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    Summary
    EudraCT Number:2017-001555-32
    Sponsor's Protocol Code Number:CVAY736B2201
    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:2017-10-11
    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 number2017-001555-32
    A.3Full title of the trial
    A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER).
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis, confirmatorio y de dos partes para evaluar la eficacia y seguridad de VAY736 en pacientes con hepatitis autoinmunitaria (HAI) con respuesta incompleta o
    intolerancia al tratamiento estándar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver
    Ensayo clínico para averiguar si VAY736 puede ayuda a las personas con hepatitis autoinmune, una enfermedad donde su sistema inmunológico ataca a su propio hígado
    A.3.2Name or abbreviated title of the trial where available
    AMBER
    A.4.1Sponsor's protocol code numberCVAY736B2201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03217422
    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 SponsorNovartis Farmacéutica S.A
    B.1.3.4CountrySpain
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointDepartamento Médico (ICRO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number++34900353036
    B.5.5Fax number++34932479903
    B.5.6E-maileecc.novartis@novartis.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.3.2Product code VAY736
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    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 INNNot established
    D.3.9.1CAS number Not establis
    D.3.9.2Current sponsor codeVAY736
    D.3.9.3Other descriptive nameanti-BAFFr antibody
    D.3.9.4EV Substance CodeSUB31641
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 No
    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
    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
    Autoimmune Hepatitis (AIH)
    Hepatitis Autoinmunitaria (HAI)
    E.1.1.1Medical condition in easily understood language
    Autoimmune hepatitis is a disease where your immune system attacks your own liver
    La hepatitis autoinmunitaria es una enfermedad donde su sistema inmune ataca su propio hígado
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10003827
    E.1.2Term Autoimmune hepatitis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of the study is 2-fold:
    Part 1 - To evaluate whether VAY736 is superior to placebo on alanine aminotransferase (ALT) at Week 24, in patients with AIH who are incomplete responders (i.e. did not achieve normalization of ALT) or intolerant to standard therapy.

    Part 2 - To confirm the efficacy (biochemical and histological remission) and safety of the dose determined from Part 1 in this population.
    El propósito del estudio es doble:
    Parte 1 - Evaluar si VAY736 es superior a placebo con respecto a la alanino aminotransferasa (ALT) en la semana 24, en pacientes con HAI que sean respondedores incompletos (es decir, que no hayan alcanzado la normalización de ALT) o intolerantes al tratamiento estándar.
    Parte 2 - Confirmar la eficacia (remisión bioquímica e histológica) y seguridad de la dosis determinada en la parte 1 en esta población
    E.2.2Secondary objectives of the trial
    Part 1 aims to evaluate the dose-response relationship of VAY736 with respect to normalization in ALT at Week 24.

    Other protocol-defined secondary objectives may apply
    Parte 1 - Evaluar la relación dosis-respuesta de VAY736 respecto a la normalización de ALT en la semana 24.

    Pueden aplicarse otros objetivos secundarios definidos por el protocolo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - AIH diagnosed per International Autoimmune Hepatitis Group
    - Liver biopsy with Ishak modified HAI indicating active AIH
    - Incomplete response to OR intolerance of standard therapy (per AASLD)

    Other protocol-defined inclusion criteria may apply
    -HAI diagnosticada de acuerdo con los criterios de diagnóstico del International Autoimmune Hepatitis Group (IAIHG)
    -Biopsia hepática con Ishak modificado que indica HAI active
    - Respuesta incompleta o intolerancia al tratamiento estándar (según las guías de la AASLD)

    Pueden aplicarse otros criterios de inclusión definidos por el protocolo
    E.4Principal exclusion criteria
    - Prior use of any B-cell depleting therapy
    - Required regular use of medications with known hepatotoxicity
    - Decompensated cirrhosis
    - Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC)
    - Drug related AIH at screening or a history of drug related AIH
    - History of drug abuse or unhealthy alcohol use
    - History of malignancy of any organ system
    - Pregnant or nursing (lactating) women
    - Other protocol-defined exclusion criteria may apply
    -El uso previo de algún tratamiento depletivo de células B previo
    -Necesidad de uso periódico de medicación con hepatotoxicidad conocida
    - Cirrosis descompensada
    - Diagnóstico de síndrome de superposición con la hepatitis autoinmunitaria (p. ej., HAI+CBP, HAI+CEP).
    - HAI relacionada con fármacos en la selección o antecedentes de HAI relacionada con fármacos.
    - Antecedentes de abuso de drogas o consumo nocivo de alcohol
    - Historial de malignidad de cualquier sistema de órganos
    - Mujeres embarazadas o en periodo de lactancia
    - Pueden aplicarse otros criterios de exclusión definidos por el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: ALT normalization
    Parte 1: normalización de ALT
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semanas
    E.5.2Secondary end point(s)
    Part 1: ALT normalization by dose
    Part1: normalización ALT por dosis
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semanas
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenicidad
    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) Yes
    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 trial4
    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 EEA33
    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
    Belgium
    Canada
    Czech Republic
    Denmark
    Germany
    Japan
    Netherlands
    Spain
    Sweden
    Switzerland
    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 study will complete when the last subject completes their Study Completion visit, and any repeat assessments associated with this visit have been documented and followed-up appropriately by the Investigator.
    El estudio se completará cuando el último sujeto complete su visita de finalización del estudio, y todas las evaluaciones repetidas asociadas a esta visita deben ser documentadas y seguidas apropiadamente por el investigador.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 80
    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)
    Each subject will be required to complete the study in its entirety and thereafter no further study treatment will be made available to them.
    The investigator must provide follow-up medical care for all patients who are prematurely withdrawn from the study, or must refer them for appropriate ongoing care.
    Cada sujeto será requerido para completar el estudio en su totalidad posteriormente no habrá ningún tratamiento adicional disponible para ellos.
    El investigador debe proporcionar atención médica de seguimiento para todos los pacientes que sean retirados prematuramente del estudio, o debe referirlos para un cuidado continuo apropiado.
    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 Decision2017-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-07
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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