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    Summary
    EudraCT Number:2018-003699-11
    Sponsor's Protocol Code Number:GN17RM684
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-11-08
    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 number2018-003699-11
    A.3Full title of the trial
    Asthma Exacerbation Profile in patients on open label treatment with Benralizumab for severe eosinophilic asthma - an exploratory cohort study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Benralizumab Exacerbation Study
    A.3.2Name or abbreviated title of the trial where available
    Benralizumab Exacerbation Study
    A.4.1Sponsor's protocol code numberGN17RM684
    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 SponsorNHS Greater Glasgow and Clyde
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNHS Greater Glasgow and Clyde
    B.5.2Functional name of contact pointDr Lynsey Gillespie
    B.5.3 Address:
    B.5.3.1Street AddressClinical Research and Development, West Glasgow ACH, Dalnair Street
    B.5.3.2Town/ cityGlasgow
    B.5.3.3Post codeG3 8SW
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0)141 201 9316
    B.5.6E-mailLynsey.Gillespie@ggc.scot.nhs.uk
    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 Yes
    D.2.1.1.1Trade name Fasenra
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameFasenra
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBenralizumab
    D.3.9.1CAS number 1044511-01-4
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameNot applicable
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name Fasenra
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameFasenra
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBenralizumab
    D.3.9.1CAS number 1044511-01-4
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameNot applicable
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe Eosinophilic Asthma
    E.1.1.1Medical condition in easily understood language
    Severe asthma
    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 10068462
    E.1.2Term Eosinophilic asthma
    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 assess the inflammatory and physiological characteristics of an asthma exacerbation whilst on treatment with benralizumab for severe eosinophilic asthma.
    E.2.2Secondary objectives of the trial
    • To measure patient outcomes after 4, 16, 24, and 56 weeks of treatment with benralizumab, and assess their associations with baseline patient characteristics, in a real-world setting.
    • To study biomarkers of response.
    • To determine if improvement in early clinical response indicators at 4, 16 and 24 weeks on treatment can predict a successful response to benralizumab at one year [50% reduction of high dose oral corticosteroid courses and/or dose of maintenance steroids at the end of 56 weeks on treatment].
    • To assess the reduction in oral corticosteroid courses and/or dose of maintenance oral steroids at the end of 56 weeks of treatment with benralizumab.
    • To assess early changes in biomarkers following benralizumab at 4 weeks [link with IMI 3TR project]
    • To compare the gut and lung microbiome at baseline and after 4 weeks of benralizumab therapy [link with IMI project]
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Severe Asthma Questionnaire (SAQ) Sub-study: Further validation of a scale to measure quality of life in patients with severe asthma.
    The sub-study aims to validate a new asthma quality of life scale, the Severe Asthma Questionnaire (SAQ) by 1. providing data from factor analysis of the SAQ, 2. examining the correlations between the SAQ with five other questionnaires used in outcome research (ACQ, AQLQ, SGRQ, EQ-5D-5L, WPAI:Asthma) and 3. comparing the extent to which all six questionnaires discriminate between patients with different profiles.

    Breathomics Sub-study (Manchester and Leicester only): Pilot study investigating early and late changes in breath biomarkers on benralizumab. Aims: 1. to investigate stability in breath biomarkers before starting treatment with benralizumab. 2. to investigate changes in breath biomarkers after one, four and 12 months of treatment with benralizumab related to changes in key clinical endpoints measured at month 12 versus baseline (a. systemic steroid use, b. annual exacerbation frequency, c. blood eosinophils, d. sputum eosinophils, e. asthma control, f. asthma quality of life, g. FeNO)
    E.3Principal inclusion criteria
    - Age ≥ 18 and ≤ 80 years at Visit 1
    - able and willing to provide written informed consent and to comply with the study protocol including being able to attend for assessment during a symptomatic deterioration.
    - severe asthma confirmed after assessment by an asthma specialist, requiring treatment with high dose inhaled corticosteroids(ICS)as per BTS criteria (≥ 1000 fluticasone propionate equivalent) and ≥1 additional drug for asthma (e.g. long acting beta2 agonist (LABA)/leukotriene receptor antagonist (e.g. theophylline / long acting muscarinic antagonist) at screening [participants may be included with a lower dose of current ICS at the discretion of the investigator if previous high ICS dose had led to side effects]
    - adherent with background asthma medication in the opinion of the investigator
    - assessed and treatment optimised for any significant asthma-related co-morbidities
    - considered suitable by an asthma specialist for treatment with a monoclonal antibody to block the Interleukin-5 pathway as per local practice. Participants will have [a] recorded blood eosinophil count ≥0.3 x 109/L within the past year along with a history of either ≥ 4 asthma exacerbations requiring high dose oral corticosteroids* and/or maintenance systemic corticosteroids equivalent to prednisolone ≥5 mg/day for 6 months or longer
    OR
    [b]recorded blood eosinophil count ≥0.4 x 109/L within the past year along with a history of ≥3 asthma exacerbations requiring high dose oral corticosteroids*

    *Exacerbations of asthma in the past year will be defined as worsening of asthma symptoms leading to treatment with prednisolone ≥30 mg oral corticosteroids for ≥3 days or an increase ≥ 10mg in oral corticosteroids for at least 3 days for patients on maintenance oral steroids]
    E.4Principal exclusion criteria
    -acute exacerbation requiring high dose oral corticosteroids in the 2 weeks prior to Visit 1 or during the screening period. Such patients would be re-assessed after 2 weeks.
    - other clinically significant medical disease or uncontrolled concomitant disease that is likely, in the opinion of the investigator, to require a change in therapy or impact the ability to participate in the study.
    - history of current alcohol, drug, or chemical abuse or past abuse that would impair or risk the patient's full participation in the study, in the opinion of the investigator
    - female patients who are pregnant or lactating or planning a family
    - active lung disease other than asthma [note: controlled obstructive sleep apnoea (OSA), minor bronchiectasis, asbestos pleural plaques or old (inactive) TB scars are not exclusion criteria). Patients where an asthma-COPD overlap is suspected by the investigator are not eligible for inclusion.
    - current smoker (history of smoking including e-cigarettes in the past 3 months)prior to Visit 1
    - Treatment with any of the following prior to Visit 1 or during the study: any biologic medicine for asthma or an immunomodulating biologic agent for other conditions in the 3 months prior to Visit 1; regular use of systemic(oral/IM) corticosteroids except for the indication of asthma; an investigational agent within 30 days of visit 1 (or five half-lives of the investigational agent, whichever is longer); administration of live attenuated vaccines 30 days prior to Visit 1. Other types of approved vaccine are allowed; regular use of systemic (oral/IM) corticosteroids except for the indication of asthma or adrenal insufficiency [note: patients taking systemic steroid replacement primarily for adrenal insufficiency can be included provided they meet exacerbation inclusion criteria], ; other ongoing immunosuppressive / immunomodulating therapy (e..g. methotrexate, cyclosporine, azathioprine) other than oral corticosteroids for asthma.
    - Bronchial thermoplasty conducted within 6 months of Visit 1.
    - history of known immunodeficiency disorder including a previous positive HIV test
    - Active or suspected Helminth infectionpatients with helminth infections must be excluded until the infection has been treated.
    - known hypersensitivity to benralizumab (the active substance) or any of the excipients (Histidine, Histidine hydrochloride monohydrate, Trehalose dihydrate, Polysorbate 20, water for injections)
    - women of childbearing potential who are not willing to use highly effective contraception during treatment with benralizumab and for 16 weeks after the last dose. WoCBP will be required to undergo a urine pregnancy test prior to on-siteadministration of each benralizumab injection.Pregnancy testing will be in accordance with standard care requirements for participants converted to local NHS benralizumab supply arrangements.
    13. Current malignancy, or history of malignancy, except for:
    a) Patients who have had non-melanoma skin cancers or in situ carcinoma of the cervix – these patients are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent is obtained
    12.b) Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent is obtained.
    E.5 End points
    E.5.1Primary end point(s)
    The main aim of the study is to assess the inflammatory and physiological characteristics of an asthma exacerbation whilst on treatment with benralizumab for severe eosinophilic asthma.

    Key exploratory outcomes will be blood eosinophil counts, fall in lung function, exhaled Nitric Oxide change in asthma symptom scores and number of patients progressing to rescue oral corticosteroids during a clinical deterioration whilst on benralizumab.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Exacerbation events at any time whilst on treatment with benralizumab
    E.5.2Secondary end point(s)
    • To measure patient outcomes after 16, 24, and 56 weeks of treatment with benralizumab, and assess their associations with baseline patient characteristics, in a real-world setting.
    • To study biomarkers of response.
    • To determine if improvement in early clinical response indicators at 16 and 24 weeks on treatment can predict a successful response to benralizumab at one year [50% reduction of high dose oral corticosteroid courses and/or dose of maintenance steroids at the end of 56 weeks on treatment].
    • To assess the reduction in oral corticosteroid courses and/or dose of maintenance oral steroids at the end of 56 weeks of treatment with benralizumab.
    - Early changes at 4 weeks compared to baseline
    • Blood eosinophil counts
    • Sputum eosinophils
    • Blood neutrophil counts
    • Exhaled nitric oxide
    • Nasosorption eosinophil markers
    • ACQ-6, SGRQ, mini-ACLQ
    • FEV1
    • Stool microbiome compared to lung microbiome and biomarkers in blood and sputum [measured within the 3TR IMI Programme]
    • Oral Wash microbiome

    E.5.2.1Timepoint(s) of evaluation of this end point
    4, 16, 24 and 56 weeks after initiation of treatment.
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned14
    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 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
    3 months after the LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days2
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state150
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 150
    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)
    Participants will return to standard care at the end of their involvement in the study. The investigator will discuss the treatment options available for the participant which will be guided by local and national guidelines at the time of their last visit.
    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 Decision2019-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-13
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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