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    The EU Clinical Trials Register currently displays   40665   clinical trials with a EudraCT protocol, of which   6637   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2016-003292-22
    Sponsor's Protocol Code Number:CVAY736A2201
    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:2017-03-10
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-003292-22
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome
    Estudio de fase 2, multicéntrico, aleatorizado, doble ciego, controlado con
    placebo, de búsqueda de dosis para evaluar la seguridad y eficacia de
    múltiples dosis de VAY736 administradas por vía subcutánea en pacientes
    con síndrome de Sjögren primario de moderado a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS)
    Estudio de seguridad y eficacia de VAY736 en pacientes con síndrome de
    Sjögren primario (pSS)
    A.4.1Sponsor's protocol code numberCVAY736A2201
    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.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.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.5.4Telephone number+ 34 90 0353036
    B.5.5Fax number+ 34 93 2479903
    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
    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 nameVAY736 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Primary Sjogren’s syndrome
    Síndrome de Sjögren primario
    E.1.1.1Medical condition in easily understood language
    Sjogren's syndrome
    Síndrome de Sjögren
    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 19.1
    E.1.2Level PT
    E.1.2Classification code 10040767
    E.1.2Term Sjogren's syndrome
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate a dose response of VAY736 defined as change in multi-dimensional disease activity as assessed by the physician from baseline at 24 weeks
    Demostrar la dosis-respuesta de VAY736 definida como el cambio en la actividad multidimensional de la enfermedad medida por el investigador desde la basal hasta la semana 24.
    E.2.2Secondary objectives of the trial
    - To assess a dose response of VAY736 in the change from baseline of patient-reported disease activity measures at 24 weeks
    - To assess a dose response of VAY736 in the change from baseline of the patient reported outcomes at 24 weeks
    - To evaluate the effects of VAY736 on salivary gland function at 24 weeks
    - To assess PK of VAY736

    Other protocol-defined secondary objectives may apply.
    - Evaluar la dosis-respuesta de VAY736 en el cambio en la evaluación de
    actividad de la enfermedad por parte de los pacientes desde la basal
    hasta la semana 24
    - Evaluar la dosis-respuesta de VAY736 en el cambio en los resultados
    comunicados por los pacientes desde la basal a la semana 24
    - Evaluar los efectos de VAY736 en la función de las glándulas salivales
    en la semana 24
    - Evaluar la PK de VAY736

    Pueden aplicar otros objetivos secundarios definidos en el protocolo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Fulfilled revised American European US Consensus Group
    criteria for pSS
    - Seropositive at screening for anti-Ro/SSA antibodies
    - Documented salivary/lacrimal gland biopsy result confirming pSS
    diagnosis prior to the baseline visit

    - Other protocol-defined inclusion/exclusion criteria may apply
    - Cumplir los criterios revisados del American European Consensus
    Group para la clasificación de SSp
    - Seropositivo en la selección para anticuerpos anti-Ro/SSA.
    - Resultado documentado de una biopsia de la glándula salival/lacrimal que confirme diagnóstico de SSp previo a la visita basal.
    - Pueden aplicar otros criterios de inclusión/ exclusión definidos en el
    E.4Principal exclusion criteria
    - Secondary Sjogren’s syndrome
    - Use of other investigational drugs
    - Active viral, bacterial or other infections
    - Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at

    - Other protocol-defined inclusion/exclusion criteria may apply
    - Síndrome de Sjögren secundario
    - Uso de otros fármacos en investigación
    - Infecciones activas víricas, bacterianas u otras
    - Hepatitis B positiva, hepatitis C, VIH o resultados de test de
    tuberculosis en la selección
    - Pueden aplicar otros criterios de inclusión/ exclusión definidos en el
    E.5 End points
    E.5.1Primary end point(s)
    Dose-response measured by change in multi-dimensional disease activity as assessed by the physician
    Evaluar la dosis-respuesta en el cambio en la actividad multidimensional de la enfermedad medida por el investigador.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over 24 weeks
    Durante 24 semanas
    E.5.2Secondary end point(s)
    - Dose-response measured by change in patient-reported disease activity measures
    - Change in quality of life measured by PROs
    - Change in salivary gland function measured by flow rate
    - Pharmacokinetics of VAY736 over time
    - Assessment of AEs, SAEs, Immunogenicity

    Other protocol defined endpoints may apply
    - Evaluar la dosis-respuesta en el cambio en la evaluación de actividad
    de la enfermedad por parte de los pacientes
    - Evaluar la calidad de vida medida mediante PROs
    - Cambio en la función de las glándulas salivales
    - Farmacocinética del VAY736 a lo largo del tiempo
    - Medida de AA, AAG, Inmunogenetica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over 24 weeks
    Durante 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 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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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
    Russian Federation
    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 ultimo paciente complete su Visita de fin del estudio y cualquier evaluación repetida asociada con esta visita haya sido documentada y seguida apropiadamente por el investigador.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 126
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 94
    F.4.2.2In the whole clinical trial 180
    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.
    Se pedirá que cada subjeto complete el estudio en su totalidad y posteriormente, no habrá disposnible para ellos ningún tratamiento del estudio.

    El investigator tendra que proporcionar tratamiento medico de seguimiento para todos los pacientes que prematuramente abandonen el estudio o tendra que referirles para un tratamiento médico adecuado.
    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 Decision2017-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-14
    P. End of Trial
    P.End of Trial StatusOngoing
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    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
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