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    Summary
    EudraCT Number:2020-000195-38
    Sponsor's Protocol Code Number:D3252C00004
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-07-16
    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 ConcernedAustria - BASG
    A.2EudraCT number2020-000195-38
    A.3Full title of the trial
    A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Benralizumab for the Prevention of Recurrence of Nasal Polyps Following Surgical Removal in Patients with Chronic Rhinosinusitis with Nasal Polyps (OXALIS)
    Eine multizentrische, randomisierte, doppelblinde, placebokontrollierte Parallelgruppenstudie der Phase III zur Wirksamkeit und Sicherheit von Benralizumab als Prävention von Rezidiven von nasalen Polypen nach chirurgischer Entfernung bei Patienten mit chronischer Rhinosinusitis mit Nasenpolypen (OXALIS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of benralizumab for prevention of nasal polyps recurrence following endoscopic sino-nasal surgery
    Wirksamkeit und Sicherheit von Benralizumab zur Vorbeugung des Wiederauftretens von Nasenpolypen nach endoskopischer Nasenoperation
    A.3.2Name or abbreviated title of the trial where available
    OXALIS
    A.4.1Sponsor's protocol code numberD3252C00004
    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
    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.3.9.2Current sponsor codeMEDI-563
    D.3.9.3Other descriptive nameBenralizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    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
    Nasenpolypen
    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.
    Nasenpolypose (NP) ist eine chronisch entzündliche Erkrankung der Nasenschleimhaut, die durch das Vorhandensein von Polypen in der oberen Nasenhöhle gekennzeichnet ist.
    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
    To evaluate the effect of benralizumab vs placebo on the post-surgical recurrence of nasal polyps associated with worsening in CRSwNP (chronic rhinosinusitis with nasal polyposis) health status and/or clinical intervention
    E.2.2Secondary objectives of the trial
    To evaluate the effect of benralizumab vs placebo on:

    - the post-surgical recurrence of nasal polyps
    - CRSwNP (chronic rhinosinusitis with nasal polyposis) health status associated with post-surgical recurrence of nasal polyps
    - changes in clinical interventions associated with post-surgical recurrence of nasal polyps
    - SCS use for relief of NP symptoms and/or the need for additional surgery
    - Nasal polyposis-associated symptoms
    - sense of smell
    - general HRQoL (Health-related quality of life)
    - sinus opacification (Lund-Mackay Score)

    Safety objectives:
    - To assess the safety and tolerability of benralizumab
    - To assess the pharmacokinetics and immunogenicity of benralizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participants with bilateral sinonasal polyposis, and prior use of SCS (unless a medical contraindication) and ESS within 3 years, who have severity consistent with a need for surgery as described by:
    (a) A minimum total NPS of 4 out of a maximum score of 8 (with a unilateral score of at least 1 for each nostril) at V1 as determined by the study imaging core lab,
    (b) Ongoing symptoms for at least 12 weeks prior to V1 (question 11 of NPSQ);
    (c) Sinonasal symptom (SNOT-22) total score ≥ 30 at enrolment (V1)

    Participant must meet the following criteria at the randomisation visit (V3):
    - Completion of surgical procedures consistent with those described in the Pre randomisation Surgical Guideline
    - Successful surgical polyp removal as evidenced by no visible polyps, confirmed by the Investigator
    - SNOT-22 improvement greater than or equal to the MCID of 8.9 compared to the assessment prior to surgery
    E.4Principal exclusion criteria
    - Participants with conditions or concomitant disease that makes them non-evaluable for the efficacy endpoint such as:
    (a) Unilateral antrochoanal polyps
    (b) Nasal septal deviation that occludes at least one nostril so as to prevent NPS scoring
    (c) Current rhinitis medicamentosa
    (d) Allergic fungal rhinosinusitis or allergic fungal sinusitis
    (e) Nasal cavity tumours

    - 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.

    - Participants experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalisation (> 24 hrs) for treatment of asthma within 4 weeks prior to V1.
    - Participants should not be randomised in case of persistent or new post-surgical infection (eg, fever or nasal muco-purulent discharge), uncontrolled pain, acute sinusitis, nasal infection, or upper respiratory infection in the 2 weeks before randomisation
    - History of anaphylaxis to any biologic therapy or vaccine.
    - A helminth parasitic infection diagnosed within 24 weeks prior to the date of informed consent and has not been treated with, or has failed to respond to standard of care therapy.
    E.5 End points
    E.5.1Primary end point(s)
    Time from randomisation to the earliest recurrence of nasal polyps associated with SNOT-22 worsening and/or a clinical intervention.
    - Recurrence of nasal polyps will be determined by an NPS showing an increase ≥ 1 from that recorded at baseline
    - SNOT-22 worsening is defined as a clinically meaningful deterioration in SNOT-22 compared to baseline (worsening ≥ 8.9 [MCID - Minimum clinically importance difference])
    - Clinical intervention is defined as a need for NP surgery, SCS use for NP, or need for a biologic.
    E.5.1.1Timepoint(s) of evaluation of this end point
    through the end of the treatment period
    E.5.2Secondary end point(s)
    - Time from randomisation to the earliest post-baseline timepoint with an increase in NPS compared to baseline (increase ≥ 1), which is confirmed at the next assessment at least 4 weeks later (key secondary)

    - Time from randomisation to the earliest post-baseline timepoint with a clinically meaningful deterioration in SNOT-22 compared to baseline (worsening ≥ 8.9 [MCID] [Minimum clinically importance difference]), which is confirmed at the next assessment at least 4 weeks later (key secondary)

    - Change from baseline in SNOT-22 [SinoNasal Outcome Test 22 item]

    - Time from randomisation to the first clinical intervention (need for NP surgery, SCS , need for a biologic) due to nasal polyps recurrence (key secondary)

    - Time from randomisation to first SCS burst for NP
    - Time from randomisation to need for subsequent nasal surgery

    - Change from baseline in the NPSQ [Nasal polyposis symptoms questionnaire]

    - Change from baseline in DSS [Difficulty with sense of smell]

    - Change from baseline in the UPSIT [University of Pennsylvania Smell Identification Test]

    - Change from baseline in the SF-36v2 [Short Form 36-item Health survey, Version 2]

    - Change from baseline in Lund Mackay score and sinus severity score by Quantitative CT analysis

    - AEs, vital signs, and clinical laboratory values

    - Assessments related to AEs [adverse events] cover

    - Vital signs parameters include systolic and diastolic blood pressure, and pulse, as well as respiration rate and body temperature. Assessments related to vital signs cover: observed value, absolute and percent change from baseline values over time

    - Serum PK

    - Benralizumab ADA
    E.5.2.1Timepoint(s) of evaluation of this end point
    through the end of the treatment period
    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 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 EEA30
    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
    The end of study will occur when the required number of primary and key secondary endpoint events have been observed. Participants will be followed for a minimum of 56-week double-blind treatment, up to a maximum of 104 weeks in order to accrue an adequate number of events for the primary endpoint and the key secondary endpoint.
    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 months
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial days10
    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: 175
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state154
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 154
    F.4.2.2In the whole clinical trial 200
    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 Decision2020-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-03-12
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