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    Summary
    EudraCT Number:2021-000085-14
    Sponsor's Protocol Code Number:D3258C00001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-11
    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 ConcernedSpain - AEMPS
    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)
    Ensayo de fase 3 de 3 partes, multicéntrico, aleatorizado, doble ciego, de grupos paralelos, controlado con placebo para demostrar la eficacia y seguridad de Benralizumab en pacientes con Gastritis y/o Gastroenteritis eosinofílica (ensayo 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)
    Eficacia y seguridad de Benralizumab en pacientes con Gastritis y/o Gastroenteritis eosinofílica (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 Yes
    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 Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56; Parque Norte, Ed. Álamo
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900200444
    B.5.6E-mailinformacionEECC-Spain@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 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
    Eosinophilic Gastritis and/or Gastroenteritis
    Gastritis y/o Gastroenteritis eosinofílica
    E.1.1.1Medical condition in easily understood language
    Eosinophilic Gastritis and/or Gastroenteritis
    Gastritis y/o Gastroenteritis eosinofílica
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10083619
    E.1.2Term Eosinophilic gastritis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10017902
    E.1.2Term Gastroenteritis eosinophilic
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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: comparar el efecto benralizumab con placebo sobre los signos histológicos y los síntomas gastrointestinales en pacientes con gastritis y/o gastroenteritis eosinofílica.
    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: Comparar el efectosde benralizumab con placebo sobre las características clínicas de la gastritis/gastroenteritis eosinofílica y la actividad de la enfermedad.
    - Parte A/B: Comparar el efecto de benralizumab con placebo en el uso de corticoides como medicación de rescate.
    - Parte A/B: Comparar el efecto de benralizumab con placebo sobre la calidad de vida relacionada en pacientes con EG/EGE.
    - Evaluar la farmacocinética e inmunogenicidad de benralizumab e apcientes con EG/EGE.
    - Evaluar la seguridad de benralizumab en pacientes con gastritis y/o gastroenteritis eosinofílica
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To characterize the patient experience of EG/EGE and its treatments.
    Caracterizar la experiencia del paciente con EG/EGE y sus tratamientos.
    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.
    • Edad >=12 años en el momento de firmar el FCI o consentimiento informado o formulario de conformidad.
    • Diagnóstico confirmado de GE/GEE durante al menos 3 meses antes de la selección.
    • Gastritis eosinofílica basal, con o sin duodenitis, o duodenitis eosinofílica sola confirmada por biopsia con un recuento gástrico de ≥30 eosinófilos/CGA en al menos 5 CGA o recuento de eosinófilos duodenales de ≥30 eosinófilos/CGA en al menos 3 CGA sin ninguna otra causa para la eosinofilia gastrointestinal.
    • Síntomas que incluyen al menos dolor abdominal moderado, náuseas, hinchazón, saciedad temprana o pérdida del apetito
    • Debe cumplir con las evaluaciones RCP diarias, incluidas al menos 8 de 14 evaluaciones de síntomas en los 14 días anteriores a la aleatorización
    • Si está tomando medicamentos de base para GE/GEE, la medicación debe ser estable al menos 4 semanas antes del periodo de reclutamiento.
    • Dispuesto y capaz de cumplir con todos los procedimientos del ensayo y el programa de visitas, incluidas las visitas de seguimiento
    • Las mujeres en edad fértil deben aceptar el uso de un método anticonceptivo altamente eficaz (confirmado por el investigador) desde la aleatorización, durante la duración del estudio y en las 12 semanas posteriores a la última dosis si padece PI.
    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.
    • Otros trastornos gastrointestinales como infección activa por Helicobacter pylori, antecedentes de acalasia, várices esofágicas, enfermedad de Crohn, colitis ulcerosa, enfermedad intestinal inflamatoria o celiaquía.
    • Síndrome hipereosinofílico o granulomatosis eosinofílica con poliangitis.
    • Neoplasia maligna actual o antecedentes de neoplasia maligna, excepto en el caso de pacientes que hayan tenido carcinoma de células basales, carcinoma de células escamosas localizado de la piel o carcinoma in situ del cuello uterino, son elegibles siempre que el paciente esté en remisión y se haya completado el tratamiento curativo al menos 12 meses antes de la fecha del consentimiento informado.
    • Antecedentes de anafilaxia a cualquier tratamiento biológico o vacuna.
    • Enfermedad hepática activa actual.
    • Infección parasitaria por helmintos diagnosticada en las 24 semanas anteriores a la fecha informada, que no se ha tratado o no ha respondido al tratamiento de referencia.
    • Trastorno de inmunodeficiencia conocido que incluye pruebas positivas para el VIH.
    • Uso de medicamentos inmunodepresores simultáneos.
    • Recepción de vacunas vivas atenuadas 30 días antes de la fecha del consentimiento informado o conformidad.
    • Recepción de vacunas inactivas en los 7 días posteriores al consentimiento informado o conformidad.
    • Inicio o cambio de un régimen dietario de eliminación de alimentos o reintroducción de un grupo de alimentos previamente eliminado en las 6 semanas anteriores al inicio del periodo de reclutamiento y no puede o no quiere permanecer en una dieta estable hasta completar la semana 52.
    • Embarazada o en periodo de lactancia en la actualidad.
    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
    Criterios de valoración principales dobles
    1). Proporción de pacientes que lograron una respuesta histológica en el estómago o en el duodeno
    Criterio de valoración histológico: definido como ≤6 eosinófilos/campo de gran aumento (CGA) en el estómago o ≤15 eosinófilos/CGA en el duodeno en la semana 24
    2). Cambio absoluto en los síntomas de GE/GEE
    E.5.1.1Timepoint(s) of evaluation of this end point
    Both at Week 24
    Ambos a la semana 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
    Eosinófilos tisulares: variación porcentual respecto al inicio en los eosinófilos tisulares (estómago o duodeno según sea aplicable) en la semana 24
    Respuesta al tratamiento: proporción de pacientes que logran una respuesta al tratamiento: remisión tisular (≤6 eosinófilos/CGA en el estómago y ≤15 eosinófilos/CGA en el duodeno) y una mejoría de los síntomas en la semana 24
    Días sin diarrea: variación respecto al inicio en la proporción de días sin diarrea y variación respecto al inicio en la frecuencia de episodios de diarrea en la semana 24
    Días sin vómitos: variación respecto al inicio en la proporción de días sin vómitos y variación respecto al inicio en la frecuencia de episodios de vómitos en la semana 24
    Comparar el efecto de benralizumab con placebo sobre el uso de rescate: proporción de pacientes sin uso de corticoides de rescate hasta la semana 24
    Evaluar el efecto de benralizumab en las medidas de calidad de vida comunicadas por el paciente en la semana 24
    Toxicidad y tolerabilidad: la toxicidad y la tolerabilidad se evaluarán en términos de acontecimientos adversos, constantes vitales, exploración física y parámetros de laboratorio clínico en la semana 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Depending on the endpoints/objective
    Dependiendo de los criterios de evaluación/objetivos
    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
    Investigación genética opcional
    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
    Tto doble ciego seguido de 1 año al menos para iniciar estudio de extensión en abierto en semana 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 concerned3
    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 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
    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.
    El fin del estudio se define como la última visita/contacto esperado del último paciente en el estudio.
    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 days7
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    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: 60
    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 state31
    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
    Tras la finalización del estudio, los pacientes saldrán del ensayo y volverán a ser atendidos bajo la dirección de sus médicos.
    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 Decision2021-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-24
    P. End of Trial
    P.End of Trial StatusOngoing
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