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    Summary
    EudraCT Number:2019-002871-32
    Sponsor's Protocol Code Number:D3255C00001
    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:2020-03-18
    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 number2019-002871-32
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Benralizumab in Patients with Eosinophilic Esophagitis
    A.3.2Name or abbreviated title of the trial where available
    MESSINA
    A.4.1Sponsor's protocol code numberD3255C00001
    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 sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZenecaAB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZenecaAB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post codeSE-151 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 typeequal
    D.3.10.3Concentration numberDose 1
    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
    Eosinophilic Esophagitis (EoE)
    E.1.1.1Medical condition in easily understood language
    Eosinophilic Esophagitis (EoE)
    Allergic Esophagitis
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10064220
    E.1.2Term Eosinophilic esophagitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of benralizumab Dose Regimen 1 on histologic signs and symptoms of EoE in patients with symptomatic and histologically active EoE.
    E.2.2Secondary objectives of the trial
    DB treatment period:
    -To evaluate the effect of benralizumab Dose Regimen 1 on clinical features of EoE and disease activity.
    -To evaluate the effect of benralizumab Dose Regimen 1 on patient reported QOL measures.
    -To evaluate the effect of benralizumab Dose Regimen 1 on healthcare resource utilization due to EoE.
    -To evaluate the effect of benralizumab Dose Regimen 1 on patient reported measures of disease severity and health status.
    -To assess the PK and immunogenicity of benralizumab Dose Regimen 1 in patients with EoE.
    -To assess the safety and tolerability of benralizumab Dose Regimen 1 in patients with EoE.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. EndoFLIP (Endolumenal Functional Lumen Imaging Probe)
    Objective: To evaluate the effect of benralizumab Dose Regimen 1 on clinical features of EoE and disease activity.
    2. Qualitative Interview Sub-study.
    Objective:To characterize the health-related quality of life impact of EoE and of study treatment.
    E.3Principal inclusion criteria
    - Patients 12 to 65 years of age, inclusive, at the time of signing the informed consent or assent (if applicable) form.
    -Documented previous diagnosis of EoE by endoscopy (documented diagnosis defined as an esophageal count of ≥15 eos/hpf on at least 1 esophageal level) and confirmed diagnosis by a centrally-read esophageal biopsy for the purposes of this study (confirmed diagnosis defined as an esophageal count of ≥15 eos/hpf at 2 or more esophageal levels).
    Two to 4 biopsies should be obtained from both the proximal and distal esophagus.
    Biopsies can be taken from the mid-esophagus for additional evaluation.
    -Must be symptomatic at Visit 1 (screening) and Visit 2 (randomization):
    (a) A patient reported average of at least 2 days per week with an episode of dysphagia over the 4 weeks prior to Visit 1 AND
    (b) At least 2 days with an episode of dysphagia (Daily DSQ ≥2) between Visit 1 and Visit 2.
    -Must be adherent to daily diary assessments:
    (a) Must complete 70% of daily diaries between Visit 1 and Visit 2; AND
    (b) Must have completed at least 8 of 14 daily diaries in the 14 days prior to randomization.
    -May be on background medications for EoE and related treatments during the study as long as the background medications have been stable for at least 4 weeks (8 weeks for PPI) prior to screening.
    -Negative serum pregnancy test for female patients of childbearing potential at Visit1.
    -Women of childbearing potential must agree to use a highly effective form of birth control (confirmed by the Investigator) from randomization throughout the study duration and within 16 weeks after last dose if IP.
    E.4Principal exclusion criteria
    -Other GI disorders such as active Helicobacter pylori infection, history of achalasia,
    esophageal varices, Crohn’s disease, ulcerative colitis, inflammatory bowel disease, or
    celiac disease.
    -Esophageal stricture that prevents the easy passage of a standard endoscope or any critical
    esophageal stricture that requires dilation during the run-in period.
    -Esophageal dilation performed within 8 weeks prior to screening.
    -Use of a feeding tube, or not eating solid food daily during the run-in period.
    -Hypereosinophilic syndrome, defined by multiple organ involvement and persistent blood
    eosinophil count >1500 eos/μL.
    -EGPA vasculitis.
    -Eosinophilic gastritis, gastroenteritis, enteritis, or colitis documented by biopsy.
    -Current malignancy, or history of malignancy with some specific exceptions.
    - History of anaphylaxis to any biologic therapy or vaccine.
    - Current active liver disease:
    *Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen
    [HBsAg] or hepatitis C antibody), or other stable chronic liver disease are acceptable if patient otherwise meets eligibility criteria.
    *Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3 times the
    upper limit of normal (ULN), confirmed by repeated testing during the run-in period.
    -Helminth parasitic infection diagnosed within 24 weeks prior to the date informed
    consent or assent (if applicable) is obtained that has not been treated with or has failed to
    respond to standard of care therapy.
    -History of known immunodeficiency disorder including a positive human
    immunodeficiency virus (HIV) test.
    -Concomitant use of immunosuppressive medication.
    -Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to start of the run-in period.
    -Currently pregnant, breastfeeding, or lactating women.
    E.5 End points
    E.5.1Primary end point(s)
    Dual-primary Endpoints:
    -Proportion of patients with a histologic response at Week 24, defined as a peak esophageal
    intraepithelial eosinophil count ≤ 6 eos/hpf
    - Changes from baseline in DSQ score at Week 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Both at Week 24
    E.5.2Secondary end point(s)
    Study Objectives for the DB treatment period:
    -Key secondary endpoint: Changes from baseline in centrally-read EoE EREFS at Week 24
    -Centrally-read biopsies for additional histopathology and tissue eosinophil counts,
    including EoE-HSS, at Week 24
    -Dysphagia-free days as captured by the DSQ
    -Frequency of dysphagia episodes as captured by the EoE-3D
    -Changes from baseline in dysphagia associated pain, discomfort, and overall severity as captured by the EoE-3D at Week 24
    -Changes from baseline in abdominal pain and nausea as captured by the daily diary at Week 24
    -Changes from baseline in EoE-QoL-A at Week 24
    -SF-36 v2 Health Survey at Week 24
    - Percent of patients with relevant concomitant procedures and healthcare resource utilization during the study through Week 24
    -PGI-S at Week 24
    - PGI-C at Week 24
    -Serum benralizumab concentration
    -ADA and nAb
    -Safety and tolerability will be evaluated in terms of AEs, Vital signs, and Clinical laboratory values
    E.5.2.1Timepoint(s) of evaluation of this end point
    Varies depending on the endpoint/objective
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Samples collected for the Genomics Initiative are considered primary use and will be whole exome or whole genome sequenced. Analysis will be performed for both known and novel health related genes and this broad genetic research will not restrict to disease or drug. Sequencing data generated is for research purposes only and cannot be used for clinical decision making and there will not be any clinical endpoints delivered to the study, as a result of testing performed.
    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
    Following DB treatment ,patients continue with Open Label benralizumab Dosing Regimen1 to Week 52
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Netherlands
    Poland
    Russian Federation
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 is defined as the 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 years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days27
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 40
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 130
    F.1.3Elderly (>=65 years) No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 107
    F.4.2.2In the whole clinical trial 170
    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)
    Upon completion of the initial 52-week treatment period, patients will be invited to an additional 52-week Open Label Extension of benralizumab Dosing Regimen 1 for another 52 weeks, with ongoing study assessments. After completion of the study, patients will exit the trial and will return to care under their clinician’s direction.
    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 Decision2020-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-24
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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