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    Summary
    EudraCT Number:2019-001734-34
    Sponsor's Protocol Code Number:CLNP023D12201
    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:2019-09-04
    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 number2019-001734-34
    A.3Full title of the trial
    A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy.
    Ensayo clínico de prueba de concepto, aleatorizado, con tratamiento abierto, dosis ciega en grupos paralelos y tres brazos para investigar la eficacia y seguridad de LNP023 comparado con rituximab en el tratamiento de sujetos con nefropatía membranosa idiopática.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.
    Eficacia y seguridad de LNP023 comparado con rituximab en sujetos con nefropatía membranosa idiopática.
    A.4.1Sponsor's protocol code numberCLNP023D12201
    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 number34900353036
    B.5.5Fax number34932479903
    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 LNP023
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot yet established
    D.3.9.2Current sponsor codeLNP023
    D.3.9.3Other descriptive name LNP023 HYDROCHLORIDE SALT
    D.3.9.4EV Substance CodeSUB180361
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 2
    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 LNP023
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot yet established
    D.3.9.2Current sponsor codeLNP023
    D.3.9.3Other descriptive name LNP023 HYDROCHLORIDE SALT
    D.3.9.4EV Substance CodeSUB180361
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 3
    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 LNP023
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot yet established
    D.3.9.2Current sponsor codeLNP023
    D.3.9.3Other descriptive name LNP023 HYDROCHLORIDE SALT
    D.3.9.4EV Substance CodeSUB180361
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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 nameRituximab
    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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Membranous nephropathy
    Nefropatía membranosa idiopática
    E.1.1.1Medical condition in easily understood language
    Kidney disease
    Enfermedad renal
    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 LLT
    E.1.2Classification code 10027170
    E.1.2Term Membranous nephropathy
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of high dose LNP023 compared with rituximab
    Evaluar la eficacia de una dosis alta de LNP023 comparado con rituximab.
    E.2.2Secondary objectives of the trial
    - To assess the safety and tolerability of low and high dose of LNP023
    - To assess the relationship between LNP023 systemic drug exposure and pharmacodynamics, mode-of-action markers and clinical efficacy
    - To assess the difference in response between low (regimen A) and high (regimen B) dose of LNP023
    - To assess the effect of LNP023 compared with rituximab on proteinuria remission and renal function
    - To assess the pharmacokinetics of LNP023
    -Evaluar la seguridad y tolerabilidad de una dosis baja y alta de LNP023.
    -Evaluar la relación entre la exposición sistémica al fármaco LNP023 y la farmacodinámica, marcadores del mecanismo de acción y eficacia clínica.
    -Evaluar la diferencia en la respuesta entre una dosis baja (pauta A) y alta (pauta B) de LNP023.
    -Evaluar el efecto de LNP023 comparado con rituximab en la remisión de proteinuria y la función renal.
    -Evaluar la farmacocinética de LNP023.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female or male adult (≥18 years) subjects at screening visit with a diagnosis of idiopathic (primary) MN confirmed by renal biopsy within 24 months prior to screening. A renal biopsy may be taken at any time during the run-in period to confirm the diagnosis of MN and facilitate subject eligibility, if the most recent biopsy was performed greater than 24 months prior to the screening visit.
    • Anti-PLA2R antibody titer of ≥ 100 RU/mL at screening visit (based on the EuroImmun ELISA test)
    • Urine protein ≥ 3.5 g/24h at run-in and baseline visits
    • ≤50% reduction in both anti-PLA2R level and 24h urine protein between first measurement at screening or run-in visit and baseline
    • Estimated GFR (using the CKD-EPI formula) ≥ 45 mL/min per 1.73 m2 at run-in visit
    • Receiving stable dose at the maximum recommended dose according to local guidelines or maximum tolerated dose of ACEi and/or ARB and/or statins and/or diuretics for at least 8 weeks prior to Day 1
    • Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae (in accordance with local guidelines) at least 28 days prior to Day 1 and no longer than 5 years prior to Day 1
    • Sujetos de ambos sexos (>/=18 años) en la visita de selección con diagnóstico de NM idiopática (primaria) confirmada mediante biopsia renal durante los 24 meses anteriores a la selección. Si la biopsia más reciente se ha realizado más de 24 meses antes de la visita de selección, se podrá realizar una biopsia renal en cualquier momento durante el periodo de preinclusión para confirmar el diagnóstico de NM y facilitar la elegibilidad del sujeto.
    • Título de anticuerpos anti-PLA2R >/=100 UR/ml en la visita de selección (basándose en la prueba ELISA de EuroImmun).
    • Proteína en orina >/=3,5 g/24 h en las visitas de preinclusióny basal.
    • Disminución </= 50 % tanto en el nivel anti-PLA2R como en la proteína en orina de 24 horas entre la primera medición en la visita de selección o de preinclusión y la basal.
    • TFG estimada (mediante la fórmula del CKD-EPI) >/= 45 ml/min/1,73 m2 en la visita de preinclusión.
    • Sujetos que estén recibiendo una dosis estable de la dosis máxima recomendada de acuerdo con las directrices locales o la dosis máxima tolerada de IECA y/o ARAII y/o estatinas y/o diuréticos durante al menos 8 semanas antes del día 1.
    • Vacunación contra Neisseria meningitidis, Streptococcus pneumoniae y Haemophilus influenzae (de acuerdo con las directrices locales) al menos 28 días antes del día 1 y no más de 5 años antes del día 1.
    E.4Principal exclusion criteria
    • Secondary causes of MN, e.g. systemic autoimmune diseases, solid or haematological malignancies, infections or chronic intake of drugs (e.g. gold salts, NSAIDs, penicillamines)
    • Diagnostic renal biopsy showing evidence of crescent formation in glomeruli, suggestive of an alternative or additional diagnosis to primary idiopathic MN
    • Previous treatment with B-cell depleting or B-cell modifying agents such as, but not limited to rituximab, belimumab, daratumomab or bortezomib
    • Previous treatment with immunosuppressive agents such as cyclophosphamide, chlorambucil, mycophenolate mofetil (or equivalent), cyclosporine, tacrolimus or azathioprine within 90 days prior to Day 1. Low dose systemic corticosteroid therapy is permitted, though the subject should have been on stable dose equivalent to ≤10 mg prednisolone for at least 90 days prior to Day 1
    • Previous treatment with gemfibrozil or strong CYP2C8 inhibitors such as clopidogrel within 7 days prior to Day 1
    • Presence or suspicion (based on judgment of the investigator) of active infection within 30 days prior to Day 1, or history of severe recurrent bacterial infections
    • Causas secundarias de NM, p. ej., enfermedades autoinmunes sistémicas, tumores sólidos o hematológicos malignos, infecciones o consumo crónico de fármacos (p. ej., sales de oro, AINE y penicilaminas).
    • Biopsia renal de diagnóstico que muestre evidencia de formación semilunar en glomérulos, indicativa de un diagnóstico alternativo o adicional a la NM idiopática primaria.
    • Tratamiento previo con fármacos depletivos de células B o modificadores de células B como rituximab, belimumab, daratumumab o bortezomib, entre otros.
    • Tratamiento previo con fármacos inmunosupresores como ciclofosfamida, clorambucilo, micofenolato de mofetilo (o equivalente), ciclosporina, tacrolimus o azatioprina durante los 90 días anteriores al día 1. Se permite administrar una terapia con corticosteroides sistémicos a dosis bajas,
    aunque el sujeto deberá haber recibido una dosis estable equivalente a ≤10 mg de prednisolona durante al menos los 90 días anteriores al día 1.
    • Tratamiento previo con gemfibrozilo o inhibidores potentes de CYP2C8 como clopidogrel durante los 7 días anteriores al día 1.
    • Presencia o sospecha (basándose en el criterio del investigador) de infección activa durante los 30 días anteriores al día 1, o antecedentes de infecciones
    bacterianas recurrentes graves.
    E.5 End points
    E.5.1Primary end point(s)
    Ratio between baseline UPCR and UPCR at 24 weeks of treatment (from 24h urine collection)
    Relación entre el CPCO basal y el CPCO a las 24 semanas de tratamiento (de la recogida de muestras de orina de 24 horas).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Day 113 and Day 169
    Basal, Día 113 y Dia 169
    E.5.2Secondary end point(s)
    • ECG parameters, vital signs, safety laboratory data, physical exam and collection of AEs
    • Plasma levels of Bb and sC5b-9
    • UPCR measured in first morning void
    • Ratio between baseline UPCR and UPCR at 24 weeks of treatment (from 24h urine collection)
    • Proportion of subjects with a complete remission, defined as proteinuria ≤0.3 g/day at 24 weeks of treatment, derived from 24h urine collection
    • Proportion of subjects with a partial remission, defined as reduction of proteinuria from baseline ≥50% plus final UP ≤ 3.5 g/24h but >0.3 g/24h at 24 weeks of treatment, derived from 24h urine collection.
    • Change in eGFR applying the Chronic Kidney Disease Epidemiology Collaboration (CKD- EPI) equation from baseline to 24 weeks of treatment
    • Plasma: non-compartmental parameters in plasma related to total parent drug, including, but not limited, to Tmax, Cmax, AUClast and AUCtau will be calculated for each dose level.
    • Urine: renal plasma clearance derived from 24h urine at week 16.
    • ECG, constantes vitales, datos analíticos de seguridad, exploración física y recogida de AA.
    • Niveles plasmáticos de Bb y sC5b-9.
    • CPCO medido en la primera orina de la mañana.
    • Relación entre el UPCR basal y el UPCR a las 24 semanas de tratamiento (de la recogida de muestras de orina de 24 horas).
    • Proporción de sujetos con remisión completa, definida como proteinuria </=0,3 g/día a las 24 semanas de tratamiento, derivada de la recogida de orina de 24 horas.
    • Proporción de sujetos con remisión parcial, definida como disminución ≥50 % de la proteína en orina respecto a la basal más nivel de proteína en orina final </=3,5 g/24 h, pero >0,3 g/24 h, derivado de la recogida de orina de 24 horas.
    • El cambio en la TFGe se calcula mediante la ecuación desarrollada por el grupo Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) desde la basal hasta las 24 semanas de tratamiento.
    • Plasma: Para cada nivel de dosis se calcularán los parámetros no
    compartimentales en plasma relacionados con el fármaco original total, que incluyen Cmax, Tmax, AUClast y AUCtau, entre otros.
    • Orina: aclaramiento plasmático y renal derivado de la orina de
    24 horas en la semana 16.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Baseline, Day 1, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 266, EOS. Collection of AEs is continuous.
    • Baseline, Day 15, Day 29, Day 57, Day 113, Day 169, Day 266, EOS
    • Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 169, Day 266, EOS
    • Baseline, Day 113 and Day 169
    • Baseline, Day 113 and Day 169
    • Baseline, Day 113 and Day 169
    • Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 266, EOS
    • Day 15, Day 29, Day 57, Day 113, Day 169
    • Day 113
    • Basal, Dia 1, Dia 15, Dia 29, Dia 57, Dia 85, Dia 113, Dia 141, Dia 169, Dia 266, Fin de studio. REcogida de RE es continua
    • Basal, Dia 15, Dia 29, Dia 57, Dia 113, Dia 169, Dia 266, Fin de studio
    • Basal, Dia 15, Dia 29, Dia 57, Dia 85, Dia 113, Dia 169, Dia 266, Fin de studio
    • Basal, Dia 113 y Dia 169
    • Basal, Dia 113 y Dia 169
    • Basal, Dia 113 y Dia 169
    • Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 266, EOS
    • Day 15, Day 29, Day 57, Day 113, Day 169
    • Day 113
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    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 EEA19
    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
    Czech Republic
    France
    Germany
    India
    Netherlands
    Russian Federation
    Singapore
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Último paciente última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 57
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 72
    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
    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 Decision2019-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
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