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    The EU Clinical Trials Register currently displays   43722   clinical trials with a EudraCT protocol, of which   7255   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-001034-11
    Sponsor's Protocol Code Number:CLOU064A2303B
    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:2022-09-14
    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 number2022-001034-11
    A.3Full title of the trial
    A multicenter, double-blind, placebo-controlled, randomized withdrawal and open-label extension study followed by long-term open-label treatment cycles to assess the efficacy, safety and tolerability of remibrutinib (LOU064) in adult chronic spontaneous urticaria patients who completed the preceding remibrutinib Phase 3 studies
    Estudio de extensión multicéntrico, abierto y doble ciego, controlado con placebo con retirada
    aleatorizada, seguido de ciclos de tratamiento abierto de larga duración para evaluar la eficacia,
    seguridad y tolerabilidad de remibrutinib (LOU064) en pacientes adultos con urticaria crónica
    espontánea que hayan completado los estudios anteriores de fase III de remibrutinib.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An extension study of long-term efficacy, safety and tolerability of remibrutinib in chronic spontaneous urticaria patients who completed preceding studies with remibrutinib
    Estudio de extensión de eficacia, seguridad y tolerabilidad a largo plazo de remibrutinib en pacientes con urticaria crónica espontánea que hayan completado los estudios anteriores de remibrutinib.
    A.4.1Sponsor's protocol code numberCLOU064A2303B
    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 number+34930353036
    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.3.1Product nameRemibrutinib
    D.3.2Product code LOU064
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNRemibrutinib
    D.3.9.2Current sponsor codeLOU064
    D.3.9.4EV Substance CodeSUB204118
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Chronic Spontaneous Urticaria
    Urticaria crónica espontánea (UCE).
    E.1.1.1Medical condition in easily understood language
    Chronic Hives
    Habones crónicos
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10072757
    E.1.2Term Chronic spontaneous urticaria
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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
    Epoch 1: Randomized withdrawal period
    To assess the efficacy of remibrutinib in CSU participants with a UAS7<16 at Week 52 in the prior core study with respect to time to first of the three events: relapse or study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication up to Week 24 compared to placebo
    Etapa 1: periodo de retirada aleatorizada
    Evaluar la eficacia de remibrutinib, en los participantes con UCE y un UAS7 (Weekly Urticaria Activity Score) <16 en la semana 52 del estudio principal anterior teniendo en cuenta el tiempo hasta que se produzca uno de estos tres acontecimientos:recaída, discontinuación del tratamiento del estudio
    debido a la falta de eficacia o ingesta de medicación prohibida que cause gran confusión hasta la semana 24 en comparacion con placebo
    E.2.2Secondary objectives of the trial
    To assess the long-term safety and tolerability of remibrutinib
    Evaluar la seguridad y la tolerabilidad a largo plazo de remibrutinib
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The study includes additional optional biomarker research components. Samples will be stored and analyzed depending on results of other biomarker assessments in this study, the overall study outcome, and/or other studies. Serum samples will be collected for autoantibodies assessment and the assessment of additional exploratory biomarkers, e.g., soluble FcR1. These serum samples may be used to better understand disease heterogeneity and for the identification of efficacy and/or stratification markers. Additionally, the effect of remibrutinib exposure on antibody titers may be assessed. Detailed descriptions of the assays will be included in the bioanalytical data reports. Biomarkers may also include targeted single or multiplex biomarkers panels (autoantibody, protein, peptide or metabolite biomarkers) or hypothesis-free platforms (autoantibody, protein, peptide and metabolite biomarkers).
    El estudio incluye componentes de investigación de los biomarcadores opcionales adicionales. Las muestras se conservarán y se analizarán según los resultados de otras evaluaciones de biomarcadores realizadas en este estudio, el resultado global del estudio o de otros estudios. Se recogerán muestras de suero para la evaluación de los autoanticuerpos y de los biomarcadores exploratorios adicionales, p. ej., FcR1 soluble. Estas muestras de suero podrían utilizarse para comprender mejor la heterogeneidad de la enfermedad e identificar los marcadores de eficacia o de estratificación. Asimismo, se puede evaluar el efecto de la exposición a remibrutinib en los títulos de anticuerpos. Se incluirán descripciones detalladas de las pruebas en los informes de datos bioanalíticos. Los biomarcadores también podrían incluir análisis individuales o multiplexados dirigidos de biomarcadores (autoanticuerpos, proteínas, péptidos o metabolitos) o plataformas que no requieren establecer hipótesis (autoanticuerpos, proteínas, péptidos o metabolitos).
    E.3Principal inclusion criteria
    - Written informed consent must be obtained before any assessment is performed.
    - Male and female, adult participants >/=18 years of age.
    - Participants who successfully completed the preceding core studies CLOU064A2301, CLOU064A2302, CLOU064A1301, CLOU064A2304 or CLOU064A2305 according to the respective protocols.
    - Willing and able to adhere to the study protocol and visit schedule.
    - El consentimiento informado por escrito se debe obtener antes de realizar cualquier
    evaluación.
    - Participantes adultos de ambos sexos >/= 18 años de edad.
    - Participantes que hayan completado de manera satisfactoria los estudios principales
    anteriores CLOU064A2301, CLOU064A2302, CLOU064A1301, CLOU064A2304 o CLOU064A2305 según los protocolos correspondientes.
    - Estar dispuesto a cumplir el protocolo del estudio y el calendario de visitas y ser capaz de hacerlo.
    E.4Principal exclusion criteria
    - Other diseases with symptoms of urticaria or angioedema, including but not limited to urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary angioedema, or drug-induced urticaria.
    - Any other skin disease associated with chronic itching that might influence in the investigator’s opinion the study evaluations and results, e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis.
    - Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA (New York heart association) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to enrollment), neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
    - Significant bleeding risk or coagulation disorders.
    - History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant.
    - Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.
    - Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants (NOACs)).
    - History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at the last 2 available visits of the preceding core study.

    Other protocol-defined exclusion criteria may apply.
    - Otras enfermedades con síntomas de urticaria o angioedema, que incluyen entre otras vasculitis urticarial, urticaria pigmentosa, eritema multiforme, mastocitosis, angioedema hereditario o urticaria inducida por fármacos.
    - Cualquier otra enfermedad cutánea asociada a picor crónico que pueda influir según el criterio del investigador en las evaluaciones y los resultados del estudio; p. ej., dermatitis atópica, penfigoide bulloso, dermatitis herpetiforme, prurito senil o psoriasis.
    - Signos de enfermedad cardiovascular de interés clínico (como, entre otros, infarto de miocardio, enfermedad isquémica cardíaca inestable, insuficiencia ventricular izquierda de clase III/IV de la NYHA [New York Heart Association], arritmia e hipertensión no controlada en los 12 meses anteriores al reclutamiento), trastornos neurológicos, psiquiátricos, pulmonares, renales, hepáticos, endocrinos, metabólicos y hematológicos, enfermedad gastrointestinal o inmunodeficiencia que, a juicio del investigador, pondría en riesgo la seguridad del participante, interferiría en la interpretación de los resultados del estudio o impediría la participación o el cumplimiento del protocolo por parte del participante.
    - Riesgo significativo de sangrado o trastornos de coagulación.
    - Antecedentes de sangrado gastrointestinalde interés clínico, p. ej., aquel que esté asociado al uso de fármacos antiinflamatorios no esteroideos (AINE).
    - Requisito de medicación antiplaquetaria, excepto el ácido acetilsalicílico hasta 100 mg/d o clopidogrel hasta 75 mg/d. El uso de tratamiento antiplaquetario dual (p. ej., ácido acetilsalicílico + clopidogrel) está prohibido.
    - Necesidad de recibir medicación anticoagulante (por ejemplo, warfarina o nuevos anticoagulantes orales [NACO]).
    - Antecedentes de enfermedad hepática o tratamiento actual para ello, incluida entre otras, hepatitis aguda o crónica, cirrosis o insuficiencia hepática o niveles de aspartato aminotransferasa (AST)/alanina aminotransferasa (ALT) superiores a 1,5 x el límite superior de normalidad (LSN) o índice internacional normalizado (INR) superior a 1,5 en las 2 últimas visitas disponibles del estudio principal anterior.

    Pueden aplicarse otros criterios de exclusión definidos por el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first composite event (i.e., relapse (UAS7>/=16), study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication) during the randomized withdrawal period
    Tiempo hasta el primer acontecimiento compuesto (es
    decir, recaída [UAS7 >/=16], discontinuación del tratamiento del estudio debido a la falta de eficacia o ingesta de medicación prohibida que cause una gran confusión) durante el periodo de retirada aleatorizada
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    Occurrence of treatment-emergent (serious and non-serious) adverse events during the extension study
    La aparición de acontecimientos adversos con el tratamiento (graves y no graves) durante el estudio de
    extensión.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Study
    Final del 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 No
    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 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 Yes
    E.8.1.7.1Other trial design description
    Estudio de extensión abierto, controlado con placebo con retirada aleatorizada (único brazo)
    Randomized withdrawal period (placebo-controlled) and open-label extension (single arm)
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA84
    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
    China
    Colombia
    India
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Singapore
    South Africa
    Taiwan
    Thailand
    United States
    Viet Nam
    Austria
    France
    Poland
    Bulgaria
    Spain
    Switzerland
    Czechia
    Germany
    Italy
    Denmark
    Hungary
    Russian Federation
    Slovakia
    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
    LVLS
    Última visita del último paciente (LPLV)
    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 days9
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days22
    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: 919
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 102
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 169
    F.4.2.2In the whole clinical trial 1021
    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)
    Should the participant complete this extension study prior to the investigational treatment becoming available in the country of the participant and is in the opinion of the investigator still deriving clinical benefit from remibrutinib, every effort will be made to continue provision of study treatment.
    En caso de que el participante haya completado este estudio de extensión antes de que el tratamiento en investigación esté disponible en su país y que, en opinión del investigador, siga obteniendo un beneficio clínico de remibrutinib, se hará todo lo posible para continuar proporcionándole el tratamiento del estudio.
    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 Decision2022-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-02
    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
    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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