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 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.

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

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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