QP
      • Glenfield Hospital
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L9 7AL
      • Aintree Unversity Hospital NHS Foundation Trust
  • Newcastle
    • Newcastle Upon Tyne, Newcastle, United Kingdom, NE1 4LP
      • Newcastle Royal Victoria Infirmary
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Nottingham City Hospital
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S5 7AU
      • Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital (RHH)
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B9 5SS
      • Birmingham Heartlands Hospital
• United States
  • Alabama
    • Andalusia, Alabama, United States, 36420-5310
      • SEC Clinical Research
    • Jasper, Alabama, United States, 35501
      • Jasper Summit Research, LLC Pulmonary & Sleep Associates
  • California
    • Palm Springs, California, United States, 92262-4871
      • Palmtree Clinical Research Inc
    • Redding, California, United States, 96001-0172
      • Paradigm Research
  • Connecticut
    • New Haven, Connecticut, United States, 06520-8057
      • Yale University School of Medicine
  • Florida
    • Gainesville, Florida, United States, 32611
      • Health Shands Hospital
    • Hialeah, Florida, United States, 33016
      • Harmony Medical Research Institute, Inc
    • Naples, Florida, United States, 34109
      • Advanced Research for Health Improvement
    • Pembroke Pines, Florida, United States, 33024
      • Broward Research Centre
    • Pensacola, Florida, United States, 32503
      • Avanza Medical Research Centre
    • Saint Petersburg, Florida, United States, 33704
      • Coastal Pulmonary Critical Care PLC
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital/Uni Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • The Emory Clinic
    • Atlanta, Georgia, United States, 30309
      • Piedmont Healthcare Pulmonary and Critical Care Research
    • Marietta, Georgia, United States, 30060-7297
      • DC Research Works
  • Illinois
    • Chicago, Illinois, United States, 97232
      • Northwestern Memorial Hospital
  • Indiana
    • Michigan City, Indiana, United States, 46360-9330
      • LaPorte County Institute for Clinical Research
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Centre
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard Medical School - Brigham and Womens Hospital (BWH)
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • The Lung Research Center LLC
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchcock Medical Center
  • North Carolina
    • Greensboro, North Carolina, United States, 27403
      • Pulmonlx LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45276
      • University of Cincinnati
    • Cleveland, Ohio, United States, 44109
      • The Cleveland Clinic Foundation
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Tennessee
    • Nashville, Tennessee, United States, 37232-2650
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Sciences Center at Houston
    • Houston, Texas, United States, 77030
      • University of Texas Health Centre at Houston
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Health Scieces Center
  • Virginia
    • Williamsburg, Virginia, United States, 23188
      • TPMG Clinical Research
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A. GB0139 3 mg once a day; Inhalation of GB0139	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.; Other Names: TD139
Placebo Comparator: B. Placebo once a day; Inhalation of Placebo	Drug: Placebo; Placebo is administered as inhalation once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Respiratory Related Hospitalizations	Number of Participants with Respiratory Related Hospitalizations from randomisation (including acute exacerbation of IPF).	52 weeks
Assessment of Respiratory Related Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)	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.	52 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute decline in FVC >5%	Percentage of subjects with an absolute decline from baseline in FVC (% predicted) of > 5%	52 weeks
6-minute walk test (6MWT) distance	Change from baseline in distance walked (metres) over 6 minutes	52 weeks
Diffusion capacity of the lung for carbon monoxide (DLCO)	Change from baseline in DLCO, corrected for Hemaglobin (mmol/min/kPa)	52 weeks
Assessment of Dyspnea using the University of California San Diego - Shortness of Breath Questionnaire (UCSD - SOBQ)	Change from baseline in UCSD - SOBQ Scored from 0-120 where a higher score indicates worse dyspnea	Weeks 12, 26 and 52
Assessment of Health Related Quality of Life (HRQoL) using the Short-Form 36-Item Health Survey (SF-36)	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	Weeks 12, 26 and 52
Frequency of Adverse Events (AE) or Serious Adverse Events (SAE)	Percentage of subjects with Adverse Events (AE) or Serious Adverse Events (SAE)	52 weeks
Time to hospitalization	Time in days to first hospitalization from all causes	52 weeks
Time to hospitalization	Time in days to first hospitalization (IPF related, including acute exacerbation of IPF)	52 weeks
Time to respiratory related death	Time in days to death from respiratory related causes (including IPF)	52 weeks
Time to initiation of pirfenidone or nintedanib treatment	Time in days to initiation of pirfenidone or nintedanib treatment in subjects not treated with pirfenidone or nintedanib at time of enrolment	52 weeks
Annual rate of decline in FVC in subjects never treated with pirfenidone or nintedanib	Change in FVC expressed in mL for subjects who have never been treated with pirfenidone or nintedanib	52 weeks

Collaborators and Investigators

• Sponsor: Galecto Biotech AB
• Collaborators: Syneos Health; bioRASI, LLC
• Investigators: Principal Investigator: Toby Maher, MD, PhD, Keck Medicine of USC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2019
• Primary Completion (Actual): May 17, 2023
• Study Completion (Actual): May 17, 2023

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: February 5, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Idiopathic pulmonary fibrosis; TD139; Galectin-3 inhibitor; GB0139
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: GALACTIC-1; 2018-002664-73 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No