A Study to Test the Efficacy and Safety of Inhaled TD139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Study Purpose

This is a randomized, double-blind, placebo-controlled phase 2b trial in subjects with IPF (idiopathic pulmonary fibrosis) investigating the efficacy and safety of TD139.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male and female subjects aged ≥ 40 years of age with a diagnosis of IPF established during the previous three 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. Any existing Standard of Care (SoC) treatment (e.g. pirfenidone or nintedanib) must be deemed as stable before randomization 4. Subjects must sign and date a written, 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 high dose corticosteroid, cytotoxic (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), vasodilator therapy for pulmonary hypertension (e.g., bosentan), and or investigational therapy for idiopathic pulmonary fibrosis (IPF) or administration of such therapeutics within 4 weeks of initial screening (or 5 half-lives, whichever is longer). 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. 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 9. 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. 10. Woman considered to be of childbearing potential who do not use highly effective birth control methods during the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03832946
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Galecto Biotech AB
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Toby Maher, MD, PhD
Principal Investigator Affiliation Imperial College London
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryOther
Overall Status Recruiting
Countries Belgium, Canada, France, Israel, Italy, Poland, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis (IPF)
Additional Details

This study is designed to evaluate the efficacy and safety of TD139, a galectin-3 inhibitor, administered by dry powder inhalation over 52 weeks. Subjects will continue on their existing standard of care (SoC), including pirfenidone or nintedanib. Two doses of TD139, each given once per day, will be compared to placebo. A follow up period of up to 52 weeks, where the subjects remain on their designated treatment, will provide valuable information on the longer-term safety of TD139 in IPF.

Arms & Interventions

Arms

Experimental: A. TD139 10 mg once a day

Inhalation of TD139

Experimental: B. TD139 3 mg once a day

Inhalation of TD139

Placebo Comparator: C. TD139 Placebo once a day

Inhalation of TD139 Placebo

Interventions

Drug: - TD139

TD139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.

Drug: - Placebo

Placebo is administered as inhalation once a day

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

SEC Clinical Research, Andalusia, Alabama

Status

Recruiting

Address

SEC Clinical Research

Andalusia, Alabama, 36420-5310

Site Contact

Robert Garver, MD

Clinicaltrials@galecto.com

+442037418183

Palmtree Clinical Research Inc, Palm Springs, California

Status

Recruiting

Address

Palmtree Clinical Research Inc

Palm Springs, California, 92262-4871

Site Contact

Ziad Tannous, MD

Clinicaltrials@galecto.com

+442037418183

Paradigm Research, Redding, California

Status

Recruiting

Address

Paradigm Research

Redding, California, 96001-0172

Site Contact

Rafael Lupercio, MD

Clinicaltrials@galecto.com

+442037418183

Yale University Scholl of Medicine, New Haven, Connecticut

Status

Recruiting

Address

Yale University Scholl of Medicine

New Haven, Connecticut, 06520-8057

Site Contact

Danielle Antin-Ozerkis, MD

Clinicaltrials@galecto.com

+442037418183

Harmony Medical Research Institute, Inc, Hialeah, Florida

Status

Recruiting

Address

Harmony Medical Research Institute, Inc

Hialeah, Florida, 33016

Site Contact

Juan Fernandez, MD

Clinicaltrials@galecto.com

+442037418183

Advanced Research for Health Improvement, Naples, Florida

Status

Recruiting

Address

Advanced Research for Health Improvement

Naples, Florida, 34109

Site Contact

Lisette Delgado Sanchez, MD

Clinicaltrials@galecto.com

+442037418183

Broward Research Center, Pembroke Pines, Florida

Status

Recruiting

Address

Broward Research Center

Pembroke Pines, Florida, 33024

Site Contact

Gustavo Echarte, MD

Clinicaltrials@galecto.com

+442037418183

Avanza Medical Research Center, Pensacola, Florida

Status

Recruiting

Address

Avanza Medical Research Center

Pensacola, Florida, 32503

Site Contact

Peter Bercz, MD

Clinicaltrials@galecto.com

+442037418183

Coastal Pulmonary Critical Care PLC, Saint Petersburg, Florida

Status

Recruiting

Address

Coastal Pulmonary Critical Care PLC

Saint Petersburg, Florida, 33704

Site Contact

Warren Abel, MD

Clinicaltrials@galecto.com

+442037418183

The Emory Clinic, Atlanta, Georgia

Status

Recruiting

Address

The Emory Clinic

Atlanta, Georgia, 30322

Site Contact

Srihari Veeraraghaven, MD

Clinicaltrials@galecto.com

+442037418183

DC Research Works, Marietta, Georgia

Status

Recruiting

Address

DC Research Works

Marietta, Georgia, 30060-7297

Site Contact

Binu George, MD

Clinicaltrials@galecto.com

+442037418183

Michigan City, Indiana

Status

Recruiting

Address

LaPorte County Institute for Clinical Research

Michigan City, Indiana, 46360-9330

Site Contact

Ikeadi Ndukwu, MD

Clinicaltrials@galecto.com

+442037418183

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Site Contact

Mark Hamblin, MD

Clinicaltrials@galecto.com

+442037418183

University of Louisville Hospital, Louisville, Kentucky

Status

Recruiting

Address

University of Louisville Hospital

Louisville, Kentucky, 40202

Site Contact

Sally Suliman, MD

Clinicaltrials@galecto.com

+442037418183

University of Maryland, Baltimore, Maryland

Status

Recruiting

Address

University of Maryland

Baltimore, Maryland, 21201

Site Contact

James Britt, MD

Clinicaltrials@galecto.com

+442037418183

The Lung Research Center LLC, Chesterfield, Missouri

Status

Recruiting

Address

The Lung Research Center LLC

Chesterfield, Missouri, 63017

Site Contact

Neil Ettinger, MD

Clinicaltrials@galecto.com

+442037418183

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766

Site Contact

Richard Enelow, MD

Clinicaltrials@galecto.com

+442037418183

Pulmonlx LLC, Greensboro, North Carolina

Status

Recruiting

Address

Pulmonlx LLC

Greensboro, North Carolina, 27403

Site Contact

Murali Ramaswamy, MD

Clinicaltrials@galecto.com

+442037418183

University of Cincinnati, Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati

Cincinnati, Ohio, 45276

Site Contact

Nishant Gupta, MD

Clinicaltrials@galecto.com

+442037418183

The Cleveland Clinic Foundation, Cleveland, Ohio

Status

Recruiting

Address

The Cleveland Clinic Foundation

Cleveland, Ohio, 44109

Site Contact

Aman Pande, MD

Clinicaltrials@galecto.com

+442037418183

Thomas Jefferson University, Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Site Contact

Jesse Roman, MD

Clinicaltrials@galecto.com

+442037418183

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2650

Site Contact

Lisa Lancaster, MD

Clinicaltrials@galecto.com

+442037418183

Houston, Texas

Status

Recruiting

Address

University of Texas Health Sciences Center at Houston

Houston, Texas, 77030

Site Contact

Namita Sood, MD

Clinicaltrials@galecto.com

+442037418183

University of Utah Health Scieces Center, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah Health Scieces Center

Salt Lake City, Utah, 84108

Site Contact

Mary Beth Scholand, MD

Clinicaltrials@galecto.com

+442037418183

International Sites

Cliniques Universitaires St-Luc, Louvain-la-Neuve, Wallon Region, Belgium

Status

Recruiting

Address

Cliniques Universitaires St-Luc

Louvain-la-Neuve, Wallon Region, 1348

Site Contact

Antonie Froidure, MD

Clinicaltrials@galecto.com

+442037418183

UZ Antwerp, Antwerp, Belgium

Status

Recruiting

Address

UZ Antwerp

Antwerp, ,

Site Contact

An-Sofie Verstraeten, MD

Clinicaltrials@galecto.com

+442037418183

CUB Hopital Erasme, Brussels, Belgium

Status

Recruiting

Address

CUB Hopital Erasme

Brussels, , 1400

Site Contact

Benjamin Bondue, MD

Clinicaltrials@galecto.com

+442037418183

UZ Leuven- Campus Gasthuisberg, Leuvan, Belgium

Status

Not yet recruiting

Address

UZ Leuven- Campus Gasthuisberg

Leuvan, , 3000

Site Contact

Wim Wuyts, MD

Clinicaltrials@galecto.com

+442037418183

Windsor, Ontario, Canada

Status

Recruiting

Address

Dr Anees Medicine Professional Corporation

Windsor, Ontario, N8X 1T3

Site Contact

Syed Anees, MD

Clinicaltrials@galecto.com

+442037418183

Dr Dhar Medical Practice, Windsor, Ontario, Canada

Status

Recruiting

Address

Dr Dhar Medical Practice

Windsor, Ontario, N8X 5A6

Site Contact

Anil Dhar, MD

Clinicaltrials@galecto.com

+442037418183

Bobigny, France

Status

Recruiting

Address

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

Bobigny, , 93000

Site Contact

Hilario Nunes, MD

Clinicaltrials@galecto.com

+442037418183

CHRU Lille - Hopital Calmette, Lille, France

Status

Recruiting

Address

CHRU Lille - Hopital Calmette

Lille, , 59000

Site Contact

Lidwine Wemeau, MD

Clinicaltrials@galecto.com

+442037418183

APHP - Hopital Europen Georges-Pompidou, Paris, France

Status

Recruiting

Address

APHP - Hopital Europen Georges-Pompidou

Paris, , 75015

Site Contact

Dominique Israel-Biet, MD

Clinicaltrials@galecto.com

+442037418183

Hopital Bichat, Paris, France

Status

Recruiting

Address

Hopital Bichat

Paris, , 75877

Site Contact

Bruno Crestani, MD

Clinicaltrials@galecto.com

+442037418183

Rennes, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Rennes Hopital Pontchaillou

Rennes, , 35033

Site Contact

Stephane Jouneau, MD

Clinicaltrials@galecto.com

+442037418183

Strasbourg, France

Status

Recruiting

Address

Hopitaux Universitaires de Strasborg Service de Pneumologie Nouvel Hopital Civil

Strasbourg, , 67091

Site Contact

Romain Kessler, MD

Clinicaltrials@galecto.com

+442037418183

Tours, France

Status

Recruiting

Address

Centre Hospitalier Rgional et Universitaire - Hopital Bretonneau

Tours, , 37044

Site Contact

Sylvain Marchand Adam, MD

Clinicaltrials@galecto.com

+442037418183

Hadassah Medical Center, Jerusalem, Israel

Status

Recruiting

Address

Hadassah Medical Center

Jerusalem, ,

Site Contact

Neville Berkman, MD

Clinicaltrials@galecto.com

+442037418183

Pulmonary Institute Rabin Medical Center, Petah Tikva, Israel

Status

Recruiting

Address

Pulmonary Institute Rabin Medical Center

Petah Tikva, , 4941492

Site Contact

Mordechai Kramer, MD

Clinicaltrials@galecto.com

+442037418183

Sheba Medical Center, Ramat Gan, Israel

Status

Recruiting

Address

Sheba Medical Center

Ramat Gan, ,

Site Contact

Michael Segel, MD

Clinicaltrials@galecto.com

+442037418183

Kaplan Medical Center, Reẖovot, Israel

Status

Recruiting

Address

Kaplan Medical Center

Reẖovot, ,

Site Contact

Gershon Fink, MD

Clinicaltrials@galecto.com

+442037418183

Catania, Italy

Status

Recruiting

Address

University-Hospital Policlinico Vittorio Emanuele

Catania, , 95123

Site Contact

Carlo Vancheri, MD

Clinicaltrials@galecto.com

+442037418183

Milan, Italy

Status

Recruiting

Address

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , 20122

Site Contact

Francesco Blasi, MD

Clinicaltrials@galecto.com

+442037418183

MIlan, Italy

Status

Recruiting

Address

Ospedale San Giuseppe Clinica Malattie dell Apparato Respiratorio

MIlan, , 20123

Site Contact

Sergio Harani, MD

Clinicaltrials@galecto.com

+442037418183

Modena, Italy

Status

Recruiting

Address

University Hospital of Mondena-AOU - Policlinico di Modena

Modena, , 41124

Site Contact

Stephania Cerri, MD

Clinicaltrials@galecto.com

+442037418183

A.O. Dei Colli OSPEDALE MONALDI, Napoli, Italy

Status

Recruiting

Address

A.O. Dei Colli OSPEDALE MONALDI

Napoli, , 80131

Site Contact

Marialuisa Bocchino, MD

Clinicaltrials@galecto.com

+442037418183

Azienda Ospedaliera Universitaria Senese, Siena, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Senese

Siena, , 53100

Site Contact

Elena Bargagli, MD

Clinicaltrials@galecto.com

+442037418183

Łódź, Lodz, Poland

Status

Recruiting

Address

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

Łódź, Lodz, 90-153

Site Contact

Wojciech Piotrowski, MD

Clinicaltrials@galecto.com

+442037418183

Warszawa, Mazovia, Poland

Status

Recruiting

Address

Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc

Warszawa, Mazovia, 01-138

Site Contact

Katarzyna Lewandowska, MD

Clinicaltrials@galecto.com

+442037418183

Kraków, Małopolskie, Poland

Status

Recruiting

Address

Oddział Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie

Kraków, Małopolskie, 30688

Site Contact

Krzysztof Sładek, MD

Clinicaltrials@galecto.com

+442037418183

Klinika Alergologii Pneumonologii, Gdańsk, Pomerania, Poland

Status

Recruiting

Address

Klinika Alergologii Pneumonologii

Gdańsk, Pomerania, 80-214

Site Contact

Alicja Sieminska, MD

Clinicaltrials@galecto.com

+442037418183

Poznań, Poland

Status

Recruiting

Address

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

Poznań, , 60-569

Site Contact

Halina Batura-Gabryel, MD

Clinicaltrials@galecto.com

+442037418183

Oviedo, Asturias, Spain

Status

Recruiting

Address

Hospital Universitario Central de Asturias

Oviedo, Asturias, 33011

Site Contact

Miguel Arias-Guillen, MD

Clinicaltrials@galecto.com

+442037418183

Hospital Universitario Quiron Madrid, Pozuelo De Alarcón, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Quiron Madrid

Pozuelo De Alarcón, Madrid, 28223

Site Contact

Jose Echave, MD

Clinicaltrials@galecto.com

+442037418183

Hospital Clinic de Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hospital Clinic de Barcelona

Barcelona, , 08036

Site Contact

Jacobo Sellares, MD

Clinicaltrials@galecto.com

+442037418183

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

Status

Recruiting

Address

Hospital de la Santa Creu i Sant Pau

Barcelona, , 08041

Site Contact

Diego Castillo Villagas, MD

Clinicaltrials@galecto.com

+442037418183

Hospital Vall d'Hebron, Barcelona, Spain

Status

Recruiting

Address

Hospital Vall d'Hebron

Barcelona, , 8035

Site Contact

Ana Villar, MD

Clinicaltrials@galecto.com

+442037418183

Hospital Clinico San Carlos, Madrid, Spain

Status

Recruiting

Address

Hospital Clinico San Carlos

Madrid, ,

Site Contact

Asuncion Nieto, MD

Clinicaltrials@galecto.com

+442037418183

Hospital General de Valencia, Valencia, Spain

Status

Recruiting

Address

Hospital General de Valencia

Valencia, , 46014

Site Contact

Estrella Fernandez Fabrellas, MD

Clinicaltrials@galecto.com

+442037418183

Royal Devon and Exeter Hospital, Exeter, Devon, United Kingdom

Status

Recruiting

Address

Royal Devon and Exeter Hospital

Exeter, Devon, EX2 5DW

Site Contact

Tom Burdem, MD

Clinicaltrials@galecto.com

+442037418183

Royal Brompton Hospital, London, Greater London, United Kingdom

Status

Recruiting

Address

Royal Brompton Hospital

London, Greater London, SW3 6NP

Site Contact

Philip Molyneaux, MD

Clinicaltrials@galecto.com

+442037418183

Wythenshawe Hospital, Manchester, Greater Manchester, United Kingdom

Status

Recruiting

Address

Wythenshawe Hospital

Manchester, Greater Manchester, M23 9LT

Site Contact

Nazia Chaudhuri, MD

Clinicaltrials@galecto.com

+442037418183

Southampton, Hampshire, United Kingdom

Status

Recruiting

Address

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD

Site Contact

Sophie Fletcher, MD

Clinicaltrials@galecto.com

+442037418183

Glenfield Hospital, Leicester, Leicestershire, United Kingdom

Status

Recruiting

Address

Glenfield Hospital

Leicester, Leicestershire, LE3 9QP

Site Contact

Bibek Gooptu, MD

Clinicaltrials@galecto.com

+442037418183

Liverpool, Merseyside, United Kingdom

Status

Recruiting

Address

Aintree Unversity Hospital NHS Foundation Trust

Liverpool, Merseyside, L9 7AL

Site Contact

Lisa Spencer, MD

Clinicaltrials@galecto.com

+442037418183

Newcastle Royal Victoria Infirmary, Newcastle Upon Tyne, Newcastle, United Kingdom

Status

Recruiting

Address

Newcastle Royal Victoria Infirmary

Newcastle Upon Tyne, Newcastle, NE1 4LP

Site Contact

Ian Forrest, MD

Clinicaltrials@galecto.com

+442037418183

Sheffield, South Yorkshire, United Kingdom

Status

Recruiting

Address

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

Sheffield, South Yorkshire, S5 7AU

Site Contact

Stephen Bianchi, MD

Clinicaltrials@galecto.com

+442037418183

Birmingham Heartlands Hospital, Birmingham, West Midlands, United Kingdom

Status

Recruiting

Address

Birmingham Heartlands Hospital

Birmingham, West Midlands, B9 5SS

Site Contact

Gareth Walters, MD

Clinicaltrials@galecto.com

+442037418183

Bristol, United Kingdom

Status

Recruiting

Address

Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital

Bristol, , BS10 5NB

Site Contact

Huzaifa Adamali, MD

Clinicaltrials@galecto.com

+442037418183

Royal Infirmary of Edinburgh, Edinburgh, United Kingdom

Status

Recruiting

Address

Royal Infirmary of Edinburgh

Edinburgh, , EH16 4SA

Site Contact

Nikhil Hirani, MD

Clinicaltrials@galecto.com

+442037418183

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