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    Summary
    EudraCT Number:2017-002533-32
    Sponsor's Protocol Code Number:INS1007-201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-05
    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 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
    Studio randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, multicentrico teso a valutare l’efficacia, la sicurezza e la tollerabilità, e la farmacocinetica di INS1007 somministrato una volta al giorno per 24 settimane in soggetti con bronchiectasia non dovuta a fibrosi cistica - Studio 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
    Studio teso a valutare l'efficacia e la sicurezza del farmaco in studio INS1007 somministrato una volta al giorno in pazienti con bronchiectasia non dovuta a fibrosi cistica
    A.3.2Name or abbreviated title of the trial where available
    N/A
    N/A
    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
    B.5.3.3Post codeNJ 08807 3365
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019089474393
    B.5.5Fax number0019083250386
    B.5.6E-mailkevin.schutz@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.3.2Product code [N/A]
    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.3.9.2Current sponsor codeINS1007
    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 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 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.3.2Product code [N/A]
    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.3.9.2Current sponsor codeINS1007
    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 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 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
    Bronchiectasia non dovuta a fibrosi cistica
    E.1.1.1Medical condition in easily understood language
    Non-Cystic Fibrosis Bronchiectasis
    Bronchiectasia non dovuta a fibrosi cistica
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10038738
    E.1.2Term Respiratory, thoracic and mediastinal disorders
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10006445
    E.1.2Term Bronchiectasis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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.
    Valutare l’effetto di INS1007 rispetto al placebo sul tempo alla prima riacutizzazione polmonare nel periodo di trattamento di 24 settimane.
    Valutare la sicurezza e la tollerabilità di INS1007 rispetto al placebo in base a eventi avversi (EA), segni vitali e misurazioni dell’elettrocardiogramma (ECG), esami obiettivi e valutazioni cliniche di laboratorio.
    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. Valutare l’effetto di INS1007 rispetto al placebo sulla qualità della vita (QOL), determinata in base al punteggio del dominio relativo ai sintomi respiratori del Questionario per misurare la qualità della vita nella bronchiectasia (QOLB), nel periodo di trattamento di 24 settimane.
    2. Valutare l’effetto di INS1007 rispetto al placebo sulla funzionalità polmonare, misurata in base al volume espiratorio forzato in 1
    secondo (FEV1), nel periodo di trattamento di 24 settimane.
    3. Valutare l’effetto di INS1007 rispetto al placebo sulla concentrazione di elastasi neutrofila (NE) attiva nell’espettorato, misurata
    in base alla differenza tra la concentrazione pre-trattamento (definita come la media dei valori allo screening e al Giorno 1) e la
    concentrazione durante il trattamento (definita come la media dei valori alle Settimane 12 e 24).
    4. Valutare l’effetto di INS1007 rispetto al placebo sul tasso di riacutizzazioni polmonari nel periodo di trattamento di 24 settimane.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: A PK sub-study will be conducted at a select number of sites. 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).

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Un sottostudio di farmacocinetica sarà condotto presso un numero di centri selezionati. I soggetti arruolati presso i centri selezionati saranno sottoposti a prelievi intensivi per la PK. 36 soggetrti saranno inclusi nel sottostudio PK. Per i soggetti partecipanti al sottostudio PK, la finestra temporale per la Visita 4 srà di +/- 5 giorni.
    Obiettivi di farmacocinetica:
    1. Valutatare la farmacocinetica (PK) di INS1007
    2. Valutare la relazione tra le misurazioni PK per INS 1007 e le misurazioni di efficacia, sicurezza e dei biomarcatori (per esempio, concentrazione della NE nell'espettorato e nel sangue stimolato con reagenti).
    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.
    Saranno idonei all’arruolamento nello studio quei soggetti che abbiano fornito il consenso informato firmato, di ambo i sessi e di
    età compresa tra 18 e 85 anni (compresi), con un indice di massa corporea >18,5 allo screening (Visita 1) e con un’anamnesi
    clinica coerente con l’NCFBE.
    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 a1-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.
    Non saranno idonei all’arruolamento nello studio quei soggetti che presentano una diagnosi primaria di malattia polmonare
    cronica ostruttiva o asma, bronchiectasia dovuta a fibrosi cistica, ipogammaglobulinemia, immunodeficienza variabile comune, o
    deficit di a1-antitripsina, che sono attuali fumatori secondo quanto definito dai criteri dei Centri per il controllo e la prevenzione
    delle malattie, o che attualmente ricevono un trattamento per un’infezione polmonare da micobatteri non tubercolari, aspergillosi
    broncopolmonare allergica, o tubercolosi.
    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.
    L’endpoint primario è il tempo alla prima riacutizzazione polmonare nel periodo di trattamento di 24 settimane.
    Definizione di riacutizzazione polmonare - In questo studio, per riacutizzazione polmonare si intende manifestare =3 dei seguenti sintomi per almeno 48 ore, tali da indurre la decisione di un medico di prescrivere antibiotici:
    1 aumento della tosse;
    2 aumento del volume dell’espettorato o cambiamento della consistenza dell’espettorato;
    3 aumento della purulenza dell’espettorato;
    4 aumento dell’affanno e/o ridotta tolleranza all’esercizio fisico;
    5 affaticamento e/o malessere;
    6 emottisi.
    I soggetti in terapia cronica con macrolidi la cui unica modifica terapeutica consiste in una correzione della dose o della frequenza non soddisfano la definizione di riacutizzazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time to the first pulmonary exacerbation over the 24-week treatment period.
    Il tempo alla prima riacutizzazione polmonare nel periodo di trattamento di 24 settimane.
    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 ontreatment (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. Variazione rispetto al basale nel punteggio del Dominio relativo ai sintomi respiratori del QOL-B durante il periodo di trattamento di 24 settimane.
    2. Variazione rispetto allo screening nella FEV1 post-broncodilatazione durante il periodo di trattamento di 24 settimane.
    3. Variazione nella concentrazione di NE attiva nell’espettorato dal pre-trattamento (definita come la media delle concentrazioni allo screening e al Giorno 1) al periodo di trattamento (definita come la media delle concentrazioni alla Settimana 12 e Settimana 24).
    4. Tasso di riacutizzazioni polmonari (numero di eventi per tempo-persona) durante il periodo di trattamento di 24 settimane.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over the 24-week treatment period.
    Nel periodo di trattamento di 24 settimane.
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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
    Australia
    Belgium
    Bulgaria
    Denmark
    Germany
    Italy
    Korea, Republic of
    Netherlands
    New Zealand
    Poland
    Singapore
    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
    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.
    La EOS è definita come la data dell'ultima visita dell'ultimo soggetto per completare il follow-up post-dosaggio (Visita 10), oppure
    come la data di ricezione dell'ultimo data point dall'ultimo soggetto richiesto per l'analisi primaria, secondaria e/o esplorativa,
    come pre-specificato nel protocollo, qualunque sia la data successiva.
    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 months11
    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 state12
    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
    Nessuno
    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 Decision2018-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-09
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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