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    Summary
    EudraCT Number:2018-002664-73
    Sponsor's Protocol Code Number:GALACTIC-1
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-03-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-002664-73
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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.
    A.4.1Sponsor's protocol code numberGALACTIC-1
    A.5.4Other Identifiers
    Name:124075Number:IND
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGalecto Biotech AB
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGalecto Biotech AB
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalecto Biotech AB
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street AddressOle Maaloes Vej 3
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post codeDK-2200
    B.5.3.4CountryDenmark
    B.5.6E-mailgalactic-1@galecto.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/20/2309
    D.3 Description of the IMP
    D.3.1Product nameGB0139 (previously known as TD139)
    D.3.2Product code GB0139 (previously known as TD139)
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGB0139 (previously known as TD139)
    D.3.9.2Current sponsor codeGB0139 (previously known as TD139)
    D.3.9.3Other descriptive nameDEX284
    D.3.9.4EV Substance CodeSUB168582
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder, hard capsule
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with idiopathic pulmonary fibrosis (IPF)
    E.1.1.1Medical condition in easily understood language
    serious scarring disease of the lung
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10067761
    E.1.2Term Exacerbation of idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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 only if defined as refraining
    from heterosexual intercourse during the entire period of risk associated with the study
    treatments. The reliability of sexual abstinence needs to be evaluated in relation to the
    duration of the clinical trial.
    15.Hypersensitivity to the active substance (GB0139) or the excipient (lactose).
    E.5 End points
    E.5.1Primary end point(s)
    the annual rate of decline in Forced Vital Capacity (FVC; expressed in mL over 52 weeks).
    E.5.1.1Timepoint(s) of evaluation of this end point
    • 52 weeks
    E.5.2Secondary 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).
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Week 52
    •Time to first hospitalization
    •Time to death
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Israel
    United States
    France
    Poland
    Spain
    Germany
    Italy
    Belgium
    Georgia
    Ireland
    Russian Federation
    Ukraine
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 113
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 141
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After completion of the clinical trial, participants will be treated by the
    investigator or the subject's physician according to then-current state
    of the art therapy recommendations.

    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-05-17
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