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    Summary
    EudraCT Number:2020-003688-25
    Sponsor's Protocol Code Number:INS1007-301
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-23
    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 ConcernedGreece - EOF
    A.2EudraCT number2020-003688-25
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study
    A.4.1Sponsor's protocol code numberINS1007-301
    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 Switzerland GmbH
    B.5.2Functional name of contact pointRegulatory Affairs EMEA
    B.5.3 Address:
    B.5.3.1Street AddressGrafenauweg 10
    B.5.3.2Town/ cityZug
    B.5.3.3Post code6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 79 360-5890
    B.5.6E-mailcolin.urquhart@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 nameBrensocatib
    D.3.2Product code INS1007
    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 INNBrensocatib
    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.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 nameBrensocatib
    D.3.2Product code INS1007
    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 INNBrensocatib
    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.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
    E.1.1.1Medical condition in easily understood language
    Non-Cystic Fibrosis Bronchiectasis
    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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10083611
    E.1.2Term Non-cystic fibrosis bronchiectasis
    E.1.2System Organ Class 100000004855
    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 brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of brensocatib compared with placebo on the time to first PE over the 52-week treatment period
    2. To evaluate effect of brensocatib compared with placebo on the proportion of subjects who are exacerbation free over the 52-week treatment period
    3. To evaluate the effect of brensocatib compared with placebo on lung function
    4. To evaluate the effect of brensocatib compared with placebo on the rate of severe PEs over the 52-week treatment period
    5. To evaluate the effect of brensocatib compared with placebo on quality of life, as assessed by the Quality of Life Questionnaire – Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score over the 52-week treatment period
    6. To assess the safety and tolerability of brensocatib compared with placebo over the 52-week treatment period
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    This study will also comprise a pharmacokinetic/pharmacodynamic (PK/PD) sub-study and a computed tomography (CT) scan sub-study.

    The PK/PD sub-study will be conducted in a select number of sites. Subjects who agree will undergo sparse PK and PD sampling. Approximately 300 subjects will be included in the PK/PD sub-study.

    A subgroup of subjects will be included in an evaluation of lung damage through CT scan at enrollment (Screening Visit) and End of Treatment (EOT-Week 52). Those subjects will have a guided inspiratory and expiratory CT scan done during the Screening Period and at the end of 12 months of treatment. Approximately 225 subjects (75 subjects per study arm) will be included in the CT Scan sub-study.
    E.3Principal inclusion criteria
    1. Provide their signed study informed consent to participate.
    2. Male or female ≥18 years and ≤85 years of age (inclusive) at screening.
    3. BMI ≥18.5 at screening.
    4. Clinical history consistent with NCFBE (cough, chronic sputum production and/or recurrent respiratory infections) that is confirmed by chest CT demonstrating bronchiectasis affecting one or more lobes (confirmation may be based on prior chest CT).
    a. For each subject, the most recent chest CT scan (but not older than 5 years before the Screening date) will be selected for transfer to the central reading facility for confirmation of the diagnosis of NCFBE.
    b. If the CT scan cannot be read by the reviewers due to quality issues, a new CT scan will be performed.
    c. In case a chest CT Scan in the last 5 years is not available, a new chest CT scan must be obtained for confirmation of the diagnosis of NCFBE by the central reading facility.
    5. Postbronchodilator FEV1 at the Screening Visit ≥30% of predicted normal value, calculated using National Health and Nutrition Examination Survey reference equations and must have an absolute value ≥750 mL.
    6. Current sputum producer with a history of chronic expectoration of at least 3 months in the past 12 months, and able to provide sputum sample during screening (Visit 1). If a subject is unable to produce sputum spontaneously during screening, the subject will be considered a screen failure. The subject should not undergo a sputum induction procedure during screening to meet inclusion criterion.
    7. Mucopurulent or purulent sputum color assessed at the Screening Visit by color chart developed by MP Murray.
    8. At least 2 pulmonary exacerbations defined by need for antibiotic prescription by a physician for the signs and symptoms of respiratory infections in the past 12 months before the Screening Visit.
    9. Women must be post-menopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective double barrier contraception (ie, methods that in combination achieve <1% unintended pregnancy rates per year) from Day 1 to at least 90 days after the last dose. Such methods include true abstinence (refraining from heterosexual intercourse during the study); combined
    (estrogen and progestogen containing) or progestogen-only hormonal contraception associated with inhibition of ovulation and supplemented with a double barrier (preferably male condom); intrauterine devices; intrauterine hormone-releasing systems; or vasectomized partner. For women ≤45 years of childbearing potential, an additional confirmatory testing of FSH level with a threshold of >40 mIU/mL should be performed to be considered infertile.
    10. Male subjects with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose. Acceptable methods include true abstinence (refraining from intercourse during the study), combined (estrogen and progestogen-containing) or progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems.
    E.4Principal exclusion criteria
    1. A primary diagnosis of COPD or asthma as judged by the Investigator. Patients with comorbid COPD and/or asthma can be enrolled if bronchiectasis is their primary diagnosis
    2. Subjects receiving supplemental oxygen >12 hours per day.
    3. Bronchiectasis due to cystic fibrosis.
    4. Current smokers as defined per CDC.
    5. No evidence of bronchiectasis according to the BE-CT scoring system.
    6. Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections (eg, TB, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immunecompromised status, as judged by the investigator.
    7. Known history of HIV infection.
    8. Established diagnosis of hepatitis B viral infection at the time of screening, or positive for HBsAg at the time of screening.
    Subjects who have gained immunity for hepatitis B virus infection after vaccination (subjects who are HBsAg-negative, HBsAb-positive, and HBcAb-negative are eligible for the study).
    Subjects with positive HBcAb are eligible for the study only if hepatitis B virus DNA level is undetectable.
    9. Established diagnosis of HCV infection at the time of Screening. Subjects positive for hepatitis C antibody are eligible for the study only if HCV RNA is negative.
    10. Currently being treated for NTM lung infection, allergic bronchopulmonary aspergillosis, or TB.
    11. Active and current symptomatic infection by COVID-19.
    12. Unable to perform technically acceptable spirometry that meet the ATS/ERS acceptability criteria with at least 3 acceptable flow-volume curves, at least 2 of which meet the ATS/ERS repeatability criteria for FEV1 during Screening.
    13. Inability to follow the procedures of the study (eg, due to language problems or psychological disorders).
    14. Receiving medications or therapy that are prohibited as concomitant medications
    15. Started oral or inhaled antibiotics as chronic treatment for NCFBE for <3 months prior to the Screening visit.
    a. Subjects on antibiotics as chronic treatment should be on such treatment for at least 3 months prior to enrollment while meeting all other inclusion criteria and none of the exclusion criteria.
    16. Chronic treatment with oral steroids (irrespective of the indication)
    17. Subjects who have adjustments to their baseline medications within 1 month before Screening; they can be rescreened a month after the new treatment has been initiated.
    18. Abnormal renal function test result (estimated glomerular filtration rate <30 mL/min by Chronic Kidney Disease - Epidemiology Collaboration equation formula) at Screening.
    19. Active liver disease or hepatic dysfunction manifested as follows:
    a. Elevated liver function test results (ALT or AST >2 × ULN).
    b. Bilirubin >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    c. Known hepatic or biliary abnormalities, not including Gilbert's syndrome or asymptomatic gallstones.
    20. History of malignancy in the past 5 years, except completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.
    21. Previously participated in a clinical trial of brensocatib.
    22. An absolute neutrophil count <1,000/mm3 at the Screening Visit.
    23. Received any live attenuated vaccine within 4 weeks prior to the first administration of brensocatib. If a live vaccine has been administered the subject should wait 4 weeks prior to Screening. During the study, subjects may not receive any live attenuated vaccine.
    24. Significant hemoptysis (≥300 mL or requiring blood transfusion) within 6 weeks prior to the Screening Visit or during the Screening Period.
    25. Have diagnosed periodontal disease and are either:
    a. Under active management by a dentist for this condition or
    b. Are expected to have periodontal disease-related procedures within the study period.
    26. Suffering an exacerbation 4 weeks before Screening or during the Screening period. In this case, subjects will be considered a screen failure. Subjects are eligible for rescreen only after recovery and 4 weeks after last dose of antibiotic treatment
    27. Unable to comply with ≥75% of completion of electronic diary entries or have compliance issues during the Screening Period.
    28. Participated in any other interventional clinical studies within 3 months before Screening Visit.
    29. Clinical diagnosis of Papillon-Lefevre Syndrome.

    Please refer to the protocol (Section 4.1.2) for full list of the exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of PEs over the 52-week treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over the 52-week treatment period.
    E.5.2Secondary end point(s)
    1. Time to first PE over the 52-week treatment period
    2. Proportion of subjects who are exacerbation free over the 52-week treatment period
    3. Change from Baseline in postbronchodilator FEV1 (defined as the average of the Screening Visit and Baseline measurements) to the average of Week 40 and Week 52 measurements.
    4. Rate of severe PEs over the 52-week treatment period. (Severe exacerbations are defined as those requiring IV antibacterial drug treatment and/or hospitalization)
    5. Change in QOL-B, Respiratory Symptoms Domain Score from Baseline to Week 52
    6. Incidence and severity of treatment-emergent adverse events and other safety variables (eg, clinical laboratory test results, vital signs, ECG, and physical examination)
    E.5.2.1Timepoint(s) of evaluation of this end point
    over the 52-week treatment period.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 EEA160
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Denmark
    Estonia
    France
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Latvia
    Lithuania
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Peru
    Poland
    Portugal
    Russian Federation
    Serbia
    Slovakia
    Spain
    Taiwan
    Thailand
    Turkey
    Ukraine
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days29
    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: 1215
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 405
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 480
    F.4.2.2In the whole clinical trial 1620
    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.
    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 Decision2020-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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