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Idiopathic Pulmonary Fibrosis (IPF)Phase 2NCT03832946

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

A Phase 2 study testing GB0139 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Galecto Biotech AB at 128 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis (IPF)
What is being tested?
GB0139
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
172 participants
Where
128 sitesin 15 countries
Study dates
19 Feb 2019to 17 May 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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
  • 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.
  • Woman considered to be of childbearing potential who do not use highly effective birth control methods during the study.
  • Hypersensitivity to the active substance (TD139/GB0139) or the excipient (lactose).

Trial locations and contacts

128 sites in 15 countries.

128 sites in 15 countries

United States34 sites

  • SEC Clinical Research

    Andalusia, Alabama, 36420-5310

  • Piedmont Healthcare Pulmonary and Critical Care Research

    Atlanta, Georgia, 30309

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • University of Maryland

    Baltimore, Maryland, 21201

  • Harvard Medical School - Brigham and Womens Hospital (BWH)

    Boston, Massachusetts, 02115

  • The Lung Research Center LLC

    Chesterfield, Missouri, 63017

  • Northwestern Memorial Hospital

    Chicago, Illinois, 97232

  • University of Cincinnati

    Cincinnati, Ohio, 45276

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44109

  • Health Shands Hospital

    Gainesville, Florida, 32611

  • Pulmonlx LLC

    Greensboro, North Carolina, 27403

  • Harmony Medical Research Institute, Inc

    Hialeah, Florida, 33016

  • University of Texas Health Centre at Houston

    Houston, Texas, 77030

  • University of Texas Health Sciences Center at Houston

    Houston, Texas, 77030

  • Jasper Summit Research, LLC Pulmonary & Sleep Associates

    Jasper, Alabama, 35501

  • University of Kansas Medical Centre

    Kansas City, Kansas, 66160

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

  • DC Research Works

    Marietta, Georgia, 30060-7297

  • LaPorte County Institute for Clinical Research

    Michigan City, Indiana, 46360-9330

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Advanced Research for Health Improvement

    Naples, Florida, 34109

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-2650

  • Yale University School of Medicine

    New Haven, Connecticut, 06520-8057

  • Palmtree Clinical Research Inc

    Palm Springs, California, 92262-4871

  • Broward Research Centre

    Pembroke Pines, Florida, 33024

  • Avanza Medical Research Centre

    Pensacola, Florida, 32503

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Paradigm Research

    Redding, California, 96001-0172

  • University of Utah Health Scieces Center

    Salt Lake City, Utah, 84108

  • Diagnostics Research Group

    San Antonio, Texas, 78229

  • Coastal Pulmonary Critical Care PLC

    St. Petersburg, Florida, 33704

  • Tampa General Hospital/Uni Florida

    Tampa, Florida, 33606

  • TPMG Clinical Research

    Williamsburg, Virginia, 23188

Other trials in United States

United Kingdom13 sites

  • Birmingham Heartlands Hospital

    Birmingham, West Midlands, B9 5SS

  • Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital

    Bristol, BS10 5NB

  • Papworth Hospital NHS Foundation Trust

    Cambridge, Cambridgeshire, CB2 0AY

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA

  • Royal Devon and Exeter Hospital

    Exeter, Devon, EX2 5DW

  • Glenfield Hospital

    Leicester, Leicestershire, LE3 9QP

  • Aintree Unversity Hospital NHS Foundation Trust

    Liverpool, Merseyside, L9 7AL

  • Royal Brompton Hospital

    London, Greater London, SW3 6NP

  • Wythenshawe Hospital

    Manchester, Greater Manchester, M23 9LT

  • Newcastle Royal Victoria Infirmary

    Newcastle upon Tyne, Newcastle, NE1 4LP

  • Nottingham City Hospital

    Nottingham, Nottinghamshire, NG5 1PB

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

    Sheffield, South Yorkshire, S5 7AU

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

Germany11 sites

  • CIMS Studienzentrum Bamberg GmbH

    Bamberg, 96049

  • Klifeck GmbH Praxis Med. Gerald Eckhardt

    Delitzsch, Saxony, 04509

  • Krankenhaus Donaustauf

    Donaustauf, 93093

  • Ruhrlandklinik Essen

    Essen, 45239

  • Thoraxklinik-Heidelberg gGmbH

    Heidelberg, Baden-Wurttemberg, 69126

  • Lungenfachklinik Immenhausen Department for Clinical Studies

    Immenhausen, Hesse, 34376

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

    Leipzig, Saxony, 04157

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

    Leipzig, 04103

  • POIS Leipzig GbR

    Leipzig, 04357

  • Klinikum Grossadern der Ludwig-Maximilians-Universitaet Muenchen

    Munich, 81377

  • ZMS Zentrum für medizinische Studien GmbH

    Warendorf, Rhine-Westphalia, 48231

Other trials in Germany

Spain11 sites

  • Policlinica Barcelona

    Barcelona, 08006

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hopital de Bellvitge

    Barcelona, 08907

  • Hospital Vall d'Hebron

    Barcelona, 8035

  • Hospital Universitario Lucas Augusti

    Lugo, Galicia, 27003

  • Hospital Clinico San Carlos

    Madrid

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Quiron Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Univ. Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital General de Valencia

    Valencia, 46014

Other trials in Spain

France10 sites

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

    Bobigny, 93000

  • CHRU Lille - Hopital Calmette

    Lille, 59000

  • Hopital Nord de Marseille

    Marseille, 13015

  • APHP - Hopital Europen Georges-Pompidou

    Paris, 75015

  • Hopital Bichat

    Paris, 75877

  • Centre Hospitalier Universitaire de Rennes Hopital Pontchaillou

    Rennes, 35033

  • CHU de la Réunion Site SUD (Terre Sainte)

    Saint-Pierre, 97410

  • CHU de la Réunion- Site Félix Guyon

    Saint-Pierre, 97410

  • Hopitaux Universitaires de Strasborg Service de Pneumologie Nouvel Hopital Civil

    Strasbourg, 67091

  • Centre Hospitalier Rgional et Universitaire - Hopital Bretonneau

    Tours, 37044

Other trials in France

Italy9 sites

  • University-Hospital Policlinico Vittorio Emanuele

    Catania, 95123

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Ospedale San Giuseppe Clinica Malattie dell Apparato Respiratorio

    Milan, 20123

  • University Hospital of Mondena-AOU - Policlinico di Modena

    Modena, 41124

  • A.O. Dei Colli OSPEDALE MONALDI

    Naples, 80131

  • Ospedale GB Morgagni

    Padova, 35100

  • Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)

    Palermo, 90127

  • Azienda Ospedaliera Universitaria Senese

    Siena, 53100

  • AOU Città della Salute e della Scienza, PO Molinette

    Turin, 10126

Other trials in Italy

Russia8 sites

  • Regional Clinical Hospital No. 3

    Chelyabinsk, 454021

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

    Kazan', 420064

  • OLLA-MED

    Moscow, 105554

  • Pulmonology Scientific Research Institute

    Moscow, 115682

  • Evdokimov Moscow State University of Medicine and Dentistry

    Moscow

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, 197022

  • Soloviev Clinical Emergency Hospital

    Yaroslavl, 150003

  • LLC "Medical Association Novaya Bolnitsa"

    Yekaterinburg, 620109

Other trials in Russia

Australia5 sites

  • Flinders Medical Centre

    Adelaide, South Australia, 5042

  • Lung Research QLD

    Chermside, Queensland, 4032

  • Respiratory Clinical Trials

    Kent Town, South Australia, 5067

  • Institute for Respiratory Health Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • TrialsWest

    Spearwood, Western Australia, 6163

Other trials in Australia

Belgium5 sites

  • UZ Antwerp

    Antwerp

  • CUB Hopital Erasme

    Brussels, 1400

  • UZ Leuven- Campus Gasthuisberg

    Brussels, 3000

  • Cliniques Universitaires St-Luc

    Louvain-la-Neuve, Wallon Region, 1348

  • CHU UCL Namur site Godinne

    Namur, 5000

Other trials in Belgium

Israel5 sites

  • Hadassah Medical Center

    Jerusalem

  • Meir Medical Center

    Kefar Sava, 44281

  • Pulmonary Institute Rabin Medical Center

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan

  • Kaplan Medical Center

    Rehovot

Other trials in Israel

Poland5 sites

  • Klinika Alergologii Pneumonologii

    Gdansk, Pomeranian Voivodeship, 80-214

  • Oddział Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie

    Krakow, Lesser Poland Voivodeship, 30688

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

    Lodz, Łódź Voivodeship, 90-153

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

    Poznan, 60-569

  • Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc

    Warsaw, Masovian Voivodeship, 01-138

Other trials in Poland

Ukraine5 sites

  • Chernivtsi Regional Clinical Hospital

    Chernivtsi, 58001

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

    Kyiv, 03038

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

    Kyiv, 03115

  • Ternopil Municipal City Hosipital 2

    Ternopil, 46023

  • Medical Centre Pulse

    Vinnytsia, 21001

Other trials in Ukraine

Canada4 sites

  • Firestone Institute for Respiratory Health

    Hamilton, Ontario, L8N 4A6

  • Toronto General Hosp Research Inst

    Toronto, M5T 2S8

  • Dr Anees Medicine Professional Corporation

    Windsor, Ontario, N8X 1T3

  • Dr Dhar Medical Practice

    Windsor, Ontario, N8X 5A6

Other trials in Canada

Georgia2 sites

  • Chapidze Emergency Cardiology Center

    Tbilisi, 0159

  • The First Medical Center

    Tbilisi, 0180

Other trials in Georgia

Ireland1 site

  • Trinity Centre for Health Sciences

    Dublin, D24NROA

Other trials in Ireland

About this study

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.

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.

Read the 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.

Being tested
GB0139, Placebo
Keywords
TD139, Idiopathic pulmonary fibrosis, Galectin-3 inhibitor, GB0139
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GB0139Drug

    Also called TD139

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

  • PlaceboDrug

    Placebo is administered as inhalation once a day

Study groups in NCT03832946
Study groupRoleWhat they receive
A. GB0139 3 mg once a dayExperimentalInhalation of GB0139
Receives: Drug: GB0139
B. Placebo once a dayPlacebo comparatorInhalation of Placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 52 weeks

Secondary outcomes (2)

  1. Number of Participants With Respiratory Related Hospitalizations

    Number of Participants with Respiratory Related Hospitalizations from randomisation (including acute exacerbation of IPF).

    Measured: 52 weeks

  2. 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.

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2019
  2. Study start19 Feb 2019
  3. Primary completion17 May 2023
  4. Study completion17 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03832946
Sponsor's protocol ID
GALACTIC-1
Other IDs
2018-002664-73, 2018
Status last verified
Apr 2024
First submitted
4 Feb 2019
Last updated
22 May 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 35120836

  • 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.

    PubMed 33072090

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GB0139 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Galecto Biotech AB at 128 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in United States, United Kingdom, Germany, Spain, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annual Rate of Decline in Forced Vital Capacity (FVC) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03832946, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.

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