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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-001294-31
    Sponsor's Protocol Code Number:D5244C00001
    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:2022-09-19
    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 number2022-001294-31
    A.3Full title of the trial
    A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients with Eosinophilic Esophagitis (CROSSING)
    Ensayo de fase III aleatorizado, doble ciego, de grupos paralelos, controlado con placebo, para evaluar la eficacia y seguridad de Tezepelumab en pacientes con Esofagitis Eosinofílica (CROSSING)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Tezepelumab in Patients with Eosinophilic Esophagitis
    Eficacia y seguridad de Tezepelumab en pacientes con Esofagitis Eosinofílica
    A.3.2Name or abbreviated title of the trial where available
    CROSSING
    A.4.1Sponsor's protocol code numberD5244C00001
    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 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 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 nameTezepelumab via APFS
    D.3.2Product code MEDI9929 anti-TSLP mAb (AMG157)
    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 INNTezepelumab
    D.3.9.1CAS number 1572943-04-4
    D.3.9.2Current sponsor codeMEDI9929
    D.3.9.3Other descriptive nameAMG 157
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number99 to 121
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    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) is a rare, chronic inflammatory disorder triggered by an immune response to foods and aeroantigens and characterized by a combination of esophageal dysfunction and eosinophilic infiltration of the esophagus
    La esofagitis eosinofílica (EoE) es un trastorno inflamatorio crónico raro desencadenado por una respuesta inmunitaria a los alimentos y aeroantígenos y caracterizado por una combinación de disfunción esofágica e infiltración eosinofílica del esófago.
    E.1.1.1Medical condition in easily understood language
    Eosinophilic esophagitis (EoE)
    Allergic Esophagitis
    Esofagitis eosinofílica (EoE)
    Esofagitis alérgica
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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
    1. To evaluate the effect of tezepelumab on the histologic response in adult and adolescent participants with symptomatic and histologically active EoE
    2. To evaluate the effect of tezepelumab on symptom improvement in adult and adolescent participants with symptomatic and histologically active EoE
    1. Evaluar el efecto de tezepelumab sobre la respuesta histológica en participantes adultos y adolescentes con EoE sintomática e
    histológicamente activa.
    2. Evaluar el efecto de tezepelumab sobre la mejoría de los síntomas en participantes adultos y adolescentes con EoE sintomática e
    histológicamente activa.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of tezepelumab on the centrally-read EoE EREFS
    2. To evaluate the effect of tezepelumab on the centrally-read EoE-HSS
    3. To evaluate the long-term effect of tezepelumab on the histologic response
    4. To evaluate the long-term effect of tezepelumab on symptom improvement
    5. To evaluate the long-term effect of tezepelumab on the centrally-read EoE EREFS
    6. To evaluate the effect of tezepelumab on achievement of clinico-histological remission
    7. To evaluate the effect of tezepelumab on peak eosinophil count
    8. To evaluate the effect of tezepelumab on EoE symptoms in adolescents
    9. To evaluate the long-term effect of tezepelumab
    1. Evaluar el efecto de tezepelumab sobre la EREFS de la EoE de lectura centralizada.
    2. Evaluar el efecto de tezepelumab sobre el EoE-HSS de lectura centralizada.
    3. Evaluar el efecto a largo plazo de tezepelumab sobre la respuesta histológica.
    4. Evaluar el efecto a largo plazo de tezepelumab sobre la mejoría de los síntomas.
    5. Evaluar el efecto a largo plazo de tezepelumab en la EREFS de la EoE de lectura centralizada.
    6. Evaluar el efecto de tezepelumab sobre el logro de la remisión clínico-histológica.
    7. Evaluar el efecto de tezepelumab sobre el recuento máximo de eosinófilos.
    8. Evaluar el efecto de tezepelumab sobre los síntomas de la EoE en adolescentes.
    9. Evaluar el efecto a largo plazo de tezepelumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be 12 to 80 years of age inclusive, at the time of signing the informed consent/assent.

    2. Weight ≥ 40 kg at Visit 1

    3. Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming a diagnosis of EoE.

    4. Participants who have symptomatic EoE as defined by a history of on average at least 2 episodes of dysphagia (any severity of food going down slowly or being stuck in the throat) per week in the 4 weeks prior to Visit 1.

    5. Must remain on a stabilized diet for at least 8 weeks prior to Visit 1 and during the course of the study (stable diet is defined as no initiation of single or multiple elimination diets or reintroduction of previously eliminated food groups).

    6. May be on any background PPI and/or STC, during the course of the study, as long as background medications have been stable for at least 8 weeks prior to the screening/run-in period (Visit 1) and there is agreement not to change background medication or dosage unless medically indicated, during the screening/run-in and treatment period.

    7. Participants currently leukotriene inhibitors and/or steroid treatments for asthma or allergies that are inhaled or administered intranasally, must report a stable dose for at least 4 weeks prior to the screening/run-in period (Visit 1).

    8. If a medication for EoE (including PPI and/or STC) is discontinued prior to the screening/run-in, there should be a washout period of at least 8 weeks prior to Visit 1. Discontinuation of any marketed biologic (monoclonal or polyclonal antibody) should have a washout period of 4 months or 5 half-lives prior to Visit 1, whichever is longer.

    9. Participants must have previously documented standard of care treatment, which could include PPI and/or STC and/or diet.
    1. El participante debe tener entre 12 y 80 años en el momento de firmar/asentir el consentimiento informado.

    2. Peso ≥ 40 kg en la visita 1.

    3. Diagnóstico establecido de EoE con una EGD (esofagogastroduodenoscopia) y biopsia esofágica previas que confirmen un diagnóstico de EoE.

    4. Participantes que tienen EoE sintomática definida por un promedio de al menos 2 episodios de disfagia (cualquier nivel de gravedad de lentitud a la hora de tragar los alimentos o de que estos se queden atascados en la garganta) por semana en las 4 semanas anteriores a la visita 1.

    5. Deben mantener una dieta estable durante al menos 8 semanas antes de la visita 1 y durante el transcurso del estudio (la dieta estable se define como la ausencia de inicio de dietas de eliminación de uno o múltiples grupos de alimentos o la reintroducción de grupos de alimentos previamente eliminados).

    6. Puede estar en tratamiento de base con cualquier IBP (inhibidor de la bomba de protones) y/o CTD (corticoesteroide tópico deglutido) durante el transcurso del estudio, siempre que el tratamiento de base se haya mantenido estable durante al menos 8 semanas antes del período de selección/rodaje (visita 1) y haya un acuerdo de no cambiar la medicación de base ni la dosis, a menos que esté médicamente indicado, durante el período de selección/rodaje y tratamiento.

    7. Los participantes que actualmente reciban tratamiento con inhibidores de leucotrienos y/o esteroides para el asma o las alergias que se inhalan o administran por vía intranasal deben informar de estar recibiendo una dosis estable durante al menos 4 semanas antes del período de selección/rodaje (visita 1).

    8. Si se interrumpe el tratamiento con un medicamento para la EoE (incluidos IBP y/o CTD) antes de la selección/rodaje, debe haber un período de reposo farmacológico de al menos 8 semanas antes de la visita 1. La interrupción del tratamiento con cualquier producto biológico comercializado (anticuerpo monoclonal o policlonal) debe tener un período de reposo farmacológico de 4 meses o 5 semividas antes de la visita 1, lo que sea mayor.

    9. Los participantes deben documentar haberse sometido previamente al tratamiento de referencia, que podría incluir IBP y/o CTD y/o dieta.
    E.4Principal exclusion criteria
    1. Other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, celiac disease, eosinophilic enteritis, colitis, diverticulitis, irritable bowel syndrome, or other clinically significant gastrointestinal conditions as per Investigator discretion.
    2.Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening.
    3. Use of a feeding tube, or having a pattern of not eating solid food daily.
    4. Hypereosinophilic syndrome, defined by multiple organ involvement and persistent blood eosinophil count > 1500 eosinophils/μL
    5. EGPA vasculitis
    6. Esophageal dilation performed within 8 weeks prior to screening.
    1. Otros trastornos gastrointestinales, como infección activa por Helicobacter pylori, antecedentes de acalasia, varices esofágicas, enfermedad de Crohn, colitis ulcerosa, enfermedad inflamatoria intestinal, celiaquía, enteritis eosinofílica, colitis, diverticulitis, síndrome del intestino irritable u otras afecciones gastrointestinales clínicamente significativas a juicio del investigador.

    2.Estenosis esofágica que impide el paso fácil de un endoscopio estándar o cualquier estenosis esofágica crítica que requiera dilatación en la selección.

    3. Uso de una sonda de alimentación o tener un patrón de no comer alimentos sólidos a diario.

    4. Síndrome hipereosinofílico, definido por afectación de múltiples órganos y recuento persistente de eosinófilos en sangre >1500 eosinófilos/µl.

    5. Vasculitis de tipo EGPA.

    6. Dilatación esofágica realizada en las 8 semanas anteriores a la selección.
    E.5 End points
    E.5.1Primary end point(s)
    1. Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels at Week 24
    2. Change from baseline in DSQ score at Week 24
    1. Respuesta histológica de recuento máximo de eosinófilos esofágicos por HPF de ≤6 en todos los niveles esofágicos disponibles en la semana 24.
    2. Variación respecto al inicio en la puntuación DSQ en la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Week 24
    2. Week 24
    1. Semana 24
    2. Semana 24
    E.5.2Secondary end point(s)
    1. Change from baseline in EoE EREFS at Week 24 and Week 52

    2. Change from baseline in EoE-HSS grade score at Week 24 and Week 52

    3. Change from baseline in EoE-HSS stage score at Week 24 and Week 52

    4. Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels at Week 52

    5. Change from baseline in DSQ score at Week 52

    6. Response of achieving clinico-histological remission at Week 24 and Week 52

    7. Change from baseline in peak esophageal eosinophil count (EOS/HPF) at Week 24 and Week 52

    8. Changes from baseline in PEESS Module at Week 24 and Week 52 (adolescents only)
    1. Variación respecto al inicio en la escala EREFS de EoE en la semana 24 y la semana 52.

    2. Variación respecto al inicio en la puntuación del grado HSS de EoE en la semana 24 y la semana 52.

    3. Variación respecto al inicio en la puntuación del estadio HSS de EoE en la semana 24 y la semana 52.

    4. Respuesta histológica de recuento máximo de eosinófilos esofágicos por HPF de ≤6 en todos los niveles esofágicos disponibles en la semana 52.

    5. Variación respecto al inicio en la puntuación DSQ en la semana 52.

    6. Respuesta para lograr la remisión clínico-histológica en la semana 24 y la semana 52.

    7. Variación respecto al inicio en el recuento máximo de eosinófilos esofágicos (EOS/HPF) en la semana 24 y la semana 52.

    8. Variación respecto al inicio en el módulo PEESS en la semana 24 y la semana 52 (solo adolescentes).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Varies depending on the endpoint/objective
    Varía en función del criterio de valoración / objetivo
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    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 trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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
    Israel
    Japan
    New Zealand
    United States
    Austria
    Finland
    Sweden
    Netherlands
    Spain
    Czechia
    Germany
    Greece
    Italy
    Belgium
    Denmark
    Norway
    Slovakia
    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
    LSLV
    LSLV
    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 days9
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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 Yes
    F.1.1Number of subjects for this age range: 36
    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: 36
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 314
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 211
    F.4.2.2In the whole clinical trial 360
    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 treatment period, participants will be eligible to participate in an active treatment extension period (lasting for a minimum of 24 weeks), followed by a 12-week off-treatment safety follow-up period. Participants who will not participate in the extension period will participate in a 12-week off-treatment safety follow-up period following completion of the 52-week treatment period
    Tras completar el periodo de tratamiento, los pacientes podrán ser elegidos para participar en un periodo de extensión del tratamiento (con una duración mínima de 24 semanas), seguido de un período de seguimiento de la seguridad de 12 semanas sin tratamiento. Los participantes que no participen en el período de ampliación participarán en un período de seguimiento de la seguridad de 12 semanas sin tratamiento después de completar el período de tratamiento de 52 semanas.
    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 Decision2023-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-26
    P. End of Trial
    P.End of Trial StatusOngoing
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