Clinical study of the inhaled research drug TD139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.

• Register: EUCTR
• Last refreshed on: 27 July 2020
• Main ID: EUCTR2018-002664-73-GB
• Date of registration: 22/01/2019
• Prospective Registration: Yes
• Primary sponsor: Galecto Biotech AB
• Public title: Clinical study of the inhaled research drug TD139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.
• Scientific title: GALACTIC-1- A randomized, double-blind, multicentre, 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
• Date of first enrolment: 24/09/2019
• Target sample size: 450
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-002664-73
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Canada, France, Germany, Ireland, Israel, Italy, Poland, Spain, United Kingdom, United States

Contacts

• Name: Chief Medical Officer
• Affiliation: Galecto Biotech AB

• Name: Chief Medical Officer
• Affiliation: Galecto Biotech AB

Key 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. A historical diagnostic HRCT scan assessed according to the ATS/ERS/Fleischner criteria must be available from within the 12 months prior to screening. Diagnostic HRCTs will be subject to central reading for confirmation.
2.Lung function parameters as follows:
a.FVC > 45% of the predicted value at screening
b.DLCO (corrected for Hb) of 30% to 79% of the predicted value at screening.
3.Any existing SoC treatment (e.g. pirfenidone or nintedanib in the SoC1 group but excluding prohibited medicines) must be deemed as stable in terms of dosing regimen, and tolerability by the PI/treating physician before randomization into the study.
4.Subjects must sign and date a written, informed consent form and any required authorization prior to initiation of any study procedures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 360

Exclusion criteria:
Subjects meeting any of the following exclusion criteria are not to be enrolled in the study/randomized to treatment:
1.Currently has significant airways obstruction: FEV1/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, squamous cell carcinoma of the skin (localised, treated or cured), 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 IPF or administration of such therapeutics within 4 weeks of initial screening (or 5 half-lives, whichever is longer). Also see excluded concomitant medicines (Section 7.3). 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:
a.Unstable angina pectoris or myocardial infarction, or percutaneous coronary intervention within the last 6 months
b.Congestive heart failure requiring hospitalization
c.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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

patients with idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0 Level: LLT Classification code 10067761 Term: Exacerbation of idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Name: TD139
Product Code: TD139
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: TD139
Current Sponsor code: TD139
Other descriptive name: DEX284
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Product Name: TD139
Product Code: TD139
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: TD139
Current Sponsor code: TD139
Other descriptive name: DEX284
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Main Objective: •Efficacy of TD139 by assessing the annual rate of decline in Forced Vital Capacity (FVC; expressed in mL over 52 weeks)

Primary end point(s): •Efficacy of TD139 by assessing the annual rate of decline in Forced Vital Capacity (FVC; expressed in mL over 52 weeks)

Secondary Objective: •Proportion of subjects with an absolute decline from baseline in FVC % pred of >10% at w52
•Time to first hospitalization (IPF related, including acute exacerbation of IPF) .
•Time to death (all-causes, respiratory-related causes and/or caused by IPF)
Additional secondary and exploratory efficacy variables with bearing on the efficacy of TD139 (e.g. QoL) are described in detail in the Main Criteria and Evaluation and Analyses )

Timepoint(s) of evaluation of this end point: • 52 weeks

Secondary Outcome(s)

Secondary end point(s): •Proportion of subjects with an absolute decline from baseline in FVC (% pred) of >10% at w52.
•Time to first hospitalization (IPF related, including acute exacerbation of IPF).
•Time to death (from all-causes, respiratory-related causes and/or caused by IPF) .

Timepoint(s) of evaluation of this end point: •Week 52
•Time to first hospitalization
•Time to death

Secondary ID(s)

2018-002664-73-IE

GALACTIC-1

IND

Source(s) of Monetary Support

Galecto Biotech AB

Ethics review

Status: Approved
Approval date: 24/09/2019
Contact: