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    Clinical Trial Results:
    A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis

    Summary
    EudraCT number
    		 2021-000085-14
    Trial protocol
    		 DE   ES   NL   PL   IT   FR   BE  
    Global end of trial date
    13 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Aug 2024
    First version publication date
    18 Aug 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D3258C00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05251909
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca KK
    Sponsor organisation address
    3-1 Ofuka-cho, Kita-ku,, Osaka, Japan, 530-011
    Public contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    151 85, Södertälje, Sweden,
    Public contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Jun 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Feb 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the effect of benralizumab 30 mg every 4 weeks (Q4W) with placebo on histologic signs and gastrointestinal symptoms in patients with eosinophilic gastritis and/or gastroenteritis
    Protection of trial subjects
    Participants’ confidentiality and personal information will be protected throughout the study to the same standard as all other coded data in the study.
    Background therapy
    		 Medications for EG/EGE (eg, systemic and topical ingested or swallowed corticosteroids, PPIs) and steroid treatments used for asthma or allergies that are inhaled or administered intranasally
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jan 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 2
    Country: Number of subjects enrolled
    United States: 9
    Country: Number of subjects enrolled
    Italy: 1
    Worldwide total number of subjects
    12
    EEA total number of subjects
    1
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    1
    Adults (18-64 years)
    9
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients ages 12 and above with EG/EGE that are symptomatic and histologically active on stable background medication and diet

    Pre-assignment
    Screening details
    		 The study had a 4-8 week screening period

    Period 1
    Period 1 title
    Double Blind
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Carer, Data analyst, Assessor, Monitor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Benralizumab
    Arm description
    		 Patients received benralizumab every 4 weeks for the 24 weeks treatment period
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benralizumab
    Investigational medicinal product code
    MEDI-563
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Benralizumab 30mg SC injection was administered Q4W

    Arm title
    		 Placebo
    Arm description
    		 Patients received matching Placebo every 4 weeks for the 24 weeks treatment period
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30 mg every 4 weeks

    Number of subjects in period 1
    		Benralizumab Placebo
    Started
    6
    6
    Completed
    6
    3
    Not completed
    0
    3
         Consent withdrawn by subject
    -
    3
    Period 2
    Period 2 title
    OLE Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Benralizumab
    Arm description
    		 Open label Benralizumab 30mg q4 weekly
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benralizumab
    Investigational medicinal product code
    MEDI-563
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Benralizumab 30mg SC injection was administered Q4W

    Number of subjects in period 2
    		Benralizumab
    Started
    9
    Completed
    7
    Not completed
    2
         Consent withdrawn by subject
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Benralizumab
    Reporting group description
    		 Patients received benralizumab every 4 weeks for the 24 weeks treatment period

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received matching Placebo every 4 weeks for the 24 weeks treatment period

    Reporting group values
    		 Benralizumab Placebo Total
    Number of subjects
    		 6 6 12
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 1 1
        Adults (18-64 years)
    		 5 4 9
        From 65-84 years
    		 1 1 2
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 51.17 (39 to 68) 39.17 (17 to 72) -
    Gender Categorical
    Units: Subjects
        Female
    		 5 1 6
        Male
    		 1 5 6
    Race
    Units: Subjects
        White
    		 5 3 8
        Asian
    		 1 1 2
        Black or African American
    		 0 1 1
        Other
    		 0 1 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic of Latino
    		 6 6 12
    Subject analysis sets

    Subject analysis set title
    Benralizumab
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients received benralizumab 30mg every 4 weeks for the 24 weeks treatment period

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients received matching Placebo every 4 weeks for the 24 weeks treatment period

    Subject analysis sets values
    		 Benralizumab Placebo
    Number of subjects
    6
    6
    Age Categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    1
        Adults (18-64 years)
    5
    4
        From 65-84 years
    1
    1
        85 years and over
    0
    0
    Age Continuous
    Units: years
        arithmetic mean (full range (min-max))
    51.17 (39 to 68)
    39.17 (17 to 72)
    Gender Categorical
    Units: Subjects
        Female
    5
    1
        Male
    1
    5
    Race
    Units: Subjects
        White
    5
    3
        Asian
    1
    1
        Black or African American
    0
    1
        Other
    0
    1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0
    0
        Not Hispanic of Latino
    6
    6

    End points

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    End points reporting groups
    Reporting group title
    Benralizumab
    Reporting group description
    		 Patients received benralizumab every 4 weeks for the 24 weeks treatment period

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received matching Placebo every 4 weeks for the 24 weeks treatment period
    Reporting group title
    Benralizumab
    Reporting group description
    		 Open label Benralizumab 30mg q4 weekly

    Subject analysis set title
    Benralizumab
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients received benralizumab 30mg every 4 weeks for the 24 weeks treatment period

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients received matching Placebo every 4 weeks for the 24 weeks treatment period

    Primary: Proportion of patients with a histologic response at Week 24

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    End point title
    		 Proportion of patients with a histologic response at Week 24 [1]
    End point description
    For the first primary endpoint, the proportion of patients achieving a histological response at Week 24, is defined as below: ≤6 eosinophils/hpf in the stomach for the patients with only gastric disease at baseline. ≤6 eosinophils/hpf in the stomach and ≤15 eosinophils/hpf in the duodenum for the patients with gastric + duodenal disease at baseline. ≤15 eosinophils/hpf in the duodenum for the patients with only duodenal disease at baseline.
    End point type
    Primary
    End point timeframe
    at week 24
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No analysis was performed due to study termination prior to sufficient patient randomization.
    End point values
    		 Benralizumab Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: percentage
    Notes
    [2] - No analysis was performed due to study termination prior to sufficient patient randomization.
    [3] - No analysis was performed due to study termination prior to sufficient patient randomization.
    No statistical analyses for this end point

    Primary: CFB in SAGED score at Week 24

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    End point title
    		 CFB in SAGED score at Week 24 [4]
    End point description
    The Symptom Assessment for Gastrointestinal Eosinophilic Diseases (SAGED) instrument was developed to measure gastrointestinal symptoms in participants diagnosed with EG/EGE. The SAGED instrument, comprising 8 items, measures the severity of abdominal pain, nausea, bloating, early satiety, lack of appetite, vomiting, diarrhea, and frequency of vomiting. Severity for each concept is assessed using an 11-point numerical rating scale (where 0 = ‘none’ and 10 = ‘worst imaginable’). Frequency of vomiting is reported as number of episodes of vomiting within the past 24 hours.
    End point type
    Primary
    End point timeframe
    at week 24
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No analysis was performed due to study termination prior to sufficient patient randomization.
    End point values
    		 Benralizumab Placebo
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: score
    Notes
    [5] - No analysis was performed due to study termination prior to sufficient patient randomization.
    [6] - No analysis was performed due to study termination prior to sufficient patient randomization.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are reported from the first dose administration up to 30 days after the last dose of study drug.
    Adverse event reporting additional description
    The Safety Analysis Set included all participants who received at least 1 dose of study drug
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Benra 30 mg
    Reporting group description
    		 Patients received benralizumab 30mg every 4 weeks for the 24 weeks treatment period.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received matching Placebo every 4 weeks for the 24 weeks treatment period

    Serious adverse events
    		 Benra 30 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Benra 30 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    3 / 6 (50.00%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Injection site reaction
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Menstrual discomfort
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Eating disorder
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Foot fracture
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Eosinophilia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Myopic chorioretinal degeneration
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    Abdominal pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 6 (16.67%)
         occurrences all number
    2
    1
    Diarrhoea
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Arthritis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Pain in extremity
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Bronchitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Bacterial infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Fungal infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Parotitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Sialoadenitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Tooth abscess
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Genitourinary tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Mar 2023
    This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union. Following the decision to close recruitment to this study early, the primary rationale for this amendment is to fulfill a commitment to participants as they enrolled in the trial, of open-label access to benralizumab following double-blind treatment. This amendment will make available a streamlined 24-week open-label trial of benralizumab with the addition of a Part D, contingent on the Investigator's clinical judgement and the potential for benefit.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to early termination of study limited number of patients was randomized and thus data was not analysed on group level.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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