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    Summary
    EudraCT Number:2017-002533-32
    Sponsor's Protocol Code Number:INS1007-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-002533-32
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study.
    Estudio Aleatorizado, Doble Ciego, Controlado con Placebo, De Grupos Paralelos, Multicéntrico, para Evaluar la Eficacia, la Seguridad, la Tolerabilidad y la Farmacocinética de INS1007 Administrada Una Vez al Día Durante 24 Semanas en Sujetos con Bronquiectasia No Debida a Fibrosis Quística; El Estudio Willow.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.
    Un estudio para evaluar la eficacia y la seguridad de la medicación del estudio INS1007 administrada una vez al día en pacientes con bronquiectasia no debida a fibrosis quística.
    A.4.1Sponsor's protocol code numberINS1007-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03218917
    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 SponsorInsmed Incorporated
    B.1.3.4CountryUnited States
    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 supportInsmed Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInsmed Incorporated
    B.5.2Functional name of contact pointClinical trial contact
    B.5.3 Address:
    B.5.3.1Street Address10 Finderne Avenue, Building 10
    B.5.3.2Town/ cityBridgewater, NJ 08807 3365
    B.5.3.3Post codeNJ 08807 3365
    B.5.3.4CountryUnited States
    B.5.4Telephone number41795432860
    B.5.5Fax number1908325 0386
    B.5.6E-mailtom.vanthienen@insmed.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 nameINS1007
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available
    D.3.9.1CAS number not availabl
    D.3.9.2Current sponsor codeINS1007
    D.3.9.3Other descriptive nameAZD7986
    D.3.9.4EV Substance CodeSUB188281
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 No
    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 nameINS1007
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available
    D.3.9.1CAS number no available
    D.3.9.2Current sponsor codeINS1007
    D.3.9.3Other descriptive nameAZD7986
    D.3.9.4EV Substance CodeSUB188281
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-Cystic Fibrosis Bronchiectasis
    Bronquiectasia no debida a fibrosis quística
    E.1.1.1Medical condition in easily understood language
    Non-Cystic Fibrosis Bronchiectasis
    Bronquiectasia no debida a fibrosis quística
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of INS1007 compared with placebo on time to first pulmonary exacerbation over the 24-week treatment period.
    To assess the safety and tolerability of INS1007 relative to placebo based on adverse events (AEs), vital signs and electrocardiogram (ECG) measurements, physical exams and clinical laboratory evaluations.
    Evaluar el efecto del INS1007 comparado con placebo sobre el tiempo hasta la primera exacerbación pulmonar a lo largo del periodo de tratamiento de 24 semanas.
    Evaluar la seguridad y tolerabilidad de INS1007 comparadas con placebo, basándose en los acontecimientos adversos (AA), las constantes vitales y las medidas del electrocardiograma (ECG), exploraciones físicas y exámenes de laboratorio clínico.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of INS1007 compared with placebo on quality of life (QOL), as assessed by the Quality of Life Questionnaire-Bronchiectasis (QOL-B), Respiratory Symptoms Domain score, over the 24-week treatment period.
    2. To evaluate the effect of INS1007 compared with placebo on lung function, as measured by forced expiratory volume in 1 second (FEV1), over the 24-week treatment period.
    3. To evaluate the effect of INS1007 compared with placebo on the concentration of active neutrophil elastase (NE) in sputum, as measured by the difference between the pre-treatment concentration (defined as the average of the values at Screening and Day 1) and on-treatment concentration (defined as the average of the values at weeks 12 and 24).
    4. To evaluate the effect of INS1007 compared with placebo on the rate of pulmonary exacerbations over the 24-week treatment period.
    1. Evaluar el efecto del INS1007 comparado con placebo sobre la calidad de vida (CdV) según evaluación mediante el Cuestionario sobre calidad de vida-Bronquiectasia (QOL-B), escala del dominio de síntomas respiratorios, a lo largo del periodo de tratamiento de 24 semanas.
    2. Evaluar el efecto de INS1007 comparado con placebo sobre la función pulmonar, medida mediante volumen espiratorio forzado en 1 segundo (VEF1) a lo largo del periodo de tratamiento de 24 semanas.
    3. Evaluar el efecto de INS1007 comparado con placebo en la concentración de elastasa de neutrófilos (EN) activa en el esputo, medida según la diferencia entre la concentración pretratamiento (definida como la media de valores de los días de la selección y el día 1) y la concentración con tratamiento (definida como la media de los valores la semanas 12 y 24).
    4. Evaluar el efecto de INS1007 comparado con placebo en la tasa de exacerbaciones pulmonares a lo largo del periodo de tratamiento de 24 semanas.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A PK sub-study will be conducted at a selected number of sites globally. Subjects who enroll at the selected sites will undergo intensive PK sampling. A maximum of 36 subjects will be included in the PK sub-study. For subjects who participate in the PK sub-study, the visit window for Visit 4 will be ± 5 days.

    Pharmacokinetic Objectives:
    1. To evaluate the pharmacokinetics (PK) of INS1007.
    2. To assess the relationship between PK measures for INS1007 and efficacy, safety and biomarker measures (e.g., concentrations of active NE in sputum and reagent-stimulated blood).
    Se llevará a cabo un subestudio FC en un cierto número de centros a nivel global. Los sujetos que se inscriban en los centros seleccionados (ningún centro en España) se someterán a un muestreo intensivo para FC. Se incluirá un máximo de 36 sujetos en el subestudio FC. Para los sujetos que participen en el subestudio FC, el margen de días de visita para la visita 4 será de ± 5 días.

    Objetivos de Farmacocinética:
    1. Evaluar la farmacocinética (FC) de INS1007.
    2. Evaluar la relación entre las medidas FC para INS1007 y las medidas de eficacia, seguridad y biomarcadores (p.ej., concentraciones de EN activa en esputo y sangre estimulada con reactivos).
    E.3Principal inclusion criteria
    Subjects who have given their signed, informed consent, are male or female between 18 and 85 years of age (inclusive) with a body mass index > 18.5 at Screening (Visit 1) and have a clinical history consistent with NCFBE will be eligible for enrollment in the study.
    Los sujetos que hayan proporcionado su consentimiento informado firmado, sean varones o mujeres de entre 18 y 85 años de edad (inclusive) con un índice de masa corporal > 18,5 en la selección (visita 1) y tengan un historial clínico coherente con NCFBE serán aptos para su inclusión en el estudio.
    E.4Principal exclusion criteria
    Subjects who have a primary diagnosis of chronic obstructive pulmonary disease or asthma, have bronchiectasis due to cystic fibrosis, hypogammaglobulinemia, common variable immunodeficiency, or α1-antitrypsin deficiency, are current smokers as defined per Centers for Disease Control and Prevention criteria, or currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis will not be eligible for enrollment in the study.
    Los sujetos con diagnóstico primario de enfermedad pulmonar obstructiva crónica o asma, que padezcan bronquiectasia debida a fibrosis quística, hipogammaglobulinemia, inmunodeficiencia variable común, o déficit de α1-antitripsina, sean fumadores habituales según la definición de los criterios de los Centros para el Control y la Prevención de Enfermedades, o estén siendo tratados actualmente por una infección pulmonar por micobacteria no tuberculosa, aspergilosis broncopulmonar alérgica o tuberculosis, no serán aptos para su inclusión en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time to the first pulmonary exacerbation over the 24-week treatment period.

    Pulmonary exacerbation definition - A pulmonary exacerbation in this study is defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician’s decision to prescribe antibiotics.
    1. Increased cough;
    2. Increased sputum volume or change in sputum consistency;
    3. Increased sputum purulence;
    4. Increased breathlessness and/or decreased exercise tolerance;
    5. Fatigue and/or malaise;
    6. Hemoptysis.

    Subjects on chronic macrolide therapy whose only change in therapy is dose or frequency adjustment will not meet the definition of exacerbation.
    El criterio de valoración principal es el tiempo que transcurre hasta la primera exacerbación pulmonar a lo largo de las 24 semanas de tratamiento.
    Definición de exacerbación pulmonar. Una exacerbación pulmonar se define en este estudio como tener 3 o más de los siguientes síntomas durante al menos 48 horas que da como resultado que un médico decida prescribir antibióticos.
    1. Aumento de la tos;
    2. aumento del volumen de esputo o cambio en su consistencia;
    3. aumento de la purulencia del esputo;
    4. aumento de la disnea (falta de aliento) y/o disminución de la tolerancia al ejercicio;
    5. fatiga y/o malestar general;
    6. hemoptisis (sangre al toser).

    Los sujetos con tratamiento crónico con macrólidos cuyo único cambio en el tratamiento sea el ajuste de la dosis o la frecuencia no cumplen con la definición de exacerbación.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time to the first pulmonary exacerbation over the 24-week treatment period.
    El tiempo que transcurre hasta la primera exacerbación pulmonar a lo largo de las 24 semanas de tratamiento.
    E.5.2Secondary end point(s)
    1. Change from Baseline in QOL-B Respiratory Symptoms Domain score over the 24-week treatment period.
    2. Change from Screening in post-bronchodilator FEV1 over the 24-week treatment period.
    3. Change in concentration of active NE in sputum from pre-treatment (defined as the average of Screening and Day 1 concentrations) to on-treatment (defined as the average of Week 12 and Week 24 concentrations).
    4. Rate of pulmonary exacerbations (number of events per person-time) over the 24-week treatment period.
    1. Cambio respecto al inicio en la escala del dominio de síntomas respiratorios del QOL-B a lo largo de las 24 semanas de tratamiento.
    2. Cambio respecto a la selección en el VEF1 posbroncodilatador a lo largo de las 24 semanas de tratamiento.
    3. Cambio en la concentración de EN activa en esputo desde el pretratamiento (definida como la media de las concentraciones de la selección y del día 1) al periodo de tratamiento (definida como la media entre las concentraciones de la semana 12 y la 24).
    4. Tasa de exacerbaciones pulmonares (número de acontecimientos por persona-tiempo) a lo largo del periodo de tratamiento de 24 semanas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over the 24-week treatment period.
    A lo largo de las 24 semanas del periodo de tratamiento
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA69
    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
    Bulgaria
    Canada
    Denmark
    France
    Germany
    Italy
    Korea, Republic of
    Netherlands
    New Zealand
    Poland
    Singapore
    Spain
    Sweden
    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
    The EOS is defined as either the date of the last visit of the last subject to complete the post-dosing follow-up (Visit 10), or the date of receipt of the last data point from the last subject that is required for primary, secondary and/or exploratory analysis, as pre-specified in the protocol, whichever is the later date.
    El fin de estudio se define como o bien la fecha de la última visita del ultimo paciente en completar el seguimiento después del tratamiento (Visita 10) o bien la fecha de recepción del último dato del último sujeto que se requiera para los análisis de objetivos primarios, secundarios o exploratorios, tal y como se especifica en el protocol, lo que ocurra más tarde.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    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 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: 96
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 144
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 240
    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)
    None
    Ninguno
    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 Decision2018-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-12
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