Clinical study of the inhaled research drug GB0139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.

• Register: EUCTR
• Last refreshed on: 9 January 2023
• Main ID: EUCTR2018-002664-73-PL
• Date of registration: 14/03/2019
• Prospective Registration: Yes
• Primary sponsor: Galecto Biotech AB
• Public title: Clinical study of the inhaled research drug GB0139 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 GB0139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks
• Date of first enrolment: 09/07/2019
• Target sample size: 141
• 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: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Canada, France, Georgia, Germany, Ireland, Israel, Italy, Poland, Russian Federation, Spain, Ukraine, 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 five 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 (up to 12 months + 27 days) 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. Participants who currently are not being treated with nintedanib or pirfenidone; or cannot tolerate nintedanib or pirfenidone .
4. Participants must sign and date a written, IRB/EC approved 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 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 113

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, 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 nintedanib, pirfenidone, high dose corticosteroid, cytotoxic (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), vasodilator therapy for pulmonary hypertension (e.g. bosentan), Also see prohibited medications (Section 8.3). 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. Prior use of GB0139 or previously randomised in GALACTIC-1.
9. Prior use of nintedanib or pirfenidone within 7 days of initiation of screening.
10. Prior use of investigational drugs within 30 days (or 5 half-lives, whichever is longer) of initiation of screening.
11. Participating in another clinical trial, either interventional or observational.
12.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.
13.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.
14.Woman considered to be of childbearing potential who do not use highly effective birth control methods (A/B/C) during the study.
A. Highly effective methods of birth control (when used consistently and correctly) are:
o intrauterine device (IUD) placed at least 4 weeks prior to the IMP administration.
o bilateral tubal occlusion.
o Vasectomised partnerB.
o sexual abstinence
o combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal.
o progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable,
implantable.
o intrauterine hormone-releasing system (IUS).
B. Vasectomised partner is a highly effective birth control method provided that partner is
the sole sexual partner of the woman of childbearing potential trial subject and that the
vasectomised partner has received medical assessment of the surgical success.
C. Sexual abstinence is considered a highly effective method

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: GB0139 (previously known as TD139)
Product Code: GB0139 (previously known as TD139)
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: GB0139 (previously known as TD139)
Current Sponsor code: GB0139 (previously known as 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: Evaluate the effect of GB0139 dry powder for inhalation compared with placebo over 52 weeks treatment period on the annual rate of decline in FVC in participants with IPF who are not treated with or cannot tolerate nintedanib or pirfenidone.

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

Primary end point(s): the annual rate of decline in Forced Vital Capacity (FVC; expressed in mL over 52 weeks).

Secondary Objective: Further characterize the effect of GB0139 compared with placebo over 52 weeks treatment period on FVC, also on the quality of life, time to respiratory-related hospitalizations and all-cause mortality.

Secondary Outcome(s)

Secondary end point(s): •Proportion of subjects with an absolute decline from baseline in FVC (% pred) of >10% at w52.
•Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at w52.
•Time to first hospitalization (Irespiratory related, including acute exacerbation of IPF).
•Time to death (all-causes, respiratory).

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

Secondary ID(s)

2018-002664-73-IE

IND

GALACTIC-1

Source(s) of Monetary Support

Galecto Biotech AB

Ethics review

Status: Approved
Approval date: 12/03/2019
Contact: