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    Summary
    EudraCT Number:2019-003211-57
    Sponsor's Protocol Code Number:CAIN457Q12301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-05-25
    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 number2019-003211-57
    A.3Full title of the trial
    A two-year, phase III randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the safety, efficacy, and tolerability of 300 mg s.c. secukinumab versus placebo, in combination with SoC therapy, in patients with active lupus nephritis
    Ensayo de fase III, aleatorizado, doble ciego, de grupos paralelos, controlado con placebo y de dos años de duración para evaluar la seguridad, eficacia y tolerabilidad de secukinumab 300 mg s.c. frente a placebo en combinación con el tratamiento estándar en pacientes con nefritis lúpica activa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate the safety, efficacy, and tolerability of secukinumab versus placebo, in combination with SoC therapy, in patients with active lupus nephritis
    Estudio de la seguridad, eficacia y tolerabilidad de secukinumab frente a placebo en combinación con el tratamiento estándar en pacientes con nefritis lúpica activa.
    A.3.2Name or abbreviated title of the trial where available
    SELUNE
    SELUNE
    A.4.1Sponsor's protocol code numberCAIN457Q12301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04181762
    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 code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34933064464
    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 Yes
    D.2.1.1.1Trade name Cosentyx
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameSecukinumab
    D.3.2Product code AIN457
    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 INNsecukinumab
    D.3.9.1CAS number 1229022-83-6
    D.3.9.2Current sponsor codeAIN457
    D.3.9.3Other descriptive nameSECUKINUMAB
    D.3.9.4EV Substance CodeSUB33242
    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 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
    Lupus Nephritis
    Nefritis lúpica
    E.1.1.1Medical condition in easily understood language
    Lupus Nephritis is an inflammation of kidneys caused by systemic lupus erythematosus, an autoimmune disease (body’s immune system targets its own body tissues) that can affect any part of the body.
    La nefritis lúpica es una inflamación de los riñones causada por el lupus eritematoso sistémico, una enfermedad autoinmune (el sistema inmunitario del cuerpo ataca sus propios tejidos corporales).
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10025140
    E.1.2Term Lupus nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary 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 that secukinumab 300 mg is superior to placebo in Complete Renal Response (CRR) rate at Week 52 in active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing Class V features) subjects on a background of SoC therapy.
    Demostrar que secukinumab 300 mg es superior a placebo en la tasa de respuesta renal completa (RRC) en la semana 52 en pacientes con nefritis lúpica activa (de clase III o IV de la International Society of Neurology / Renal Pathology Society (ISN/RPS), con o sin características coexistentes de la clase V) que reciban el tratamiento SoC de base.
    E.2.2Secondary objectives of the trial
    To demonstrate superiority of secukinumab compared to placebo in:
    Change from baseline in 24-hour Urine Protein-to Creatinine ratio (UPCR) at Week 52;
    Proportion of subjects achieving Partial Renal Response (PRR) at Week 52;
    Average daily dose of oral corticosteroids administered between Week 16 and Week 52;
    Proportion of subjects achieving PRR at Week 24;
    Time to achieve CRR;
    Time to achieve PRR;
    Time to achieve first morning void UPCR </=0.5 mg/mg;
    Change in FACIT-Fatigue© score at Week 52;
    ____
    Lack of space. Please refer to the Protocol to find all secondary objectives.
    Demostrar la superioridad de secukinumab frente a placebo en el cambio respecto a la basal en el cociente de proteína-creatinina en orina (CPCO) de 24 horas en la semana 52;
    Proporción de pacientes que alcancen una respuesta renal parcial (RRP) en la semana 52;
    Dosis diaria media de corticosteroides administrados por vía oral entre la semana 16 y la semana 52;
    Proporción de pacientes que alcancen una RRP en la semana 24;
    Tiempo transcurrido hasta alcanzar una respuesta renal completa (RRC);
    Tiempo transcurrido hasta alcanzar una RRP;
    Tiempo transcurrido hasta alcanzar un CPCO en la primera micción de la mañana </=0,5 mg/mg;
    Cambio de puntuación de la FACIT- Fatigue© en la semana 52;
    _____
    Falta de espacio. Por favor refiéranse al protocolo para encontrar todos los objetivos secundarios.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1) Biomarkers (2019-10-11, Version 00):
    Study includes additional, optional biomarker components. These optional assessments aim to identify potential markers of response and/or loss of response, and to characterize molecular mechanisms of treatment with secukinumab. Serum and urine biomarkers related to autoimmunity, renal inflammation and renal tissue injury will be measured.

    2) Pharmacogenetics: blood samples for DNA and RNA analyses (2019-10-11, Version 00):
    The genetic research is optional. The purpose of genetic research is to evaluate effect of genetic polymorphisms on treatment response and to better understand the safety and efficacy of secukinumab.
    1) Biomarcadores (2019-10-11, Versión 00):
    El estudio incluye biomarcadores opcionales adicionales. Estas evaluaciones opcionales tienen como objetivo identificar posibles marcadores de respuesta y / o pérdida de respuesta, y caracterizar los mecanismos moleculares de tratamiento con secukinumab. Se medirán los biomarcadores en suero y orina relacionados con la autoinmunidad, la inflamación renal y las lesiones del tejido renal.

    2) Farmacogenética: muestras de sangre para análisis de ADN y ARN (2019-10-11, Versión 00):
    La investigación genética es opcional. El propósito de la investigación genética es evaluar el efecto de los polimorfismos genéticos en la respuesta al tratamiento y comprender mejor la seguridad y la eficacia del secukinumab
    E.3Principal inclusion criteria
    1. Adult male and female subjects aged 18 - 75 years old at the time of Baseline.
    2. Confirmed diagnosis of:
    - SLE as defined by the American College of Rheumatology (ACR), OR
    - LN as the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies.
    3. Active lupus nephritis:
    - International Society of Neurology/Renal Pathology Society (ISN/RPS) Class III or IV LN [excluding III (C), IV-S (C) and IV-G (C)]; subjects are permitted to have co-existing Class V.
    - UPCR =>1 at Screening.
    - Estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73 m2.
    - Active urinary sediment.

    Other protocol-defined inclusion criteria may apply
    1. Pacientes adultos de ambos sexos con edades comprendidas entre los 18 y los 75 años en el momento de la basal.
    2. Diagnóstico confirmado de:
    · Lupus eritematoso sistémico (LES) según la definición del American College of Rheumatology (ACR).
    · Nefritis lúpica como criterio clínico único en presencia de anticuerpos antinucleares (ANA) o anticuerpos anti ADN bicatenario (anti-ADNdh).
    3. Nefritis lúpica activa:
    - NL de clase III o IV según la OMS o la ISN/RPS [excepto III (C), IV-S (C) e IV-G (C)]; está permitido que los pacientes presenten clase V coexistente.
    -CPCO =>1 en la selección.
    - Tasa de filtración glomerular estimada (TFGe) >30 ml/min/1,73 m2
    - Sedimento urinario activo

    Otros criterios de inclusión definidos en el protocolo pueden aplicarse.
    E.4Principal exclusion criteria
    1. Severe renal impairment and subjects requiring dialysis within the previous 12 months before Screening.
    2. Significant medical Problems like myocarditis, pericarditis, severe manifestations of neuropsychiatric SLE (NPSLE).
    3. Cyclophosphamide (CYC) use (i.v. or oral) or more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within the month prior to Baseline.
    4. Active ongoing inflammatory diseases.
    5. Previous exposure to secukinumab (AIN457) or any other biologic drug targeting IL-17 or the IL-17 receptor.
    6. Ongoing infections or malignant process.
    7. Pregnant or lactating women.

    Other protocol-defined exclusion criteria may apply
    1. Deterioro renal grave y pacientes que precisen diálisis durante los 12 meses anteriores a la selección.
    2. Presencia de problemas médicos significativos como miocarditis, pericarditis, o manifestaciones graves de LES neuropsiquiátrico (LESNP).
    3.Uso de CYC (i.v. u oral) o Administración de más de 3000 mg i.v. de metilprednisolona en pulsos (dosis acumulativa) durante las 12 semanas anteriores a la basal.
    4. Enfermedades inflamatorias activas en curso
    5. Exposición previa a secukinumab (AIN457) o a cualquier otro fármaco biológico dirigido contra IL-17A o el receptor de IL-17
    6.Infecciones recurrentes o procesos malignos
    7. Mujeres embarazadas o en periodo de lactancia

    Se pueden aplicar otros criterios de exclusión definidos por el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects achieving Complete Renal Response
    Proporción de pacientes que alcancen una Respuesta Renal Completa
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 Weeks
    52 semanas
    E.5.2Secondary end point(s)
    1. Change in 24-hour Urine Protein-to Creatinine Ratio (UPCR) at Week 52
    2. Proportion of patients achieving Partial Renal Response (PRR) at Week 52
    3. Average daily dose of oral corticosteroids administered between Week 16 and Week 52 compared to placebo
    4. Proportion of patients achieving PRR at Week 24
    5. Time to achieve CRR from Baseline to Week 52
    6. Time to achieve PRR from Baseline to Week 52
    7. Time to achieve first morning void UPCR ≤ 0.5 mg/mg from Baseline to Week 52
    8. Change in FACIT-Fatigue©, mean change of score compared to placebo from Baseline to Week 52
    9. Change in SF-36 PCS mean change compared to placebo from Baseline to Week 52
    10. Change in LupusQoL mean change of score compared to placebo from Baseline to Week 52
    11. Incidence of Treatment-emergent AEs (TEAEs) / SAEs from Baseline to Week 52; vital signs and body measurements, standard chemistry and hematology from Baseline to Week 52
    12. Estimate the proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52 in the secukinumab group (Week 52 to Week 104)
    13. Estimate the proportion of subjects with improved or mainatined response (PRR or CRR) in patients who had achieved at least PRR at week 52 in the secukinumab group
    1. Cambio en la proporción de proteína a creatinina en orina (CPCO) de 24 horas en la semana 52
    2. Proporción de pacientes que alcancen una respuesta renal parcial (RRP) en la semana 52
    3. Dosis diaria promedio de corticosteroides administrados por vía oral entre la semana 16 y la semana 52 en comparación con placebo
    4. Proporción de pacientes que logran RRP en la semana 24
    5. Tiempo para lograr CRR desde el inicio hasta la semana 52
    6. Tiempo para lograr RRP desde el inicio hasta la semana 52
    7. Tiempo hasta alcanzar un CPCO en la primera micción de la mañana =< 0.5 mg / mg desde el inicio hasta la semana 52
    8. Cambio en FACIT-Fatigue ©, cambio medio de la puntuación en comparación con el placebo desde el inicio hasta la semana 52
    9. Cambio mediante la puntuación SF-36 en comparación con el placebo desde el inicio hasta la semana 52
    10. cambio de puntuación del LupusQoL (salud física) en comparación con el placebo desde el inicio hasta la semana 52
    11. Incidencia de los AA emergentes (TEAE) / SAEs del tratamiento desde el inicio hasta la semana 52; signos vitales y medidas corporales, química estándar y hematología desde la basal hasta la semana 52
    12. Proporción de sujetos estimada con RRP en la semana 104 dentro de los pacientes que habían logrado RRP en la semana 52 en el grupo de secukinumab (semana 52 a la semana 104)
    13. Proporción de sujetos estimada con respuesta mejorada o mantenida (RRP o CRR) en pacientes que habían logrado al menos RRP en la semana 52 en el grupo de secukinumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 52
    2. Week 52
    3. Week 16 to Week 52
    4. Week 24
    5. Baseline to Week 52
    6. Baseline to Week 52
    7. Baseline to Week 52
    8. Baseline to Week 52
    9. Baseline to Week 52
    10. Baseline to Week 52
    11. Baseline to Week 52
    12. Week 52 to Week 104
    13. Week 52 to Week 104
    1. Semana 52
    2. Semana 52
    3. Semana 16 a la semana 52
    4. Semana 24
    5. Basal hasta la semana 52
    6. Basal hasta la semana 52
    7. Basal hasta la semana 52
    8. Basal hasta la semana 52
    9. Basal hasta la semana 52
    10. Basal hasta la semana 52
    11. Basal hasta la semana 52
    12. Semana 52 a Semana 104
    13. Semana 52 a Semana 104
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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
    Argentina
    Australia
    Brazil
    Canada
    Chile
    China
    Colombia
    Croatia
    Czech Republic
    Denmark
    Germany
    Greece
    Guatemala
    India
    Italy
    Japan
    Korea, Republic of
    Latvia
    Mauritius
    Mexico
    Norway
    Peru
    Philippines
    Portugal
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Thailand
    Turkey
    United Kingdom
    United States
    Vietnam
    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
    LVLS
    Última visita último paciente
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    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: 414
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 129
    F.4.2.2In the whole clinical trial 460
    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)
    The Investigator must provide follow-up medical care for all subjects, including subjects who are prematurely withdrawn from the study, or must refer them for appropriate ongoing care. This care may include initiating another treatment outside of the study, as deemed appropriate by the investigator.
    El investigador debe proporcionar atención médica de seguimiento para todos los pacientes, incluidos los pacientes que abandonen prematuramente del estudio, o bien deberá remitirlos a seguir recibiendo tratamiento continúo adecuado. Este cuidado puede incluir iniciar otro tratamiento fuera del estudio, según lo considere apropiado el investigador
    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 Decision2020-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-09-13
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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