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    Summary
    EudraCT Number:2017-003675-61
    Sponsor's Protocol Code Number:D3252C00001
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-12-20
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2017-003675-61
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients with Severe Nasal Polyposis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety Study of Benralizumab for Patients with Severe Nasal Polyposis
    A.3.2Name or abbreviated title of the trial where available
    OSTRO
    A.4.1Sponsor's protocol code numberD3252C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03401229
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressVastra Malarehamnen 9
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.6E-mailinformation.center@astrazeneca.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 nameBenralizumab administered via accessorized pre-filled syringe (APFS)
    D.3.2Product code MEDI-563
    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.3.10 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 Yes
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nasal polyposis
    E.1.1.1Medical condition in easily understood language
    Nasal polyposis (NP) is a chronic inflammatory disease of the nasal mucosa characterized by the presence of polyps in the upper nasal cavity.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028754
    E.1.2Term Nasal polyp
    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 benralizumab on nasal polyp burden and patient reported nasal blockage
    E.2.2Secondary objectives of the trial
    To evaluate the effect of benralizumab on:
    - disease specific health-related quality of life (HRQoL)
    - nasal polyp surgery and/or SCS use
    - sense of smell
    - systemic corticosteroids (SCS) use for relief of nasal symptoms
    - symptoms associated with nasal polyps
    - sinus opacification by computed tomography (CT) scan (subset of patients)
    - patient-reported general health status

    Safety objectives:
    - to assess the safety of benralizumab
    - to assess the pharmacokinetics and immunogenicity of benralizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in protocol.
    2. Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses and according to international guidelines and/or applicable EU guidelines.
    3. Provision of signed and dated written genetic informed consent in patients that agree to participate in the genetic sampling, prior to collection of sample for genetic analysis.
    4. Female or male patients aged 18 to 75 years inclusive, at the time of signing the ICF.
    5. Patients with bilateral sinonasal polyposis that, despite treatment with a stable dose of intranasal corticosteroids (INCS) for at least 4 weeks prior to V1, in addition to a history of treatment with systemic corticosteroids (SCS -oral, parenteral) or prior surgery for nasal polyposis (NP), have severity consistent with a need for surgery as described by:
    - A minimum total Nasal Polyp Score (NPS) of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril) at V1 and continuously maintained at V2 to meet the randomization criterion, as determined by the study Imaging Core Lab;
    - Ongoing symptoms for at least 12 weeks prior to V1;
    - Patient-reported moderate to severe nasal blockage score (NBS) 2 or 3 over the 2-weeks prior to V1 (2-week recall assessment of symptoms, scores 0-none to 3-severe).
    6. SNOT-22 total score ≥ 30 at enrolment (V1).
    Patient must meet the following criteria (points 7-10) at the randomization visit (V3):
    7. At least 8 days of evaluable daily diary data in the 14-day period prior to randomization (baseline bi-weekly mean score collected from study Day -13 to study Day 0).
    8. At randomization, a bi-weekly mean NBS ≥ 1.5.
    9. SNOT-22 total score ≥ 30 at randomization (V3).
    10. At least 70% compliance with INCS during the run-in period based on daily diary.
    11. Patients with a minimum weight of 40kg.
    12. Negative serum pregnancy test result at V1 and a negative urine pregnancy test at randomization for female patients of childbearing potential.
    13. Women of childbearing potential (WOCBP) must use an effective form of birth control (confirmed by the Investigator) eg, total sexual abstinence, a vasectomized sexual partner, Implanon. Female sterilization by tubal occlusion, any effective IUD intrauterine device/IUS levonorgestrel Intrauterine system, Depo-ProveraTM injections, oral contraceptive, Evra PatchTM, or NuvaringTM. Women of childbearing potential must agree to use highly effective method of birth control, as defined above, from enrolment, throughout the study duration and for 16 weeks after the last dose of investigational product (IP).
    14. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considerd postmenopausal if they have been amenorrheic for 12 months prior to the planned date of the randomization without alternative medical cause. The following age specific requirements apply:
    - Women <50 years old are considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and if follicle stimulating hormone (FSH) levels are in the postmenopausal range;
    - Women ≥ 50 years old are considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
    15. Male subjects who are sexually active must be surgically sterile at least one year prior to Visit 1 or must use an adequate method of contraception (condom or condom with spermicide depending on local regulations) from the first dose of IP until 16 weeks after their last dose. Men with a partner or partners who is (are) not of childbearing potential are exempt of these requirements
    E.4Principal exclusion criteria
    1. Patients who have undergone any nasal and/or sinus surgery within 3 months prior to V1.
    2. Patients with conditions or concomitant disease that makes them non evaluable for the co-primary efficacy endpoint such as:
    - Unilateral antrochoanal polyps;
    - Nasal septal deviation that occludes at least one nostril;
    - Acute sinusitis, nasal infection, or upper respiratory infection at screening or in the 2 weeks before screening;
    - Current rhinitis medicamentosa;
    - Allergic fungal rhinosinusitis (AFRS) or Allergic fungal sinusitis (AFS);
    - Nasal cavity tumors.
    3. Clinically important comorbidities that could confound interpretation of clinical efficacy results including, but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, primary ciliary dyskinesia, eosinophilic diseases other than asthma (eg, allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangitis [Churg-Strauss syndrome], hypereosinophilic syndromes), granulomatosis with polyangitis (Wegener's granulomatosis), Young’s syndrome, etc.
    4. Any disorder, including but not limited to: cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator or AstraZeneca and could:
    - Affect the safety of the patient throughout the study;
    - Influence the findings of the studies or their interpretations;
    - Impede the patient’s ability to complete the entire duration of study.
    5. Patients experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalization (>24hrs) for treatment of asthma within 4 weeks prior to V1.
    6. History of anaphylaxis to any biologic therapy or vaccine.
    7. Known history of allergy or reaction to any component of the IP formulation.
    8. History of Guillain-Barré syndrome.
    9. A helminth parasitic infection diagnosed within 24 weeks prior to V1 and has not been treated with, or has failed to respond to standard of care therapy.
    10.Current malignancy, or history of malignancy with specific exceptions.
    11.Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which may put the patient at risk or interfere with study assessments.
    12. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology (confirmed by additional testing, e.g. hepatitis C RNA test, if indicated), or a positive medical history for hepatitis B or C. (Note: Patients with history of hepatitis B vaccination without history of hepatitis B are allowed to enrol).
    13. History of known immunodeficiency disorder, including a positive human immunodeficiency virus (HIV) test.
    14. Infection requiring systemic antibiotics (Ab) within 14 days prior to V1.
    15. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, or any experimental anti-inflammatory therapy) within 3 months prior to V1.
    16. Receipt of any marketed or investigational biologic products (monoclonal or polyclonal antibody) within 6 months or 5 half-lives, whichever is longer, prior to V1. This also applies to patients who previously participated in clinical studies and were treated with monoclonal antibodies (e.g. mepolizumab, reslizumab, dupilumab, omalizumab). Note that this restriction do not apply to patients, who are confirmed to have only received treatment with placebo.
    17. Previous receipt of benralizumab.
    18. Receipt of immunoglobulin or blood products within 30 days prior to V1.
    19. Receipt of live attenuated vaccines 30 days prior to the date of randomization.
    20. Receipt of any investigational drug within 30 days or 5 half-lives whichever is longer prior to randomization.
    21. Receipt of systemic corticosteroid 4 weeks prior to V1, or a scheduled systemic corticosteroid treatment during the study period. NOTE: Sustained release steroids (e.g. Kenalog [Triamcinolone acetonide]) or depot injections require minimum 6 weeks washout prior to V1.
    22. Receipt of leukotriene antagonist/modifiers for patients who were not on a continuous stable dose for ≥30 days prior to V1.
    23. Concurrent enrolment in another clinical drug interventional trial.
    24. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 3 times the upper limit of normal (ULN) confirmed during screening period.
    25. Previous randomization in the present study.
    26. Planned major surgical procedures or scheduled NP surgery at the time of the study enrolment and randomization.
    27. Initiated or is being maintained on an aspirin desensitization regimen for the
    management of AERD (aspirin exacerbated respiratory disease) at the time of study enrolment or during the run in period.
    28. For women only – currently pregnant (or intend to become pregnant), breastfeeding or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    - change from baseline in endoscopic total nasal polyp score
    - change from baseline in mean nasal blockage score
    E.5.1.1Timepoint(s) of evaluation of this end point
    - following the first administration of study drug through week 56
    E.5.2Secondary end point(s)
    - change from baseline in SinoNasal Outcome Test (SNOT-22) score
    - time to first NP surgery
    - time to first NP surgery and/or SCS use for NP
    - proportion of patients with surgery for NP
    - proportion of patients with SCS use for NP
    - time to first SCS course for NP, number of courses of SCS for NP, total SCS dose used and total duration of SCS use for NP
    - change from baseline in nasal symptom score(s) as captured in the daily diary
    - sense of smell captured as change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score
    - change from baseline in Lund Mackay score and sinus severity score by Quantitative CT analysis (subset of patients)
    - change from baseline in Short Form 36-item Health survey, Version 2 (SF-36v2), Physical Component Score (PCS), Mental Component Score (MCS) and domains
    - adverse events and serious adverse events
    - laboratory variables
    - serum PK
    - benralizumab anti-drug antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    - following the first administration of study drug through week 56
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    Approx.1st 200Pts who complete treatment enter 6mths FollowUP.CT done in Pts subset at chosen sites
    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 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
    Austria
    Belgium
    Canada
    Denmark
    Germany
    Hungary
    Poland
    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 expected visit/contact of the last patient undergoing the study.
    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 months11
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days12
    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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 258
    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)
    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 Decision2018-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-31
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