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

NCT03832946 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: GALACTIC-12018-002664-73
• Study Type: interventional
• Target: 172
• Locations: 15 countries
• Sites: 128

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.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Keywords

TD139; Idiopathic pulmonary fibrosis; Galectin-3 inhibitor; GB0139

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Respiratory Related Hospitalizations

  52 weeks

• Assessment of Respiratory Related Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)

  52 weeks

Study Arms (2)

A. GB0139 3 mg once a day

EXPERIMENTAL

Inhalation of GB0139

Drug: GB0139

B. Placebo once a day

PLACEBO COMPARATOR

Inhalation of Placebo

Drug: Placebo

Interventions

GB0139 DRUG

GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.

Also known as: TD139

A. GB0139 3 mg once a day

Placebo DRUG

Placebo is administered as inhalation once a day

B. Placebo once a day

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Is likely to receive lung transplantation within the next 12 months.
• 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.
• Prior use of GB0139 (also called TD139) or previously randomized in GALACTIC-1.
• Prior use of nintedanib or pirfenidone within 7 days of initiation of screening.
• Prior use of investigational drugs within 30 days (or 5 half-lives, whichever is longer) of initiation of screening.
• Participating in another clinical trial, either interventional or observational.
• 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

Sponsors & Collaborators

• Galecto Biotech AB: lead
• Syneos Health: collaborator
• bioRASI, LLC: collaborator

Study Sites (128)

SEC Clinical Research

Andalusia, Alabama, 36420-5310, United States

Location

Jasper Summit Research, LLC Pulmonary & Sleep Associates

Jasper, Alabama, 35501, United States

Location

Palmtree Clinical Research Inc

Palm Springs, California, 92262-4871, United States

Location

Paradigm Research

Redding, California, 96001-0172, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520-8057, United States

Location

Health Shands Hospital

Gainesville, Florida, 32611, United States

Location

Harmony Medical Research Institute, Inc

Hialeah, Florida, 33016, United States

Location

Advanced Research for Health Improvement

Naples, Florida, 34109, United States

Location

Broward Research Centre

Pembroke Pines, Florida, 33024, United States

Location

Avanza Medical Research Centre

Pensacola, Florida, 32503, United States

Location

Coastal Pulmonary Critical Care PLC

St. Petersburg, Florida, 33704, United States

Location

Tampa General Hospital/Uni Florida

Tampa, Florida, 33606, United States

Location

Piedmont Healthcare Pulmonary and Critical Care Research

Atlanta, Georgia, 30309, United States

Location

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

DC Research Works

Marietta, Georgia, 30060-7297, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 97232, United States

Location

LaPorte County Institute for Clinical Research

Michigan City, Indiana, 46360-9330, United States

Location

University of Kansas Medical Centre

Kansas City, Kansas, 66160, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Harvard Medical School - Brigham and Womens Hospital (BWH)

Boston, Massachusetts, 02115, United States

Location

The Lung Research Center LLC

Chesterfield, Missouri, 63017, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Pulmonlx LLC

Greensboro, North Carolina, 27403, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45276, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44109, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2650, United States

Location

University of Texas Health Centre at Houston

Houston, Texas, 77030, United States

Location

University of Texas Health Sciences Center at Houston

Houston, Texas, 77030, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

University of Utah Health Scieces Center

Salt Lake City, Utah, 84108, United States

Location

TPMG Clinical Research

Williamsburg, Virginia, 23188, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Lung Research QLD

Chermside, Queensland, 4032, Australia

Location

Flinders Medical Centre

Adelaide, South Australia, 5042, Australia

Location

Respiratory Clinical Trials

Kent Town, South Australia, 5067, Australia

Location

Institute for Respiratory Health Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

TrialsWest

Spearwood, Western Australia, 6163, Australia

Location

Cliniques Universitaires St-Luc

Louvain-la-Neuve, Wallon Region, 1348, Belgium

Location

UZ Antwerp

Antwerp, Belgium

Location

CUB Hopital Erasme

Brussels, 1400, Belgium

Location

UZ Leuven- Campus Gasthuisberg

Brussels, 3000, Belgium

Location

CHU UCL Namur site Godinne

Namur, 5000, Belgium

Location

Firestone Institute for Respiratory Health

Hamilton, Ontario, L8N 4A6, Canada

Location

Dr Anees Medicine Professional Corporation

Windsor, Ontario, N8X 1T3, Canada

Location

Dr Dhar Medical Practice

Windsor, Ontario, N8X 5A6, Canada

Location

Toronto General Hosp Research Inst

Toronto, M5T 2S8, Canada

Location

Groupe Hospitalier Hopitaux Universitaires Paris-Seine-Saint-Denis-Hopital Avicenne

Bobigny, 93000, France

Location

CHRU Lille - Hopital Calmette

Lille, 59000, France

Location

Hopital Nord de Marseille

Marseille, 13015, France

Location

APHP - Hopital Europen Georges-Pompidou

Paris, 75015, France

Location

Hopital Bichat

Paris, 75877, France

Location

Centre Hospitalier Universitaire de Rennes Hopital Pontchaillou

Rennes, 35033, France

Location

CHU de la Réunion Site SUD (Terre Sainte)

Saint-Pierre, 97410, France

Location

CHU de la Réunion- Site Félix Guyon

Saint-Pierre, 97410, France

Location

Hopitaux Universitaires de Strasborg Service de Pneumologie Nouvel Hopital Civil

Strasbourg, 67091, France

Location

Centre Hospitalier Rgional et Universitaire - Hopital Bretonneau

Tours, 37044, France

Location

Chapidze Emergency Cardiology Center

Tbilisi, 0159, Georgia

Location

The First Medical Center

Tbilisi, 0180, Georgia

Location

Thoraxklinik-Heidelberg gGmbH

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Lungenfachklinik Immenhausen Department for Clinical Studies

Immenhausen, Hesse, 34376, Germany

Location

ZMS Zentrum für medizinische Studien GmbH

Warendorf, Rhine-Westphalia, 48231, Germany

Location

Klifeck GmbH Praxis Med. Gerald Eckhardt

Delitzsch, Saxony, 04509, Germany

Location

Studienzentrum Dr.med Falk Brunner FA fuer Innere Medizin und Pneumologie

Leipzig, Saxony, 04157, Germany

Location

CIMS Studienzentrum Bamberg GmbH

Bamberg, 96049, Germany

Location

Krankenhaus Donaustauf

Donaustauf, 93093, Germany

Location

Ruhrlandklinik Essen

Essen, 45239, Germany

Location

Universitaetsklinikum Leipzig Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, P

Leipzig, 04103, Germany

Location

POIS Leipzig GbR

Leipzig, 04357, Germany

Location

Klinikum Grossadern der Ludwig-Maximilians-Universitaet Muenchen

Munich, 81377, Germany

Location

Trinity Centre for Health Sciences

Dublin, D24NROA, Ireland

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Meir Medical Center

Kefar Sava, 44281, Israel

Location

Pulmonary Institute Rabin Medical Center

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Kaplan Medical Center

Rehovot, Israel

Location

University-Hospital Policlinico Vittorio Emanuele

Catania, 95123, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Ospedale San Giuseppe Clinica Malattie dell Apparato Respiratorio

Milan, 20123, Italy

Location

University Hospital of Mondena-AOU - Policlinico di Modena

Modena, 41124, Italy

Location

A.O. Dei Colli OSPEDALE MONALDI

Napoli, 80131, Italy

Location

Ospedale GB Morgagni

Padua, 35100, Italy

Location

Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)

Palermo, 90127, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

AOU Città della Salute e della Scienza, PO Molinette

Turin, 10126, Italy

Location

Oddział Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie

Krakow, Lesser Poland Voivodeship, 30688, Poland

Location

Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc

Warsaw, Masovian Voivodeship, 01-138, Poland

Location

Klinika Alergologii Pneumonologii

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

Poznan, 60-569, Poland

Location

Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

Lodz, Łódź Voivodeship, 90-153, Poland

Location

Regional Clinical Hospital No. 3

Chelyabinsk, 454021, Russia

Location

Kazan SMU, Republican Clinical Hospital of MOH, Republic of Tatarstan

Kazan', 420064, Russia

Location

OLLA-MED

Moscow, 105554, Russia

Location

Pulmonology Scientific Research Institute

Moscow, 115682, Russia

Location

Evdokimov Moscow State University of Medicine and Dentistry

Moscow, Russia

Location

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, 197022, Russia

Location

Soloviev Clinical Emergency Hospital

Yaroslavl, 150003, Russia

Location

LLC "Medical Association Novaya Bolnitsa"

Yekaterinburg, 620109, Russia

Location

Hospital Univ. Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Lucas Augusti

Lugo, Galicia, 27003, Spain

Location

Hospital Universitario Quiron Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Policlinica Barcelona

Barcelona, 08006, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hopital de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Vall d'Hebron

Barcelona, 8035, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital General de Valencia

Valencia, 46014, Spain

Location

Chernivtsi Regional Clinical Hospital

Chernivtsi, 58001, Ukraine

Location

National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovsky

Kyiv, 03038, Ukraine

Location

National Research Centre for Radiation Medicine of The National Academy of Medical Sciences of UKR

Kyiv, 03115, Ukraine

Location

Ternopil Municipal City Hosipital 2

Ternopil, 46023, Ukraine

Location

Medical Centre Pulse

Vinnytsia, 21001, Ukraine

Location

Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, Devon, EX2 5DW, United Kingdom

Location

Royal Brompton Hospital

London, Greater London, SW3 6NP, United Kingdom

Location

Wythenshawe Hospital

Manchester, Greater Manchester, M23 9LT, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Glenfield Hospital

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Aintree Unversity Hospital NHS Foundation Trust

Liverpool, Merseyside, L9 7AL, United Kingdom

Location

Newcastle Royal Victoria Infirmary

Newcastle upon Tyne, Newcastle, NE1 4LP, United Kingdom

Location

Nottingham City Hospital

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital (RHH)

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, West Midlands, B9 5SS, United Kingdom

Location

Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 35120836 DERIVED

• 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.

  PMID: 33072090 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

GB-0139

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Hans Schambye - Chief Executive Officer
• Organization: Galecto Biotech aps

info@galecto.com

+4526373726

Study Officials

• Toby Maher, MD, PhD

  Keck Medicine of USC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is a double-blind study. The blinding will be maintained throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 6, 2019
• Study Start: February 19, 2019
• Primary Completion: May 17, 2023
• Study Completion: May 17, 2023
• Last Updated: May 22, 2024
• Results First Posted: May 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (11); AU (5); GE (2); IL (5); IE (1); IT (9); US (34); PL (5); GB (13); FR (10); CA (4); RU (8); UA (5); ES (11); BE (5)