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    Summary
    EudraCT Number:2013-001951-11
    Sponsor's Protocol Code Number:AQX-1125-202
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-11
    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 ConcernedSweden - MPA
    A.2EudraCT number2013-001951-11
    A.3Full title of the trial
    The FLAGSHIP Study: A 12-week Phase II Study to Evaluate the Efficacy and Safety of AQX-1125 Following Exacerbations in Patients with Chronic Obstructive Pulmonary Disease (COPD) by targeting the SHIP1 Pathway
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of AQX-1125 in patients with lung attacks
    A.3.2Name or abbreviated title of the trial where available
    FLAGSHIP: AQX-1125 in patients with exacerbations of COPD
    A.4.1Sponsor's protocol code numberAQX-1125-202
    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 SponsorAquinox Pharmaceuticals Inc.
    B.1.3.4CountryCanada
    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 supportAquinox Pharmaceuticals Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTFS Trial Form Support AB
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressBox 165
    B.5.3.2Town/ cityLund
    B.5.3.3Post code22100
    B.5.3.4CountrySweden
    B.5.4Telephone number+46462801800
    B.5.5Fax number+46462801801
    B.5.6E-mailmonica.olsson@tfscro.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 nameAQX-1125
    D.3.2Product code AQX-1125
    D.3.4Pharmaceutical form Capsule
    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 INNAQX-1125
    D.3.9.1CAS number 782487-29-0
    D.3.9.2Current sponsor codeAQX-1125
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboCapsule
    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
    Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
    E.1.1.1Medical condition in easily understood language
    Lung attacks
    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
    The primary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on recurrent exacerbations as measured by EXACT (EXAcerbation of Chronic pulmonary disease Tool) in subjects with COPD following a recent exacerbation.
    E.2.2Secondary objectives of the trial
    To evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on:
    • The COPD Assessment Tool (CAT) score
    • Pulmonary function (including but not limited to forced expiratory volume in 1 second [FEV1])
    • The frequency and severity of adverse events (AEs) and changes in, physical examination, vital signs, ophthalmic examination, laboratory tests, weight, electrocardiogram (ECG), and concomitant medications
    • The pharmacokinetics (PK) of AQX-1125 in plasma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide written informed consent and be willing and able to comply with all aspects of the study requirements
    2. Male or female aged ≥40 years at screening
    3. History of COPD for at least 18 months prior to screening, characterised by excessive sputum production
    4. Chronic productive cough for at least 3 months in each of the 2 years prior to screening (if other causes of productive cough have been excluded) and/or an exacerbation of COPD with predominantly bronchitic symptoms at enrolment
    5. At least 2 documented exacerbations during the last 18 months prior to screening.
    If the subject has experienced exacerbations during the last 18 months that were self-treated at home and subsequently documented by a physician, this can be documented at Visit 1
    6. Presentation of a diagnosed acute exacerbation of COPD, or have recently (within 3 days) been discharged from hospital due to an acute exacerbation of COPD
    7. Ability to perform pulmonary function testing and with documented fixed airway obstruction determined by an FEV1 /forced vital capacity (FVC) ratio (post-bronchodilator) of <0.70 and a predicted FEV1 value of 30%-80% of normal within the 6 months prior to or at Visit 1
    8. Former smoker or current smoker, both with a smoking history of at least 10 pack years
    9. Female subjects should be of non-child bearing potential. They should be one year or more post-menopause, previously surgically sterilised, or have had a hysterectomy. From the screening visit until 1 month after last dose of investigational medicinal product (IMP), male subjects must agree to use condoms with any sexual intercourse with women of child bearing potential and have partners who use adequate methods of contraception (e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, or combination birth control pills). If male subjects have had a confirmed vasectomy use of condoms is not required.
    E.4Principal exclusion criteria
    1. Diagnosis of other relevant lung disease (e.g. asthma, cystic fibrosis [CF] or significant non-CF bronchiectasis)
    2. Known alpha-1-antitrypsin deficiency
    3. Treatment with roflumilast or theophylline within 1 month prior to screening
    4. History of alcohol or drug abuse in the past 3 years prior to screening
    5. Participation in another clinical research study within 90 days prior to screening
    6. Lobar pneumonia, with current positive chest X-ray (CXR) or within the 3 months prior to screening including the presence of any new radiological infiltrate on CXR within the previous two weeks
    7. Have any other conditions, disease or circumstances which, in the opinion of the Investigator, could compromise safety of the subject or confound the interpretation of the study results. This will include a relevant documented medical history of clinically significant irregularities in kidney function, liver function or blood counts; or malignant or premalignant irregularities of the urinary bladder.
    8. Serious and/or life-threatening co-existing conditions that would merit acute hospitalisation, aside from the acute exacerbation event
    These include, but are not limited to, acute myocardial infarction, acute renal failure, acute pancreatitis, thromboembolic disease, and diabetic ketoacidosis
    9. Hospitalisation for more than 7 days for current acute exacerbation, or the requirement for intubation during hospitalisation
    10. For outpatients, prior medical history indicating that previous exacerbations required >3 weeks to stabilise
    11. Known intolerance to micro-crystalline cellulose (Avicel® PH-102)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the difference in the “area above the curve” (AAC) for the daily EXACT score from baseline to Week 12 between subjects treated with AQX-1125 and subjects treated with placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Twelve weeks
    E.5.2Secondary end point(s)
    • The difference in number of COPD exacerbations and time to first COPD exacerbation between subjects treated with AQX-1125 or placebo
    • The difference in change from baseline in CAT score between subjects treated with AQX-1125 or placebo
    • The difference in change from baseline in pulmonary function (FEV1, expressed in litres and as percent predicted normal) between subjects treated with AQX 1125 and subjects treated with placebo
    • The difference in number and frequency of AEs, physical examination, ECG, ophthalmology examination, and concomitant medications and changes from baseline for clinical laboratory assessments and vital signs between subjects treated with AQX 1125 and subjects treated with placebo
    • Trough AQX-1125 concentrations in plasma
    E.5.2.1Timepoint(s) of evaluation of this end point
    Twelve weeks
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    New Zealand
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Last visit of the last patient remaining in the study
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months14
    E.8.9.2In all countries concerned by the trial days16
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 300
    F.4.2.2In the whole clinical trial 400
    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)
    Standard care
    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 Decision2013-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-13
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