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    Summary
    EudraCT Number:2017-003679-75
    Sponsor's Protocol Code Number:SG015
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-10-06
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-003679-75
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled study, in COPD patients with and without a confirmed respiratory virus infection assessing anti-viral biomarker responses and clinical effects of inhaled SNG001 compared to placebo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test a potential new treatment for COPD patients suffering from the common cold or influenza.
    A.3.2Name or abbreviated title of the trial where available
    Inhaled SNG001 in COPD patients
    A.4.1Sponsor's protocol code numberSG015
    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 SponsorSynairgen Research Limited
    B.1.3.4CountryUnited Kingdom
    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 supportSynairgen Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSynairgen Research Limited
    B.5.2Functional name of contact pointJody Brookes
    B.5.3 Address:
    B.5.3.1Street AddressMail Point 810, Southampton General Hospital
    B.5.3.2Town/ citySouthampton
    B.5.3.3Post codeSO16 6YD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02380512900
    B.5.5Fax number02380512800
    B.5.6E-mailjody.brookes@synairgen.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 nameInterferon beta-1a (IFN-β1a)
    D.3.2Product code SNG001
    D.3.4Pharmaceutical form Nebuliser solution
    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 INNInterferon beta-1a
    D.3.9.1CAS number 145258-61-3
    D.3.9.2Current sponsor codeSNG001
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit million IU million international units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboNebuliser solution
    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 Chronic Obstructive Pulmonary Disease (COPD). In part 1 of the study the patients are in stable state. In part 2 of the study patients have a respiratory virus infection (i.e. cold or flu virus).
    E.1.1.1Medical condition in easily understood language
    COPD is a disease of the airways resulting in breathing difficulties. The most common cause is smoking.
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10010953
    E.1.2Term COPD exacerbation
    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
    We want to see if SNG001 activates antiviral defences in the lungs of people with COPD. We are interested in doing this because COPD patients often suffer badly when they get colds, it seems that the colds really hit their chest. SNG001 is an inhaled form of interferon beta, an antiviral protein we all make when we have a viral infection. Data has shown that interferon beta boosts COPD cell defences in the laboratory. We hope we can boost the lungs defences in COPD patients by delivering SNG001 by inhaler directly into the lungs of patients when they have a confirmed virus infection. We can measure this in sputum (phlegm) during the trial.
    E.2.2Secondary objectives of the trial
    We will also want to see if lung function and symptoms scores suggest a potential clinical benefit of SNG001. This will help with the design of future trials.

    SNG001 has been delivered safely to more than 130 asthma patients before, and it showed some clinical benefit, this is the first time it has been delivered to COPD patients, so we will dose 10 (8 SNG001, 2 placebo) patients when they haven’t got a cold, before moving onto the main part of the study, where 80 patients will be dosed. Thus an important aspect of the trial is the assessment of the safety of SNG001 in COPD patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    PART 1
    1. Male or female, between and including 40-75 years of age, at the time of the screening visit.
    2. A confirmed physician diagnosis of COPD or a medical history consistent with a diagnosis of COPD for at least 12 months prior to the screening visit.
    3. Post bronchodilator FEV1/FVC ratio <0.7.
    4. Post bronchodilator FEV1 ≥40% of predicted (at screening and post sputum induction pre-dose).
    5. Should have stable COPD, having no symptoms of an exacerbation and/or respiratory tract infection currently and/or within the past 6 weeks of screening and/or randomisation.
    6. Should be prescribed and taking regularly one or more long acting bronchodilator (e.g. long acting β2 agonist (LABA), long acting muscarinic antagonist [LAMA]) with or without an inhaled corticosteroid maintenance therapies for their COPD.
    7. Patients who produce sputum most days.
    8. Provide written informed consent.
    9. The patient produced an adequate sputum sample at the screening visit.
    10. Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception. Acceptable birth control methods are stated in the protocol. Women should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose of inhaled IFN-β-1a/matching placebo. In addition to the acceptable birth control method (except for the practice of total sexual abstinence), condom (in UK with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose of inhaled IFN-β-1a/matching placebo to prevent pregnancy.
    Women not of childbearing potential are defined in the protocol.
    11. Motivation (in the Investigator’s opinion) to comply with protocol requirements and complete all study visits, including the ability to communicate well with the Investigator and be capable of understanding the nature of the research and its treatment (including its risks and potential benefits).

    PART 2
    1. Male or female, between and including 40-85 years of age at the time of the consent visit.
    2. A confirmed physician diagnosis of COPD or a medical history consistent with a diagnosis of COPD for at least 12 months prior to the consent visit.
    3. Post bronchodilator FEV1/FVC ratio <0.7.
    4. Post bronchodilator FEV1 ≥30% of predicted.
    5. To have had 1 or more COPD exacerbations in the last 12 months requiring intervention with oral corticosteroids and/or antibiotics.
    6. Patient reported evidence that a respiratory virus has made their COPD significantly worse in the past.
    7. Patients who have chronic bronchitis OR produce sputum on most days.
    8. Should be prescribed and taking regularly one or more long acting bronchodilator (e.g. LABA, LAMA) with or without an inhaled corticosteroid mainte nance therapy for their COPD.
    9. Patients on self-management plans agree to consult a healthcare professional prior to taking oral corticosteroids or antibiotics for treatment of a COPD exacerbation.
    10. Provide written informed consent.
    11. Be the owner or user of a mobile phone and be able to and agree to respond to the required SMS messages for the trial.
    12. Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception. Acceptable birth control methods are stated in the protocol. Women should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose of inhaled IFN-β-1a/matching placebo. In addition to the acceptable birth control method (except for the practice of total sexual abstinence), condom (in UK with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose of inhaled IFN-β-1a/matching placebo to prevent pregnancy.
    Women not of childbearing potential are defined in the protocol.
    13. Motivation (in the Investigator’s opinion) to comply with protocol requirements and complete all study visits, including the ability to communicate well with the Investigator and be capable of understanding the nature of the research and its treatment (including its risks and potential benefits).


    E.4Principal exclusion criteria
    PART 1
    1. Any condition, including findings in the medical history or in the pre-randomisation assessments that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the patient in the study or that could interfere with the study objectives, conduct or evaluation.
    2. Current treatment or treatment within the past 6 weeks with oral corticosteroids or other systemic immunosuppressive.
    3. Oxygen saturation of ≤ 92%.
    4. Patients who require any form of oxygen therapy or non-invasive ventilation.
    5. The patient has received live vaccines in the past six weeks prior to randomisation or attenuated vaccines in the past two weeks prior to randomisation.
    6. Current or previous participation in another clinical trial where the patient has received a dose of an investigational medicinal product (IMP) containing small molecules within 12 weeks prior to entry into this study or containing biologicals within 12 months prior to entry into this study.
    7. Active interstitial lung disease or past history of lung cancer not considered cured, significant bronchiectasis, cystic fibrosis, alpha1 antitrypsin deficiency or a history of significant chronic asthma.
    8. Patients who currently have, or have had within the past 3 months, any significant underlying medical condition(s) that could impact the interpretation of results (see protocol for examples)
    9. History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation.
    10. Significant history of depressive disorder or suicidal ideation. Specifically, individuals with current severe depression (see protocol for examples) individuals with a past history of depression that required hospitalisation or referral to psychiatric services in the past 5 years; individuals who currently feel suicidal or have attempted suicide in the past.
    11. Patients who are currently receiving anti-epileptic therapy and/or have uncontrolled epilepsy.
    12. History of drug or alcohol abuse within 12 months prior to enrolment.
    13. Female who is breast-feeding, pregnant or intends to become pregnant.
    14. Patients with clinically significant arrhythmias or implantation of permanent pacemaker or implanted cardiac defibrillator
    15. Patients with unstable ischaemic heart disease (including, but not limited to, unstable angina, myocardial infarction within the preceding 6 months).

    PART 2
    1. Any condition, including findings in the medical history or in the pre-study assessments that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the patient in the study or that could interfere with the study objectives, conduct or evaluation.
    2. The patient currently has or has had any of the following within the past 6 weeks:
    a. A moderate or severe exacerbation of COPD (Appendix A: Exacerbations definitions (GOLD 2017)).
    b. An upper or lower respiratory tract infection
    Note: there should be at least 6 weeks between the resolution of any of the above and the patient entering the study.
    3. Oxygen saturation of ≤92%.
    4. Patients who require any form of oxygen therapy.
    5. Current or previous participation in another clinical trial where the patient has received a dose of an investigational medicinal product (IMP) containing small molecules within 12 weeks prior to entry into this study or containing biologicals within 12 months prior to entry into this study.
    6. Active interstitial lung disease or past history of lung cancer not considered cured, significant bronchiectasis, cystic fibrosis, alpha-1 antitrypsin deficiency or a history of significant chronic asthma.
    7. Patients who currently have, or have had within the past 3 months, any significant underlying medical condition(s) that could impact interpretation of results (see protocol for examples)
    8. History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation.
    9. Significant history of depressive disorder or suicidal ideation. Specifically, individuals with current severe depression (see protocol for examples) individuals with a past history of depression that required hospitalisation or referral to psychiatric services in the past 5 years; individuals who currently feel suicidal or have attempted suicide in the past.
    10. Patients who are currently receiving anti-epileptic therapy and/or have uncontrolled epilepsy.
    11. History of drug or alcohol abuse within 12 months prior to enrolment.
    12. Patients with clinically significant arrhythmias or implantation of permanent pacemaker or implanted cardiac defibrillator
    13. Patients with unstable ischaemic heart disease
    14. Female who is breast-feeding, pregnant or intends to become pregnant.

    E.5 End points
    E.5.1Primary end point(s)
    Part 1
    The following outcome measures will be used to assess respiratory function, induction of biomarkers and general safety and tolerability as co-primary endpoints of equal importance:
    - Forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEFR).
    - Changes in sputum differential cell counts
    - Anti-viral IFN-stimulated genes (eg, MXA, 2’-5’ OAS, GBP1, IFIT2, CXCL10) in cells from expectorated sputum
    - General safety and tolerability measures including changes in incidence of adverse events, vital signs, ECG readings, haematology, blood chemistry, coagulation and urinalysis.

    Part 2
    The following outcome measures will be used to assess induction of anti-viral biomarkers, efficacy and general safety and tolerability as co-primary endpoints of equal importance:
    - Anti-viral IFN-stimulated genes (eg, MXA, 2’-5’ OAS, GBP1, IFIT2, CXCL10) in cells from expectorated sputum
    - CXCL10 in blood samples
    - Changes in FEV1 and PEFR during the study period
    - Changes in Breathlessness, cough and sputum scale (BCSS) score and time to return to normal symptoms post a moderate exacerbation (Group B only)
    - Sputum viral and bacterial load
    - Reliever medication usage during the treatment period
    - Antibiotic and oral corticosteroid usage during the study period
    - General safety and tolerability measures including changes in incidence of adverse events, vital signs, ECG readings, haematology, blood chemistry, coagulation and urinalysis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Included above (E5-1).
    E.5.2Secondary end point(s)
    There are no secondary endpoints for this study. This is a Phase II exploratory study which aims to both confirm the effect of inhaled SNG001 on the upregulation of IFN-β driven anti-viral biomarkers in conjunction with assessing impact on efficacy and safety measures for COPD patients with and without respiratory viral induced exacerbations. As such, the outcome measures assessed during the study are considered of equal importance to meet the study objectives and are listed as co-primary endpoints in section E5-1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable.
    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 Yes
    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 No
    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 concerned7
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 130
    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)
    Medication will not be provided by the sponsor to study subjects at the end of the trial. After the end of study visit is performed, patient's routine standard of care will continue.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-01
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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