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    Summary
    EudraCT Number:2018-002664-73
    Sponsor's Protocol Code Number:GALACTIC-1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-15
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    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 TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks
    GALACTIC-1 - Studio di Fase 2b randomizzato, in doppio cieco, multicentrico, parallelo, controllato verso placebo, sull’efficacia e sulla sicurezza di TD139, un inibitore della galectina-3 per inalazione, somministrato tramite inalatore di polvere secca in un periodo di 52 settimane, in soggetti con fibrosi polmonare idiopatica (IPF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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.
    Studio clinico del farmaco di ricerca per inalazione TD139 per testare la sua efficacia e sicurezza in pazienti con una malattia fibrosante del polmone grave in un periodo di 52 settimane.
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    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 point-
    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-mailRMarshall@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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTD139
    D.3.2Product code [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 INNTD139
    D.3.9.2Current sponsor codeTD139
    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 number5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 2
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTD139
    D.3.2Product code [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 INNTD139
    D.3.9.2Current sponsor codeTD139
    D.3.9.3Other descriptive nameDEX284
    D.3.9.4EV Substance CodeSUB168582
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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)
    pazienti affetti da fibrosi polmonare idiopatica (IPF)
    E.1.1.1Medical condition in easily understood language
    serious scarring disease of the lung
    malattia fibrosante del polmone grave
    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
    • Efficacy of TD139 by assessing the annual rate of decline in Forced Vital Capacity (FVC; expressed in mL over 52 weeks)
    • Efficacia di TD139 in base alla valutazione del tasso annuale di declino nella capacità vitale forzata (CVF; espressa in ml nell’arco di 52 settimane)
    E.2.2Secondary objectives of the trial
    • 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
    • Proporzione di soggetti con declino assoluto rispetto al basale nella CVF espressa come % del predetto >10% alla sett. 52
    • Tempo al primo ricovero (per IPF, compresa l’esacerbazione acuta dell’IPF)
    • Tempo al decesso (per tutte le cause, per cause respiratorie e/o dovuto all’IPF)
    Ulteriori variabili di efficacia secondarie ed esplorative connesse all’efficacia di TD139 (per es., qualità della vita [QoL]) sono descritte in modo dettagliato nei paragrafi Principali criteri e Valutazione ed analisi
    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 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 tollerability 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.
    1. Soggetti maschi e femmine di età =40 anni con diagnosi di IPF accertata durante i tre anni precedenti secondo i criteri ATS/ERS/Fleischner. I soggetti devono disporre di una scansione HRCT diagnostica storica valutata secondo i criteri ATS/ERS/Fleischner entro i 12 mesi precedenti lo screening. Le HRCT diagnostiche saranno sottoposte a lettura centrale a scopo di conferma.
    2. Parametri di funzionalità polmonare come indicato di seguito:
    a. CVF >45% del valore predetto allo screening;
    b. Capacità di diffusione polmonare del monossido di carbonio (DLCO) (corretta per l’emoglobina [Hb]) pari al 30%-79% del valore predetto allo screening.
    3. Prima della randomizzazione nello studio, qualsiasi attuale trattamento SoC (per es., pirfenidone o nintedanib nel gruppo SoC1, ma con l’esclusione dei farmaci vietati) deve essere giudicato stabile dal PI/medico curante in termini di regime di dosaggio e tollerabilità.
    4. I soggetti devono firmare e datare un modulo di consenso informato scritto e qualsiasi autorizzazione richiesta prima dell’avvio di qualsiasi procedura dello studio.
    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 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.
    Non dovranno essere arruolati nello studio/randomizzati al trattamento soggetti che soddisfino uno qualsiasi dei seguenti criteri di esclusione:
    1. Attuale ostruzione significativa delle vie aeree: rapporto volume espiratorio forzato in 1 secondo (FEV1)/CVF <0,7 allo screening.
    2. Evidenza clinica di infezione attiva, tra cui, in modo non limitativo, bronchite, polmonite, sinusite, infezione del tratto urinario e cellulite.
    3. Anamnesi di tumore maligno entro gli ultimi 2 anni, con l’eccezione del carcinoma basocellulare, della leucemia linfocitica cronica (sotto osservazione) e del tumore prostatico con necessità di terapia antiandrogenica, trattamento localizzato (chirurgia minore, radioterapia) e/o gestito mediante osservazione.
    4. Qualsiasi condizione diversa dall’IPF che, a giudizio dello sperimentatore, possa verosimilmente esitare nel decesso del soggetto entro i 2 anni successivi.
    5. Presenza di un’altra malattia che possa interferire con le procedure di analisi o che, a giudizio dello sperimentatore, possa interferire con la partecipazione alla sperimentazione o mettere a rischio il paziente durante la stessa.
    6. Soggetto che sarà verosimilmente sottoposto a trapianto polmonare entro i 12 mesi successivi.
    7. Attuale trattamento con corticosteroidi ad alta dose, farmaci citotossici (per es., clorambucile, azatioprina, ciclofosfamide, metotrexato), terapia vasodilatatoria per ipertensione polmonare (per es., bosentan) e/o terapia sperimentale per IPF; oppure somministrazione di tali terapie entro 4 settimane dallo screening iniziale (o 5 emivite, a seconda di quale sia il periodo più lungo). Vedere anche i farmaci concomitanti oggetto di esclusione (Sezione 7.3). Una dose attuale pari o inferiore a 15 mg/die di prednisone o suo equivalente è accettabile se si prevede che la dose rimarrà stabile durante lo studio.
    8. Anamnesi di malattia cardiaca o polmonare (diversa dall’IPF) instabile o in peggioramento nei sei mesi precedenti, tra cui, in modo non limitativo, le seguenti:
    a. angina pectoris instabile o infarto del miocardio, oppure intervento coronarico percutaneo negli ultimi 6 mesi;
    b. insufficienza cardiaca congestizia con necessità di ricovero;
    c. aritmie clinicamente significative non controllate.
    9. Se di sesso femminile, soggetto in stato di gravidanza o allattamento, o che abbia intenzione di avviare una gravidanza prima della partecipazione a questo studio, durante lo studio ed entro 5 emivite PIÙ 30 giorni dopo l’ultima dose del farmaco dello studio; oppure, che intenda donare ovociti durante tale periodo.
    10. Donne considerate in età fertile che non utilizzino metodi contraccettivi altamente efficaci durante lo studio.
    E.5 End points
    E.5.1Primary end point(s)
    • Efficacy of TD139 by assessing the annual rate of decline in Forced Vital Capacity (FVC; expressed in mL over 52 weeks)
    • Efficacia di TD139 in base alla valutazione del tasso annuale di declino nella capacità vitale forzata (CVF; espressa in ml nell’arco di 52 settimane)
    E.5.1.1Timepoint(s) of evaluation of this end point
    • 52 weeks
    • 52 settimane
    E.5.2Secondary 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).
    • Proporzione di soggetti con declino assoluto rispetto al basale nella CVF (% del predetto) >10% alla sett. 52.
    • Tempo al primo ricovero (per IPF, compresa l’esacerbazione acuta dell’IPF).
    • Tempo al decesso (per tutte le cause, per cause respiratorie e/o dovuto all’IPF).
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Week 52
    • Time to first hospitalization
    • Time to death
    • Settimana 52
    • Tempo al primo ricovero
    • Tempo al decesso
    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 trial3
    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 EEA70
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Israel
    United States
    Belgium
    France
    Germany
    Italy
    Poland
    Spain
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 360
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 276
    F.4.2.2In the whole clinical trial 450
    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.
    Dopo il completamento della sperimentazione clinica, i partecipanti saranno trattati dallo sperimentatore o dal medico del soggetto in accordo alle raccomandazioni di terapia stato dell'arte attuale in quel momento.
    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 Decision2019-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-15
    P. End of Trial
    P.End of Trial StatusOngoing
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