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    Summary
    EudraCT Number:2022-001627-32
    Sponsor's Protocol Code Number:CVAY736Q12301
    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:2022-11-01
    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 number2022-001627-32
    A.3Full title of the trial
    A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment (VAYHIT2)
    Estudio de fase III, aleatorizado y doble ciego de ianalumab (VAY736) frente a placebo en combinación con eltrombopag en pacientes con trombocitopenia inmune primaria (PTI) que hayan tenido una respuesta insuficiente o una recaída después del tratamiento de primera línea con esteroides (VAYHIT2).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 3, randomized, double-blind, study of ianalumab (VAY736) versus placebo in addition to eltrombopag in primary immune thrombocytopenia (ITP) patients who failed steroids
    Estudio de fase III, aleatorizado y doble ciego de ianalumab (VAY736) frente a placebo en combinación con eltrombopag en pacientes con trombocitopenia inmune primaria (PTI) en los que hayan fracasado los esteroides.
    A.3.2Name or abbreviated title of the trial where available
    VAYHIT2
    VAYHIT2
    A.4.1Sponsor's protocol code numberCVAY736Q12301
    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 pointTrial Monitoring Organization (TMO)
    B.5.3 Address:
    B.5.3.1Street AddressGran vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code0813
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493035 3036
    B.5.5Fax number+3493247 9903
    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.3.1Product nameIanalumab
    D.3.2Product code VAY736
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIanalumab
    D.3.9.2Current sponsor codeVAY736
    D.3.9.4EV Substance CodeSUB193896
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    immune thrombocytopenia (ITP)
    Trombocitopenia inmune primaria (PTI)
    E.1.1.1Medical condition in easily understood language
    immune thrombocytopenia (ITP)
    Trombocitopenia inmune primaria (PTI)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10083842
    E.1.2Term Immune thrombocytopenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that the addition of ianalumab (either dose) to standard of care, eltrombopag, prolongs Time to Treatment Failure (TTF) compared to eltrombopag alone in participants with primary ITP who have had an insufficient response to or relapsed after first-line treatment with corticosteroids
    Demostrar que la adición de ianalumab (en cualquier dosis) al tratamiento estándar, eltrombopag, prolonga el tiempo hasta el fracaso del tratamiento (TFT), en comparación con eltrombopag en monoterapia, en participantes con trombocitopenia inmune primaria (PTI) que hayan tenido una respuesta insuficiente o una recaída después del tratamiento de primera línea con corticosteroides.
    E.2.2Secondary objectives of the trial
    1. To assess quality, time to and duration of response in each treatment arm
    2. To assess the rate of participants who successfully taper and discontinue eltrombopag in each treatment arm
    3. To assess the incidence and severity of bleeding in each treatment arm
    4. To assess the need for rescue treatments in each treatment group
    5. To evaluate treatment effects on ITP related symptoms, functioning, and health-related quality of life (HFRQoL)
    6. To assess B-Cell levels and immunoglobulin (lg) levels
    7. To assess ianalumab pharmacokinetics (PK)
    8. To assess the immunogenicity of ianalumab
    1. Evaluar la calidad, el tiempo hasta la respuesta y la duración de la respuesta en cada grupo de tratamiento
    2. Evaluar la tasa de participantes que reducen gradualmente la dosis de manera satisfactoria y discontinúan eltrombopag en cada grupo de tratamiento
    3. Evaluar la incidencia y la gravedad de sangrado en cada grupo de tratamiento
    4.Evaluar la necesidad de utilizar tratamientos de rescate en cada grupo de tratamiento
    5. Evaluar los efectos del tratamiento en los síntomas, el funcionamiento y la calidad de vida relacionada con la salud (HRQoL) en relación con la PTI
    6. Evaluar los niveles de células B y los niveles de inmunoglobulina (Ig)
    7. Evaluar la farmacocinética (PK) de ianalumab
    8. Evaluar la inmunogenicidad de ianalumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged 18 years and older on the day of signing the informed consent.
    2. A signed informed consent must be obtained prior to participation in the study.
    3. A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy± IVIG.
    4. Platelet count <30 G/L and assessed need for treatment (per physician's discretion).
    Other protocol defined criteria may apply
    1. Pacientes de ambos sexos de 18 años de edad o más el día de la firma del consentimiento informado.
    2. Se deberá firmar el consentimiento informado antes de la participación en el estudio.
    3. Un diagnóstico de PTI primaria, con respuesta insuficiente o recaída tras tratamiento de primera línea con corticosteroides ± IgIV.
    4. Recuento de plaquetas <30 G/L y necesidad de tratamiento valorada (según el criterio del médico).

    Pueden ser aplicables otros criterios de inclusión definidos por el protocolo
    E.4Principal exclusion criteria
    1. ITP patients who received second-line ITP treatments (other than corticosteroid therapy± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (max one week) before screening are eligible.
    2. Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia
    3. Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters
    4. Patients with current or history of life-threatening bleeding
    5. Patient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAB)-positive
    6. Patients with known active or uncontrolled infection requiring systemic treatment during screening period
    7. Patients with hepatic impairment
    8. Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication
    9. Female patients who are pregnant or nursing
    Other protocol defined criteria may apply
    1. Pacientes con PTI que hayan recibido tratamientos de segunda línea para la PTI (que no sea tratamiento con corticosteroides +/- IgIV) incluyendo esplenectomía. Sin embargo, son elegibles los pacientes expuestos a los agonistas de los receptores de la trombopoyetina (AR-TPO) durante un tiempo limitado (máximo una semana) antes de la selección
    2. Pacientes con anormalidades de interés clínico en las pruebas analíticas y pacientes con síndrome de Evans o cualquier otra citopenia
    3. Pacientes con antecedentes de trastornos hematológicos clínicamente significativos o con determinados parámetros hematológicos alterados
    4. Pacientes con sangrado actual o antecedentes de sangrado potencialmente mortal
    5. Pacientes con virus de la inmunodeficiencia humana (VIH), virus de la hepatitis C (VHC), antígeno de superficie de la hepatitis B (HBsAg)/ anticuerpo del núcleo del virus de la hepatitis B (HBcAB) positivos
    6. Pacientes con infección activa o no controlada conocida que requiera tratamiento sistémico durante el periodo de selección
    7. Pacientes con deterioro hepático
    8. Pacientes con trastornos de coagulación concurrentes y/o que reciban medicamentos antiplaquetarios o anticoagulantes
    9. Pacientes que estén embarazadas o en periodo de lactancia

    Pueden ser aplicables otros criterios de exclusión definidos por el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Time from randomization date until the first of the following events indicative of treatment failure:
    -platelet count below 30 G/L
    -start of a new ITP treatment
    -need for a rescue treatment
    -ineligibility to taper or inability to discontinue eltrombopag
    -death
    El tiempo desde la aleatorización hasta el fracaso del tratamiento definido como el tiempo que transcurre desde la aleatorización hasta:
    - recuentos de plaquetas por debajo de 30 G/L
    - el inicio de un nuevo tratamiento para la PTI
    - la necesidad de tratamiento de rescate
    - la inelegibilidad para reducir gradualmente la dosis de eltrombopag o la incapacidad para discontinuar este fármaco
    - muerte
    E.5.1.1Timepoint(s) of evaluation of this end point
    Randomization to end of study (up to 39 months after randomization of last participant)
    Aleatorización hasta el final del estudio (hasta 39 meses después de la aleatorización del último participante)
    E.5.2Secondary end point(s)
    1. Percentage of participants with any platelet count of at least 100 G/L in the absence of rescue treatment or new ITP treatment
    2. Percentage of participants with any platelet count of at least 50 G/L in the absence of rescue treatment or new ITP treatment
    3. Percentage of participants with a best response rate by either response or complete response
    4. Time from randomization to date of first response and time from randomization to date of first complete response
    5. Time from achievement of response to treatment failure
    6. Time from achievement of complete response to loss of complete response
    7. Probability to be treatment failure-free (as defined for the primary efficacy endpoint) after the end of treatment period
    8. Percentage of participants reporting bleeding events according to WHO bleeding scale
    9. Number of participants who are in need of rescue treatment in each treatment arm
    10. Percentage of participants who are in need of rescue treatment
    11. The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Fatigue 13a includes 13 items that assess fatigue in adults.
    12. The ITP-PAQ is a 44 item scale for measuring HRQoL in adults with ITP across ten scales: Symptoms, BotherPhysical Health, Fatigue/Sleep, Activity, Fear, Psychological Health, Work, Social Activity, Women's Reproductive Health, overall Qol. Each item is rated on a Likert
    type scale. Each scale is scored from O to 100. Higher scores represent better HRQoL
    13. Change from baseline in the frequency (percentage within CD45) and absolute number of CD19+ B-cell counts
    14. Time to B-cell recovery defined as >/=80% of baseline or >/= 50 cells/µL
    15. Change from baseline in immunoglobulin levels
    16. AUClast: Area under the curve from time zero to the last measurable concentration sampling time (tlast) AUCtau: Area under the curve calculated to the end of a dosing interval
    (tau)
    17. Cmax: Maximum (peak) observed plasma, blood, serum or other body fluid drug concentration
    18. Tmax: Time to reach maximum (peak) observed plasma, blood, serum or other body fluid drug concentration
    19. Racc: Accumulation ratio calculated using AUC values obtained after the last and first dose
    20. Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assessing the immunogenicity of ianalumab
    1. Proporción de participantes con algún recuento de plaquetas de al menos 100 G/L sin tratamiento de rescate ni ningún nuevo tratamiento para la PTI
    2. Proporción de participantes con algún recuento de plaquetas de al menos 50 G/L sin tratamiento de rescate ni ningún nuevo tratamiento para la PTI
    3. La proporción de participantes con la mejor respuesta de bien respuesta o de respuesta completa
    4. El tiempo desde la aleatorización hasta la primera respuesta y el tiempo desde la aleatorización hasta la primera respuesta completa
    5. Duración de respuesta
    6. Duración de la respuesta completa
    7. Probabilidad de no presentar fracaso del tratamiento (tal y como se define en la variable de eficacia principal) al final del periodo de tratamiento previsto
    8. Proporción de participantes con acontecimientos de sangrado de acuerdo con la escala de sangrado de la Organización Mundial de la Salud (OMS)
    9. Número de participantes que reciben tratamiento de rescate en cada brazo de tratamiento
    10. Proporción de participantes que reciben tratamiento de rescate
    11. El cuestionario PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form v1.0 Fatigue 13a incluye 13 elementos que evalúan la fatiga en adultos.
    12. El cuestionario ITP-PAG es una escala de 44 elementos para medir la calidad de vida relacionada con la salud en pacientes adultos con PTI a través de 10 escalas: Síntomas, molestía de la salud física, fatiga/sueño, actividad, miedo, salud psicológica, trabajo, actividad social, salud reproductiva de la mujer, calidad de vida general. Cada elemento es valorado con una escala tipo Likert. Cada escala puntúa de 0 a 100. Las puntuaciones máximas representan mejor calidad de vida.
    13. Cambio respecto a la basal en la frecuencia (porcentaje en CD45) y número absoluto de recuentos de células B CD19+
    14. Tiempo hasta la primera recuperación de células B, definido como >/=80 % del valor basal o >/=50 células/μl.
    15.Cambio respecto a la basal en los niveles de la inmunoglobulinas
    16. Área bajo la curva desde el tiempo cero hasta la última concentración cuantificable (tlast): Área bajo la curva calculada hasta el final de un intervalo de dosificación.
    17. Cmax: Concentración máxima (pico) del fármaco observada en plasma, sangre, suero u otro fluido corporal.
    18. Tmax: Tiempo para alcanzar la concentración máxima (pico) del fármaco observada en plasma, sangre, suero u otro fluido corporal.
    19. Racc: Ratio de acumulación calculada usando los valores del área bajo la curva obtenidos después de la última y primera dosis.
    20. Los anticuerpos anti fármaco (AAF) serán evaluados en las muestras recogidas de todos los participantes para evaluar la inmunogenicidad de ianalumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3,5-6,8-10,13-15: Randomization to end of study (up to 39 months after randomization of last participant)
    4: Time from randomization up to the longest observed treatment period duration
    7: End of planned treatment period
    11,12: From screening (baseline) until end of study (up to 39 months after randomization of last participant)
    16-20: After the first and last dose of study medication
    1-3,5-6,8-10,13-15:Aleatorización hasta el final del ensayo (hasta 39 meses después de la aleatorización del último paciente)
    4: Tiempo desde la aleatorización hasta la duración del periodo de tratamiento más larga observada.
    7: Final del periodo de tratamiento planificado.
    11, 12: Desde selección (basal) hasta la finalización del estudio (hasta 39 meses después de la randomización del último participante).
    16-20: Después de la primera y última dosis de la medicación estudio.
    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
    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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    China
    India
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Philippines
    Singapore
    Taiwan
    Thailand
    United States
    Austria
    France
    Netherlands
    Romania
    Spain
    Czechia
    Germany
    Italy
    Belgium
    Hungary
    Norway
    Turkey
    United Kingdom
    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
    Última visita último paciente (LSLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days15
    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: 112
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 54
    F.4.2.2In the whole clinical trial 150
    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)
    None
    Ninguno
    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 Decision2023-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-21
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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