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    Summary
    EudraCT Number:2020-003744-84
    Sponsor's Protocol Code Number:1346-0012
    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:2021-06-09
    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 number2020-003744-84
    A.3Full title of the trial
    A phase III randomized, double-blind, placebo-controlled, parallel group trial to examine the efficacy and safety of BI 425809 once daily over 26 week treatment period in patients with schizophrenia (CONNEX-2)
    Estudio de fase III, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y la seguridad de BI 425809 una vez al día durante un periodo de tratamiento de 26 semanas en pacientes con esquizofrenia (CONNEX-2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial of BI 425809 effect on cognition and functional capacity in schizophrenia.
    Estudio clínico del efecto de BI 425809 sobre la función cognitiva y la capacidad funcional en la esquizofrenia.
    A.4.1Sponsor's protocol code number1346-0012
    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 SponsorBoehringer Ingelheim España, 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 supportBoehringer Ingelheim España, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH &Co KG
    B.5.2Functional name of contact pointCT Disclosure & Data Transparency
    B.5.3 Address:
    B.5.3.1Street AddressBirkendorfer Str. 65
    B.5.3.2Town/ cityBiberach
    B.5.3.3Post code88397
    B.5.3.4CountryGermany
    B.5.4Telephone number+34 (93) 404-5100
    B.5.5Fax number+34 (93) 404-5580
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 BI 425809
    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 INNNone yet
    D.3.9.2Current sponsor codeBI 425809
    D.3.9.3Other descriptive nameBI 425809
    D.3.9.4EV Substance CodeSUB130377
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    schizophrenia
    esquizofrenia
    E.1.1.1Medical condition in easily understood language
    schizophrenia
    esquizofrenia
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this phase III pivotal trial in CIAS is to assess the efficacy in
    improving cognitive impairment using MCCB in patients with schizophrenia treated for 26
    weeks with BI 425809 10mg as compared with placebo.
    El objetivo principal de este ensayo pivotal de fase III es evaluar la eficacia en la mejora del deterioro cognitivo empleando la MCCB en pacientes con esquizofrenia tratados con 10 mg de BI 425809 durante 26 semanas en comparación con placebo.
    E.2.2Secondary objectives of the trial
    The key secondary objective is to assess the efficacy in daily functioning of 26-week treatment with BI 425809 10mg as compared with placebo in terms of Schizophrenia Cognition Rating Scale (SCoRS) and Virtual Reality Functional Capacity Assessment Tool (VRFCAT).

    The secondary objectives are to assess the efficacy in improving reasoning and problem solving and patients’ experience of cognitive impairment associated with their disease.
    El objetivo secundario clave de este estudio es evaluar la eficacia en el funcionamiento diario mediante la Escala de evaluación cognitiva en la esquizofrenia (SCoRS) y la Herramienta de evaluación de la capacidad funcional de realidad virtual (VRFCAT) en pacientes con esquizofrenia tratados con 10 mg de BI 425809 durante 26 semanas en comparación con placebo.

    Los otros objetivos secundarios son evaluar la eficacia en la mejora del razonamiento y la resolución de problemas y la experiencia de los pacientes con deterioro cognitivo asociado a su enfermedad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated written informed consent in accordance with International Council on Harmonisation for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
    2. Male or female patients who are 18-50 years (inclusive) of age at time of consent.
    3. Diagnosis of schizophrenia utilizing DSM-5 with the following clinical features:
    -- Outpatient, clinically stable and in the residual (non-acute) phase of their illness.
    -- No hospitalization or increase in level of psychiatric care due to worsening of schizophrenia within 12 weeks prior to randomization.
    -- PANSS score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 at Visit 1, and confirmed at Visit 2.
    4. Patients should have functional impairment in day-to-day activities such as difficulties following conversation or expressing themselves, difficulties staying focused, difficulties remembering instructions, what to say or how to get to places, per investigator judgement.
    5. Patients maintained on current antipsychotic treatment (minimum 1 and maximum 2 antipsychotics, but clozapine is not allowed) for at least 12 weeks and on current dose for at least 35 days prior to randomization.
    -- Doses should be within the recommended dose range listed in the approved product labelling of the country where the study is being conducted. Note: If the total dose is stable, different dosage forms of the same antipsychotic treatment will be considered as one antipsychotic.
    6. Patients with any other concomitant psychoactive medications (except for anticholinergics) need to be maintained on same drug for at least 12 weeks and on current dose/ regimen for at least 35 days prior to randomization. Maximum daily benzodiazepine load of up to 1 mg lorazepam-equivalent and hypnotic load up to 0.25 mg brotizolam-equivalent as needed (pro re nata, prn). Table of relevant medications and their equivalencies will be provided as a part of ISF
    -- For any other psychoactive medications, doses should be within the recommended dose range listed in the approved product labelling of the country where the study is being conducted.

    Further criteria apply.
    1. Consentimiento informado firmado y fechado de acuerdo con la ICH-GCP y la legislación local previamente a la admisión al estudio.
    2. Pacientes de ambos sexos de 18-50 años (inclusive) en el momento del consentimiento.
    3. Diagnóstico de esquizofrenia utilizando el Manual diagnóstico y estadístico de los trastornos mentales, quinta edición (DSM-5) con las siguientes características clínicas:
    -- Paciente ambulatorio, clínicamente estable y en fase residual (no aguda) de su enfermedad.
    -- Sin hospitalización ni aumento del nivel de atención psiquiátrica debido al empeoramiento de la esquizofrenia en las 12 semanas anteriores a la aleatorización.
    -- Puntuación PANSS: ítems P1, P3-P6 ≤ y ítem P2 y P7 ≤ 4 en la visita 1, y confirmados en la visita 2.
    4. Los pacientes deben presentar deterioro funcional en las actividades cotidianas, como dificultades para seguir una conversación o para expresarse, dificultades para seguir una conversación o para expresarse, dificultades para mantenerse centrados, dificultades para recordar instrucciones, qué decir o cómo llegar a un lugar, según el criterio del investigador.
    5. Pacientes mantenidos con el tratamiento antipsicótico actual (al menos 1 y como mucho 2 antipsicóticos, pero no se permite la clozapina) durante al menos 12 semanas y con la dosis actual durante al menos los 35 días previos a la aleatorización.
    -- Las dosis deben estar en el rango recomendado recogido en la información del medicamento aprobada en el país donde se lleva a cabo el estudio.
    Nota: Si la dosis total es estable, diferentes formas de dosificación del mismo antipsicótico se consideraran como uno solo.
    6. Los pacientes que reciban cualquier otro medicamento psicoactivo concomitante (excepto anticolinérgicos) deben mantenerse con el mismo fármaco durante al menos 12 semanas y con la dosis/pauta actual durante al menos los 35 días previos a la aleatorización. La dosis máxima diaria de benzodiazepinas será de hasta 1 mg equivalente a lorazepam y la hipnótica de hasta 0,25 mg equivalente a brotizolam según sea necesario (pro re nata, prn). La tabla de los medicamentos pertinentes y sus equivalencias se proporcionará como parte del Archivo del Investigador.
    -- Para otra medicación psicoactiva, las dosis deben estar en el rango recomendado según la información del producto aprobada en el país donde se lleva a cabo el estudio.

    Se aplican criterios adicionales.
    E.4Principal exclusion criteria
    1. Participant with current DSM-5 diagnosis other than Schizophrenia, including but not limited to bipolar, schizoaffective, major depressive disorder etc. M.I.N.I. for Psychotic disorders should be used for guidance.
    2. Cognitive impairment due to developmental, neurological (e.g., epilepsy, stroke) or other disorders including head trauma, or patients with dementia.
    3. Severe movement disorders
    -- Leading to cognitive impairment (e.g. Parkinson dementia), or
    -- Interfering with the efficacy assessments, or
    -- Due to antipsychotic treatment that cannot be controlled with low dose anticholinergic treatment (equal to maximum 1 mg benztropine twice daily). Table of relevant medications and their equivalencies will be provided as a part of ISF
    4. Any suicidal behavior in the past 1-year prior to screening and during the screening period.
    5. Suicidal ideation of type 5 in the C-SSRS (ie. active suicidal thought with plan and intent) in the past 3 months prior to screening and up to and including Visit 2.
    -- Patients with Suicidal Ideation type 4 in the C-SSRS (i.e. active suicidal thought with intent but without specific plan), within 3 months prior to screening and up to and including visit 2, can be randomized in the study, if assessed and documented by a licensed mental health professional that there is no immediate risk of suicide.
    6. History of moderate or severe substance use disorder (other than caffeine and nicotine), as defined in DSM-5 within the last 12 months prior to informed consent.
    7. Positive urine drug screen at Visit 1 based on central lab test.
    8. Patients who were treated with any of the following within 6 months prior to randomization:
    -- Clozapine
    -- Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil)
    -- Ketamine
    -- Electroconvulsive therapy (ECT) or modified ECT

    Further criteria apply.
    1. Paciente con diagnóstico actual según el DSM-5 distinto de esquizofrenia, incluidos, pero no limitados a trastorno bipolar, esquizoafectivo, trastorno depresivo mayor, etc. Se debe utilizar la M.I.N.I como guía para trastornos psicóticos.
    2. Deterioro cognitivo debido a trastornos del desarrollo, neurológicos (p. ej., epilepsia, ictus) u otros trastornos, como traumatismo craneoencefálico, o pacientes con demencia.
    3. Trastornos graves del movimiento.
    -- Que degeneren en deterioro cognitivo (p. ej., demencia de Parkinson), o
    -- Que interfieran con la evaluación de la eficacia, o
    -- Que no puedan ser controlados debido al tratamiento antipsicótico con dosis bajas de anticolinérgicos (equivalentes a un máximo de 1 mg de benzotropina dos veces al día). Se proveerán en el Archivo del Investigador las tablas con la medicación relevante y sus equivalencias.
    4. Cualquier comportamiento suicida en el año previo a la selección y durante el período de selección.
    5. Ideación suicida de tipo 5 en la C-SSRS (p.ej., pensamiento activo suicida con plan e intención) en los 3 meses previos a la selección y hasta la visita 2 inclusive.
    -- Los pacientes con ideación suicida de tipo 4 en la C-SSRS (p.ej., pensamiento suicida activo con intención pero sin un plan específico), en los 3 meses anteriores a la selección y hasta la visita 2 inclusive, pueden ser aleatorizados en el estudio, si un profesional en salud mental autorizado les evalúa y considera que no existe riesgo inmediato de suicidio.
    6. Antecedentes de trastorno de consumo de sustancias de moderado a grave (excepto cafeína y nicotina), como se define en el DSM-5 en los últimos 12 meses previos al consentimiento informado.
    7. Positivos en test de orina múltiple de drogas en la visita 1 basado en el test del laboratorio central.
    8. Pacientes que hayan sido tratados con alguno de los fármacos que se listan a continuación 6 meses antes de la aleatorización.
    -- Clozapina
    -- Estimulantes (p. ej., metilfenidato, dextroanfetamina, modafinilo)
    -- Ketamina
    -- Terapia electroconvulsiva (TEC) o TEC modificada.

    Se aplicarán criterios adicionales.
    E.5 End points
    E.5.1Primary end point(s)
    1) Change from baseline in overall composite T-score of the MCCB after 26 weeks of treatment.
    1) Cambio con respecto al inicio en la puntuación T compuesta general de la Batería cognitiva de consenso (MCCB) después de 26 semanas de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) week 26
    1) semana 26
    E.5.2Secondary end point(s)
    1) Change from baseline in the SCoRS interviewer total score after 26 weeks of treatment
    2) Change from baseline to Week 26 in the adjusted total time in the VRFCAT
    3) Change from baseline to Week 26 in the T-score of the number of correct responses on ToL.
    4) Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score
    1) Cambio respecto al inicio en la puntuación total del entrevistador de la SCoRS después de 26 semanas de tratamiento
    2) Cambio desde el inicio hasta la semana 26 en el tiempo total ajustado en la VRFCAT
    3) Cambio desde el inicio hasta la semana 26 en la puntuación T del número de respuestas correctas en la Torre de Londres (ToL)
    4) Cambión en la puntuación total de la experiencia notificada por el paciente del deterioro cognitivo en la esquizofrenia (PRECIS) desde la visita de selección 1a hasta la semana 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) week 26
    2) week 26
    3) week 26
    4) week 24
    1) semana 26
    2) semana 26
    3) semana 26
    4) semana 26
    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 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) 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Brazil
    Chile
    Japan
    Korea, Republic of
    Serbia
    Ukraine
    United States
    Croatia
    France
    Hungary
    Netherlands
    Poland
    Romania
    Slovakia
    Spain
    Argentina
    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
    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 months3
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days3
    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: 586
    F.1.3Elderly (>=65 years) No
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 234
    F.4.2.2In the whole clinical trial 586
    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)
    There is a separate open label extension trial (1346-0014). Otherwise, patients are managed according to standard of care.
    Existe un ensayo de extensión abierto independiente (1346-0014). De lo contrario, los pacientes son atendidos de acuerdo al tratamiento de referencia.
    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 Decision2021-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-08
    P. End of Trial
    P.End of Trial StatusOngoing
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