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    Summary
    EudraCT Number:2021-000085-14
    Sponsor's Protocol Code Number:D3258C00001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-27
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-000085-14
    A.3Full title of the trial
    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 (The HUDSON GI Study)
    Studio di fase 3, multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo, in 3 parti per dimostrare l’efficacia e la sicurezza di benralizumab in pazienti affetti da gastrite e/o gastroenterite eosinofila (HUDSON GI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
    Efficacia e sicurezza di benralizumab in pazienti con gastrite e/o gastroenterite eosinofila (HUDSON GI)
    A.3.2Name or abbreviated title of the trial where available
    HUDSON GI
    HUDSON GI
    A.4.1Sponsor's protocol code numberD3258C00001
    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 support
    B.4.2Country
    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 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 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 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 typenot less then
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Gastritis and/or Gastroenteritis (EG/EGE).
    Gastrite e/o gastroenterite eosinofile (EG/EGE).
    E.1.1.1Medical condition in easily understood language
    EG/EGE are inflammatory disorders characterized by eosinophilic infiltration of the stomach and/or duodenum with a burden of gastrointestinal symptoms (eg, abdominal pain, nausea, and bloating)
    EG/EGE sono disturbi infiammatori caratterizzati da infiltrazione eosinofila dello stomaco e/o del duodeno con un carico di sintomi gastrointestinali (es. dolore addominale, nausea e gonfiore)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    PartA/B: To compare the effect of benralizumab with placebo on histologic signs and gastrointestinal symptoms in patients with eosinophilic gastritis and/or gastroenteritis
    Parte A/B: Confrontare l’effetto di benralizumab, rispetto al placebo, sui segni istologici e sui sintomi gastrointestinali in pazienti con gastrite e/o gastroenterite eosinofila.
    E.2.2Secondary objectives of the trial
    -Part A/B: To compare the effect of benralizumab with placebo on clinical features of eosinophilic gastritis/ gastroenteritis and disease activity.
    -Part A/B: To compare the effect of benralizumab with placebo on rescue corticosteroid use.
    -Part A/B: To compare the effect of benralizumab with placebo on health-related quality of life in patients with EG/EGE.
    -To assess the pharmacokinetics and immunogenicity of benralizumab in patients with EG/EGE.
    -To assess the safety of benralizumab in patients with eosinophilic gastritis and/or gastroenteritis.
    • Parte A/B: confrontare l’effetto di benralizumab, rispetto al placebo, sulle caratteristiche cliniche della gastrite/gastroenterite eosinofila e sull’attività della malattia
    • Parte A/B: confrontare l’effetto di benralizumab, rispetto al placebo, sull’uso di corticosteroidi di soccorso
    • Parte A/B: confrontare l’effetto di benralizumab, rispetto al placebo, sulla qualità della vita (QoL) correlata alla salute in pazienti con EG/EGE
    • Valutare la farmacocinetica e l’immunogenicità di benralizumab in pazienti affetti da EG/EGE
    • Valutare la sicurezza di benralizumab in pazienti con gastrite e/o gastroenterite eosinofila
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: To characterize the patient experience of EG/EGE and its treatments.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Caratterizzare l'esperienza del paziente con EG/EGE e i suoi trattamenti
    E.3Principal inclusion criteria
    · Aged >= 12 years of age at the time of signing the ICF or informed consent or assent form.
    · Confirmed diagnosis of EG/EGE for at least 3 months prior to screening.
    · Baseline Eosinophilic gastritis, with or without duodenitis, or eosinophilic duodenitis alone confirmed by biopsy
    with a gastric count of =30 eosinophils/hpf in at least 5 hpfs and/or duodenal eosinophil count =30 eosinophils/hpf in at least 3 hpfs without any other cause for the gastrointestinal eosinophilia.
    · Symptoms including at least moderate abdominal pain, nausea, bloating, early satiety, and/or loss of appetite
    · Must be adherent to daily PRO assessments including at least 8 of 14 symptom assessments in the 14 days prior to randomization
    · If on background medications for EG/EGE, the medications should be stable at least 4 weeks prior to the run-in period.
    · Willing and able to comply with all study procedures and visit schedule including follow-up visits
    · 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 12 weeks after last dose if IP.
    • Età = 12 anni al momento della firma dell’ICF o del consenso informato o del modulo d’assenso
    • Diagnosi di EG/EGE confermata per almeno 3 mesi prima dello screening.
    • Gastrite eosinofila basale, in presenza o assenza di duodenite, o sola duodenite eosinofila, confermata da biopsia con una conta a livello gastrico = 30 eosinofili per campo ad alto ingrandimento [hpf] in almeno 5 hpf e/o conta eosinofila a livello duodenale = 30 eosinofili/hpf in almeno 3 hpf, senza alcuna altra causa di eosinofilia gastrointestinale.
    • Sintomi che includano almeno: moderato dolore addominale, nausea, gonfiore, sazietà e/o perdita d’appetito. Bisogna essere conformi alle valutazioni giornaliere PRO, incluse le valutazioni di almeno 8 dei 14 sintomi, nei 14 giorni precedenti la randomizzazione.
    • Se è in corso il trattamento di EG/EGE con farmaci di base, i farmaci devono restare invariati per almeno 4 settimane prima dell’arruolamento.
    • Intenzione e disponibilità a rispettare tutte le procedure dello studio e il calendario delle visite, incluse le visite di follow up.
    • Le donne in età fertile devono accettare l’utilizzo di una forma altamente efficace di controllo delle nascite (confermato dallo sperimentatore) per tutta la durata dello studio, a partire dalla randomizzazione, ed entro 12 settimane dopo l’ultima dose di IP.
    E.4Principal exclusion criteria
    · Other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, or celiac disease.
    · Hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis.
    · Current malignancy, or history of malignancy, except for patients who have had basal
    cell, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are
    eligible provided that the patient is in remission and curative therapy was completed at
    least 12 months prior to the date of informed consent.
    · History of anaphylaxis to any biologic therapy or vaccine.
    · Current active liver disease.
    · Helminth parasitic infection diagnosed within 24 weeks prior to the date informed that has not been treated with or has failed to respond to standard of care therapy.
    · Known immunodeficiency disorder including testing positive for HIV.
    · Concomitant use of immunosuppressive medication.
    · Receipt of live attenuated vaccines 30 days prior to date of informed consent or assent.
    · Receipt of inactive vaccines within 7 days of informed consent or assent.
    · Initiation or change of a food-elimination diet regimen or re-introduction of a previously
    eliminated food group from 6 weeks prior to start of the run-in period and unable or
    unwilling to remain on a stable diet until the completion of Week 52.
    · Currently pregnant or breast-feeding.
    • Altri disordini gastrointestinali, come infezione da Helicobacter pylori attiva, storia pregressa di acalasia, varici esofagee, morbo di Crohn, colite ulcerosa, malattia infiammatoria a carico dell’intestino o celiachia.
    • Sindrome ipereosinofila o granulomatosi eosinofila con poliangiite.
    • Neoplasia maligna in corso o pregressa, ad eccezioni di pazienti che hanno avuto carcinoma a cellule basali, carcinoma localizzato della pelle a cellule squamose o carcinoma della cervice in situ, che sono elegibili a condizione che il paziente sia in remissione e che la terapia sia stata completata almeno 12 mesi prima della data del consenso informato.
    • Storia pregressa di anafilassi a qualsiasi terapia biologica o vaccino.
    • Patologia epatica attiva in corso.
    • Infezione parassitaria da elminti, diagnosticata entro 24 settimane prima della data del consenso informato, che non è stata trattata o che non ha risposto alla terapia standard.
    • Disordine da immunodeficienza noto, compresa la positività all’HIV.
    • Uso concomitante di farmaci immunosoppressivi.
    • Somministrazione di vaccini vivi attenuati 30 giorni prima della data del consenso informato o assenso.
    • Somministrazione di vaccini inattivati entro 7 giorni dal consenso informato o assenso.
    • Inizio o modifica di una dieta per l’eliminazione di un gruppo alimentare o la reintroduzione di un gruppo alimentare precedentemente eliminato, da 6 settimane prima dell’arruolamento, con incapacità o inabilità di seguire una dieta stabile fino alla fine della settimana 52.
    • Attualmente in gravidanza o in allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    Dual primary endpoints
    1). Proportion of patients achieving a histological response in the stomach and/or in the duodenum
    Histologic Endpoint:defined as =6 eosinophils/high power field (hpf) in the stomach and/or, =15 eosinophils/hpf in the duodenum at Week 24
    2). Absolute change in symptoms of EG/EGE
    Doppio end point primario.
    1) Percentuale di pazienti che ottengono una risposta istologica a livello gastrico o duodenale. Endpoint istologico: definito come eosinofili per campo ad alto ingrandimento [HPF] =6 nello stomaco e/o eosinofili per HPF =15 nel duodeno alla Settimana 24.
    2) Variazione assoluta dei sintomi di EG/EGE
    E.5.1.1Timepoint(s) of evaluation of this end point
    Both at Week 24
    Entrambi alla settimana 24.
    E.5.2Secondary end point(s)
    Tissue eosinophilis -Percentage change from baseline in tissue eosinophils (stomach and/or duodenum if applicable) at Week 24
    Treatment response -Proportion of patients who achieve treatment response: tissue remission (= 6 eosinophils/hpf in the stomach and = 15 eosinophils/hpf in the duodenum, if applicable) and an improvement in symptoms at Week 24
    Diarrhea-free days - Change from baseline in proportion of diarrhea-free days, and change from baseline in frequency of diarrhea episodes at Week 24
    Vomiting-free days - Change from baseline in proportion of vomiting-free days, and change from baseline in frequency of vomiting episodes at Week 24
    To compare the effect of benralizumab with placebo on rescue use - Proportion of patients with no rescue corticosteroid use up to Week 24
    To evaluate the effect of benralizumab on patient reported QOL measures at Week 24
    Safety and tolerability - Safety and tolerability will be evaluated in terms of adverse events, vital signs, physical exam, and clinical laboratory parameters at Week 52
    • Eosinofilia tissutale: variazione percentuale rispetto al basale negli eosinofili tissutali (stomaco e/o duodeno ove applicabile) alla Settimana 24.
    • Risposta al trattamento: percentuale di pazienti che ottengono una risposta al trattamento: remissione tissutale (eosinofili/HPF =6 nello stomaco e/o eosinofili/HPF =15 nel duodeno, ove applicabile) e un miglioramento dei sintomi alla Settimana 24
    • Giorni senza diarrea: variazione rispetto al basale nella percentuale di giorni senza diarrea e variazione rispetto al basale nella frequenza degli episodi di diarrea alla settimana 24.
    • Confrontare l’effetto di benralizumab rispetto al placebo sull’uso di farmaci di soccorso: percentuale di pazienti che non fanno uso di corticosteroidi di soccorso fino alla Settimana 24.
    • Confrontare l’effetto di benralizumab rispetto al placebo sulla qualità della vita (QoL) correlata alla salute in pazienti con EG/EGE alla settimana 24.
    • Sicurezza e tollerabilità: la sicurezza e la tollerabilità saranno valutate in termini di eventi avversi, segni vitali e parametri clinici di laboratorio alla settimana 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Depending on the endpoints/objective
    Dipende dall'end point/obiettivo.
    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
    Optional genetic research
    Ricerca genetica opzionale
    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
    Trattamento DB seguito da almeno un anno OLE, a partire dalla settimana 24
    DB treatment followed by at least 1 year OLE starting at week 24
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    China
    Japan
    Ukraine
    United States
    Vietnam
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Switzerland
    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.
    La fine dello studio è definita come l'ultima visita/contatto programmata per l'ultimo paziente sottoposto allo studio.
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 169
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 88
    F.4.2.2In the whole clinical trial 230
    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)
    After completion of the study, patients will exit the trial and will return to care under their clinician’s direction
    Dopo il completamento dello studio, i pazienti usciranno dalla sperimentazione e torneranno
    in cura sotto la direzione del proprio medico
    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 Decision2021-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-08
    P. End of Trial
    P.End of Trial StatusOngoing
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