GALACTIC-1
-
StatusAccepting Candidates
-
Age40 Years - N/A
-
SexesAll
-
Healthy VolunteersNo
Objective
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.
Details
Full study title | GALACTIC-1 - A Randomized, Double-Blind, Multicenter, Parallel, Placebo-Controlled Phase 2b Study in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Investigating the Efficacy and Safety of TD139, an Inhaled Galectin-3 Inhibitor Administered via a Dry Powder Inhaler Over 52 Weeks |
Protocol number | OCR32102 |
ClinicalTrials.gov ID | NCT03832946 |
Phase | Phase 2 |
Eligibility
Inclusion Criteria:
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.
Exclusion Criteria:
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
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).
Lead researchers
-
Critical Care Medicine Specialist, Pulmonologist (Lung Specialist)
-
Divya C Patel, MDCritical Care Medicine Specialist, Pulmonologist (Lung Specialist)
Participate in a study
Here are some general steps to consider when participating in a research study:
-
Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
Christopher HardenDivya Patel -
Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
-
Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
-
Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.