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    Summary
    EudraCT Number:2018-002664-73
    Sponsor's Protocol Code Number:GALACTIC-1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-12
    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 ConcernedSpain - AEMPS
    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 - Estudio de fase IIb, aleatorizado, doble ciego, multicéntrico, con grupos paralelos, controlado con placebo en pacientes con fibrosis pulmonar idiopática (FPI) para investigar la eficacia y la seguridad de TD139, un inhibidor de la galectina-3 inhalado administrado mediante un inhalador de polvo seco durante 52 semanas
    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.
    Estudio clínico del fármaco en investigación inhalado TD139 para probar su efectividad y seguridad en pacientes con una enfermedad grave de cicatrización del pulmón durante 52 semanas.
    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 pointRichard Marshall
    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 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.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 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)
    pacientes con fibrosis pulmonar idiopática (FPI)
    E.1.1.1Medical condition in easily understood language
    serious scarring disease of the lung
    enfermedad grave de cicatrización del pulmón
    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 20.0
    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)
    Eficacia de TD139 evaluando la tasa anual de deterioro de la Capacidad Vital Forzada (CVF, expresada en ml a lo largo de 52 semanas)
    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 )
    • Proporción de pacientes con un deterioro absoluto en la semana 52 de >10 % respecto al inicio del porcentaje del valor predicho de CVF
    • Tiempo hasta la primera hospitalización (relacionada con la FPI incluidala exacerbación aguda de la FPI)
    • Tiempo hasta la muerte (por todas las causas, por causas respiratorias y/o provocadas por la FPI).
    • Las variables de eficacia secundarias y exploratorias adicionales con repercusión en la eficacia de TD139 (p. ej., la CdV) se describen detalladamente más adelante en los Principales criterios para evaluación y análisis
    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 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
    1. Pacientes, varones y mujeres, de ≥ 40 años de edad con un diagnóstico de FPI confirmado durante los tres años anteriores de acuerdo con los criterios ATS/ERS/Fleischner. Debe hallarse disponible una exploración diagnóstica por TCAR histórica, evaluada de acuerdo con los criterios ATS/ERS/Fleischner, de los 12 meses anteriores a la selección. Las TCAR diagnósticas se someterán a una lectura central para su confirmación.
    2. Parámetros de la función pulmonar con los siguientes valores:
    a. CVF >45 % del valor predicho en la selección
    b. DLCO (corregida para Hb) de entre el 30 % y el 79 % valor predicho en la selección.
    3. Antes de la aleatorización en el estudio, el IP/médico responsable deberá considerar que el TE (p. ej., pirfenidona o nintedanib en el grupo de TE1, pero excluyendo los medicamentos prohibidos) ha sido estable en cuanto a la pauta posológica y la tolerabilidad.
    4. Los pacientes deberán firmar y fechar un formulario de consentimiento informado escrito y cualquier autorización necesaria antes del inicio de los procedimientos del 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.
    No se podrá incluir en el estudio o asignar aleatoriamente tratamiento a los pacientes que cumplan cualquiera de los criterios de exclusión siguientes:
    1. Tener actualmente una obstrucción de las vías respiratorias significativa: cociente VEF1/CVF de <0,7 en la selección
    2. Presentar signos clínicos de infección activa, incluidas, entre otras, bronquitis, neumonía, sinusitis, infección del tracto urinario y celulitis.
    3. Tener antecedentes de neoplasia maligna en los últimos 2 años, a excepción del carcinoma basocelular, la leucemia linfocítica crónica (en observación) y el cáncer de próstata que requiera antiandrógenos, tratamiento localizado (cirugía menor, radioterapia) y/o manejo por observación.
    4. Tener alguna patología distinta de la FPI que, en opinión de investigador, podría provocar la muerte del paciente en los 2 años siguientes.
    5. La presencia de cualquier otra enfermedad que podría interferir en los procedimientos de las pruebas o que, a juicio del investigador, podría interferir en la participación en el ensayo o poner en riesgo al paciente al participar en este ensayo
    6. Tener posibilidades de recibir un trasplante de pulmón en los 12 meses siguientes.
    7. Estar recibiendo actualmente una dosis alta de corticoesteroides, citotóxicos (p. ej., clorambucilo, azatioprina, ciclofosfamida o metotrexato), un tratamiento vasodilatador para la hipertensión pulmonar (p. ej., bosentan) y/o un tratamiento en investigación para la FPI, o la administración de dichos tratamientos en el plazo de 4 semanas (o, si es más prolongado, en el de 5 semividas) anterior a la selección inicial. Ver también los medicamentos concomitantes excluidos (Sección 7.3). Se acepta una dosis actual igual o inferior a 15 mg/día de prednisona o equivalente si se prevé que la dosis va a permanecer estable durante el estudio.
    8. Tener antecedentes de enfermedad cardíaca o pulmonar inestable o degenerativa (distinta de la FPI) en los seis meses anteriores, incluidas, entre otras, las siguientes:
    a. Angina de pecho o infarto de miocardio inestable, o intervención coronaria percutánea en los últimos 6 meses
    b. Insuficiencia cardíaca congestiva que requiera hospitalización
    c. Arritmias clínicamente significativas no controladas.
    9. Si se trata de una paciente, estar embarazada o en período de lactancia, o tener previsto quedarse embarazada antes de la participación en este estudio, durante el estudio y después (5 vidas medias MAS 30 días) de la última dosis del medicamento del estudio; o con la intención de donar óvulos durante ese período de tiempo.
    10. Las mujeres a las que se considere potencialmente fértiles y que no utilicen métodos anticonceptivos altamente eficaces durante el 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)
    Eficacia de TD139 evaluando la tasa anual de deterioro de la Capacidad Vital Forzada (CVF, expresada en ml a lo largo de 52 semanas)
    E.5.1.1Timepoint(s) of evaluation of this end point
    • 52 weeks
    52 semanas
    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) .
    • Proporción de pacientes con un deterioro absoluto en la semana 52 de >10 % respecto al inicio del porcentaje del valor predicho de CVF
    • Tiempo hasta la primera hospitalización (relacionada con la FPI incluidala exacerbación aguda de la FPI)
    • Tiempo hasta la muerte (por todas las causas, por causas respiratorias y/o provocadas por la FPI).
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Week 52
    •Time to first hospitalization
    •Time to death
    . 52 semanas
    .Tiempo hasta la primera hospitalización
    .Tiempo hasta la muerte
    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 concerned70
    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 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
    Belgium
    Canada
    France
    Germany
    Ireland
    Israel
    Italy
    Poland
    Spain
    United Kingdom
    United States
    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
    ultima visita del ultimo paciente
    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 state35
    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.
    Una vez finalizado el ensayo clínico, los participantes serán tratados por el Investigador o médico del sujeto según el estado actual de las recomendaciones de la terapia.
    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 Decision2019-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-03
    P. End of Trial
    P.End of Trial StatusOngoing
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