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

Idiopathic Pulmonary Fibrosis (IPF) Clinical Trial

Official title:

GALACTIC-1 -A Randomized, 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 Administered Via a Dry Powder Inhaler Over 52 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832946
• Other study ID #: GALACTIC-1
• Secondary ID: 2018-002664-73
• Status: Completed
• Phase: Phase 2
• Start date: February 19, 2019
• Est. completion date: May 17, 2023

Study information

• Verified date: May 2023
• Source: Galecto Biotech AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: May 17, 2023
• Est. primary completion date: May 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Idiopathic Pulmonary Fibrosis (IPF)
• Pulmonary Fibrosis

Intervention

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.
• Placebo
Placebo is administered as inhalation once a day

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Adelaide	South Australia
Australia	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	TrialsWest	Spearwood	Western Australia
Belgium	UZ Antwerp	Antwerp
Belgium	CUB Hopital Erasme	Brussels
Belgium	UZ Leuven- Campus Gasthuisberg	Brussels
Belgium	Cliniques Universitaires St-Luc	Louvain-la-Neuve	Wallon Region
Belgium	CHU UCL Namur site Godinne	Namur
Canada	Firestone Institute for Respiratory Health	Hamilton	Ontario
Canada	Toronto General Hosp Research Inst	Toronto
Canada	Dr Anees Medicine Professional Corporation	Windsor	Ontario
Canada	Dr Dhar Medical Practice	Windsor	Ontario
France	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
Georgia	Chapidze Emergency Cardiology Center	Tbilisi
Georgia	The First Medical Center	Tbilisi
Germany	CIMS Studienzentrum Bamberg GmbH	Bamberg
Germany	Klifeck GmbH Praxis Med. Gerald Eckhardt	Delitzsch	Sachsen
Germany	Krankenhaus Donaustauf	Donaustauf
Germany	Ruhrlandklinik Essen	Essen
Germany	Thoraxklinik-Heidelberg gGmbH	Heidelberg	Baden-Württemberg
Germany	Lungenfachklinik Immenhausen Department for Clinical Studies	Immenhausen	Hessen
Germany	POIS Leipzig GbR	Leipzig
Germany	Studienzentrum Dr.med Falk Brunner FA fuer Innere Medizin und Pneumologie	Leipzig	Saxony
Germany	Universitaetsklinikum Leipzig Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, P	Leipzig
Germany	Klinikum Grossadern der Ludwig-Maximilians-Universitaet Muenchen	Munich
Germany	ZMS Zentrum für medizinische Studien GmbH	Warendorf	Rhine-Westphalia
Ireland	Trinity Centre for Health Sciences	Dublin
Israel	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	Re?ovot
Italy	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	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
Poland	Klinika Alergologii Pneumonologii	Gdansk	Pomerania
Poland	Oddzial Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie	Kraków	Malopolskie
Poland	Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi	Lódz	Lodz
Poland	Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu	Poznan
Poland	Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc	Warszawa	Mazovia
Spain	Hopital de Bellvitge	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Policlinica Barcelona	Barcelona
Spain	Hospital Universitario Lucas Augusti	Lugo	Galicia
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Universitario Quiron Madrid	Pozuelo De Alarcón	Madrid
Spain	Hospital Univ. Marques de Valdecilla	Santander	Cantabria
Spain	Hospital General de Valencia	Valencia
Ukraine	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	Vinnytsya
United Kingdom	Birmingham Heartlands Hospital	Birmingham	West Midlands
United Kingdom	Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital	Bristol
United Kingdom	Papworth Hospital NHS Foundation Trust	Cambridge	Cambridgeshire
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Royal Devon and Exeter Hospital	Exeter	Devon
United Kingdom	Glenfield Hospital	Leicester	Leicestershire
United Kingdom	Aintree Unversity Hospital NHS Foundation Trust	Liverpool	Merseyside
United Kingdom	Royal Brompton Hospital	London	Greater London
United Kingdom	Wythenshawe Hospital	Manchester	Greater Manchester
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	University Hospital Southampton NHS Foundation Trust	Southampton	Hampshire
United States	SEC Clinical Research	Andalusia	Alabama
United States	Piedmont Healthcare Pulmonary and Critical Care Research	Atlanta	Georgia
United States	The Emory Clinic	Atlanta	Georgia
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	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Health Shands Hospital	Gainesville	Florida
United States	Pulmonlx LLC	Greensboro	North Carolina
United States	Harmony Medical Research Institute, Inc	Hialeah	Florida
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	Jasper Summit Research, LLC Pulmonary & Sleep Associates	Jasper	Alabama
United States	University of Kansas Medical Centre	Kansas City	Kansas
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Louisville Hospital	Louisville	Kentucky
United States	DC Research Works	Marietta	Georgia
United States	LaPorte County Institute for Clinical Research	Michigan City	Indiana
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Advanced Research for Health Improvement	Naples	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Palmtree Clinical Research Inc	Palm Springs	California
United States	Broward Research Centre	Pembroke Pines	Florida
United States	Avanza Medical Research Centre	Pensacola	Florida
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Paradigm Research	Redding	California
United States	Coastal Pulmonary Critical Care PLC	Saint Petersburg	Florida
United States	University of Utah Health Scieces Center	Salt Lake City	Utah
United States	Diagnostics Research Group	San Antonio	Texas
United States	Tampa General Hospital/Uni Florida	Tampa	Florida
United States	TPMG Clinical Research	Williamsburg	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Galecto Biotech AB	bioRASI, LLC, Syneos Health

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Georgia,  Germany,  Ireland,  Israel,  Italy,  Poland,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Absolute decline in FVC >5%	Percentage of subjects with an absolute decline from baseline in FVC (% predicted) of > 5%	52 weeks
Other	6-minute walk test (6MWT) distance	Change from baseline in distance walked (metres) over 6 minutes	52 weeks
Other	Diffusion capacity of the lung for carbon monoxide (DLCO)	Change from baseline in DLCO, corrected for Hemaglobin (mmol/min/kPa)	52 weeks
Other	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
Other	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
Other	Frequency of Adverse Events (AE) or Serious Adverse Events (SAE)	Percentage of subjects with Adverse Events (AE) or Serious Adverse Events (SAE)	52 weeks
Other	Time to hospitalization	Time in days to first hospitalization from all causes	52 weeks
Other	Time to hospitalization	Time in days to first hospitalization (IPF related, including acute exacerbation of IPF)	52 weeks
Other	Time to respiratory related death	Time in days to death from respiratory related causes (including IPF)	52 weeks
Other	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
Other	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
Primary	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	Absolute decline in FVC >10%	Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of > 10%	52 weeks
Secondary	Time to first hospitalization	Time to first hospitalization (respiratory related, including acute exacerbation of IPF) expressed in days.	52 weeks
Secondary	Time to death	Time to death from all-causes, respiratory-related causes and/or caused by IPF expressed in days	52 weeks
Secondary	Assessment of Respiratory Related Quality of Life using the St. George's Respiratory Questionnaire (SGRQ)	Change from baseline 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