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    Summary
    EudraCT Number:2019-003763-22
    Sponsor's Protocol Code Number:1.027.19
    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:2020-02-26
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-003763-22
    A.3Full title of the trial
    A Pragmatic Proof of Concept Study to Evaluate the Effect of Benralizumab on Mannitol Challenge in Severe Eosinophilic Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Benralizumab in Severe Asthma
    A.3.2Name or abbreviated title of the trial where available
    Benralizumab in Severe Asthma (BISA) version 2.0
    A.4.1Sponsor's protocol code number1.027.19
    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 SponsorTayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside
    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 UK Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.4Pharmaceutical form Solution for injection
    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.3.9.3Other descriptive nameFasenra
    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 Yes
    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 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
    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 Eosinophilic 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 effect of benralizumab on airway hyper-responsiveness (AHR), after 3 months of treatment, measured by mannitol challenge as the provocative dose causing a 10% fall in forced expratory volume in 1 second (FEV1) (PD10 Mannitol), from post-run-in baseline in severe eosinophilic asthma.
    E.2.2Secondary objectives of the trial
    • To assess the effect of benralizumab on AHR, after 3 months of treatment, measured by Mannitol RDR, from post run-in baseline in severe eosinophilic asthma
    • To assess changes in type 2 biomarkers: FeNO, blood eosinophils, ECP and EDN after 3 months of treatment with benralizumab
    • To assess the effect of benralizumab on pulmonary function tests: spirometry and impulse oscillometry
    • To assess changes in patient reported outcomes: ACQ6; domiciliary PEF, symptoms and reliever use after 3 months of treatment with benralizumab
    • To assess what happens to AHR, type 2 biomarkers, pulmonary function tests and patient reported outcomes after stopping benralizumab for three months
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female patients aged 18 to 75 years with severe GINA defined asthma
    • Taking a medium to high dose of ICS/LABA OR high dose ICS with another second line controller (BDP equivalent dose of ≥800µg) of step 4/5 GINA therapy.
    • Established diagnosis of persistent asthma for at least 6 months according to GINA guidelines. Diagnosis should have been properly documented at the screening visit, based on medical documentation and medical history.
    • Uncontrolled asthma as per ACQ6 ≥ 1.5
    • Forced Expiratory Volume in 1 second (FEV1) ≥ 50% predicted.
    • Mannitol PD10 ≤ 635mg at screening and Visit 1
    • Patients with or without nasal polyposis
    • Eosinophilic asthma as evidenced by
    o Eos ≥300 cells/μl at screening visit or within 6 months prior to screening OR
    o Eos ≥150 cells/μl at screening visit or within 6 months prior to screening with nasal polyps OR
    o Eos ≥ 150 cells/μl with late onset asthma or fixed airflow obstruction.
    • Ability to give informed consent.
    • Agreement for their GP to be made aware of study participation and to receive feedback as relevant to the participant’s well being.
    • Able to understand the study procedures and the risks involved.
    • Good physical and mental status, determined on the basis of the medical history and a general clinical examination at screening.
    E.4Principal exclusion criteria
    • Previously been treated with benralizumab.
    • Any other respiratory diseases such as COPD and moderate to severe bronchiectasis which in the opinion of the investigator are considered to be clinically significant and may have an impact on the study outcomes. Patients with Asthma COPD Overlap (ACO) may be included providing they meet all the other criteria.
    • Active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases).
    • Any known systemic (e.g., blood, liver, kidney, etc.) clinically significant medical condition, known significant laboratory abnormalities or communicable disease that may endanger the health or safety of the patient.
    • Asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month prior to screening visit or 3 months if hospital admission was required.
    • Any disorder that is not stable in the opinion of the Investigator.
    • Patients who are participating in the clinical phase of another interventional trial or have done so within the last 30 days or within 5 half-lives of the previous administered product (whichever is longer) before screening. Individuals who are participating in the follow-up phase of another interventional trial, or who are enrolled in an observational study, will be co-enrolled where the Coordinating Investigator of each study agree that it is appropriate.
    • Female patients who are pregnant or lactating.
    • Patients unable or unwilling to consent.
    • Patients taking non-permitted medications.
    • Patients with a history of hypersensitivity to any of the study medications components or a history of other allergy that in the opinion of the investigator contraindicates the patient’s participation.
    E.5 End points
    E.5.1Primary end point(s)
    Change in mannitol PD10 from Visit 1 (post-run-in baseline) to Visit 5
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Visit 1 (post run-in baseline) to Visit 5, following 3 doses of benralizumab treatment (12 weeks).
    E.5.2Secondary end point(s)
    Change in mannitol RDR
    FeNO
    Blood Eosinophils
    ECP
    EDN
    ACQ6
    Diary cards for PEF, symptom (morning value only) and reliever use (number of puffs)
    Spirometry
    Impulse oscillometry (IOS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Above end points will be evaluated from Visit 1(post-run-in baseline) to Visit 5.
    Also evaluate the change in mannitol PD10 and RDR from Visit 5 (end of treatment) to Visit 6 (follow-up visit)
    The change in FeNO, blood eosinohpils, ECP, EDN, ACQ6, diary cards for PEF, symptom (morning value only) and reliever use (number of puffs), spirometry and IOS from Visit 5 (end of treatment) to Visit 6 (follow-up visit) will also be evaluated.
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    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 months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 18
    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)
    Any advice regarding change of medical therapies will be sent to the participant's General Practitioner for follow up.
    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 Decision2020-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-09
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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