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    Summary
    EudraCT Number:2020-003744-84
    Sponsor's Protocol Code Number:1346-0012
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-04-29
    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 ConcernedFrance - ANSM
    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)
    Étude de phase III, randomisée, en double aveugle, contrôlée versus placebo, en groupes parallèles, afin d’évaluer l’efficacité et la sécurité du BI 425809 à 10 mg administré une fois par jour pendant 26 semaines chez des patients atteints de schizophrénie (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.
    Étude clinique de l’effet du BI 425809 sur la cognition et la capacité fonctionnelle dans la schizophrénie.
    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
    B.1.3.4CountryFrance
    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
    B.4.2CountryFrance
    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 number498002430127
    B.5.5Fax number498008217119
    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
    schizophrénie
    E.1.1.1Medical condition in easily understood language
    schizophrenia
    schizophrénie
    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.
    L’objectif principal de cet essai pivot de phase III est d’évaluer l’efficacité du BI 425809 à une dose de 10 mg versus placebo pendant 26 semaines sur l’amélioration des troubles cognitifs en utilisant l’échelle MCCB chez les patients atteints de schizophrénie.
    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.
    L’objectif secondaire clé est d’évaluer l’efficacité du BI 425809 à une dose de 10 mg versus placebo pendant 26 semaines sur le fonctionnement de la vie quotidienne en utilisant l’échelle SCoRS (Schizophrenia Cognition rating Scale) et l’outil VRFCAT (virtual reality Functionnal Capacity Assesment Tool).

    Les objectifs secondaires sont d’évaluer l’efficacité sur l’amélioration du raisonnement, la résolution des problèmes ainsi que l’amélioration des troubles cognitifs liés à la schizophrénie.
    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. Consentement éclairé daté et signé en accord avec les ICH-GCP et la législation française avant l’admission dans l’étude.
    2. Hommes ou femmes, âgés de 18 à 50 ans (inclus) au moment du consentement.
    3. Schizophrénie diagnostiquée (selon le DSM-5) présentant les caractéristiques cliniques suivantes :
    -- Patient en ambulatoire, stable cliniquement et étant dans la phase résiduelle (non aiguë) de la maladie.
    -- Patient n’ayant pas eu d’hospitalisation ou d’augmentation du niveau de soins psychiatriques en raison de l’aggravation de la schizophrénie dans les 12 semaines précédant la randomisation.
    -- Score PANSS : sur les items P1, P3-P6 ≤ 5 et sur les items P2 et P7≤ 4 à la visite 1, et confirmé à la visite 2.
    4. Les patients doivent avoir une déficience fonctionnelle pour les activités de la vie quotidienne telles que des difficultés à suivre une conversation ou à s’exprimer, des difficultés à rester concentrés, des difficultés à se souvenir d’instructions ou ce qu’il faut dire ou comment se rendre à des endroits, selon le jugement de l’investigateur.
    5. Les patients doivent être sous traitement antipsychotique stable (minimum 1 et maximum 2 antipsychotiques / clozapine non autorisée) depuis au moins 12 semaines et à la dose actuelle depuis au moins 35 jours avant la randomisation.
    -- Les doses doivent suivre les doses recommandées du RCP en France.
    Remarque : Si la dose totale est stable, différentes formes de dosage du même traitement antipsychotique seront considérées comme un seul antipsychotique.
    6. Les patients traités avec d’autres traitements psychoactifs concomitants (à l’exception des anticholinergiques) doivent être maintenus avec le même traitement pendant au moins 12 semaines et avec la dose actuelle / schéma thérapeutique pendant au moins 35 jours avant la randomisation. Dose quotidienne maximale de benzodiazépine équivalente à 1 mg de lorazépam et dose hypnotique équivalente jusqu'à 0,25 mg de brotizolam au besoin. Un tableau des traitements pertinents et de leurs équivalences sera présenté dans le classeur investigateur.
    -- Pour tout autre médicament psychoactif, les doses devraient se situer dans les doses recommandées du RCP en France.

    D'autres critères s'appliquent.
    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. Patients ayant un diagnostic autre que la schizophrénie, y compris mais non limité au trouble bipolaire, schizo-affectif, dépressif majeur etc. selon le DSM-5. Le questionnaire M.I.N.I. pour les troubles psychotiques doit être utilisé comme référence.
    2. Déficience cognitive due à un trouble développemental, neurologique (ex. épilepsie, accident vasculaire cérébral) ou à d’autres troubles, y compris traumatisme crânien, ou patients atteints de démence.
    3. Troubles graves du mouvement :
    -- Conduisant à une déficience cognitive (ex. démence de Parkinson), ou
    -- Interférant avec les évaluations d’efficacité, ou
    -- Dus au traitement antipsychotique qui ne peut pas être contrôlé par un traitement anticholinergique à faible dose (équivalent à 1 mg de benzatropine maximum deux fois par jour). Une liste des traitements interdits sera fournie dans le classeur investigateur.
    4. Tout comportement suicidaire au cours de l’année précédant la visite de sélection et pendant la période de sélection.
    5. Idées suicidaires de type 5 selon l’échelle C-SSRS (c.-à-d. pensées suicidaires actives avec plan et intention de passer à l’acte) au cours des 3 derniers mois et ce jusqu’à la visite 2.
    -- Les patients ayant des idées suicidaires de type 4 selon l’échelle C-SSRS (c-à-d pensée active avec intention mais sans un plan de passage à l’acte spécifique) au cours des 3 derniers mois et ce jusqu’à la visite 2 peuvent être randomisés, dans le cas où une évaluation réalisée et documentée par un professionnel de la santé mentale mentionne qu’il n’y a pas de risque immédiat de suicide.
    6. Antécédents de trouble modéré ou grave liés à la consommation de substances (autre que la caféine et la nicotine), tels que définis dans le DSM-5 au cours des 12 mois précédant la signature du consentement.
    7. Dépistage urinaire positif aux drogues à la Visite 1 selon les résultats du laboratoire centralisé.
    8. Patients ayant été traités avec l’un des traitements suivants dans les 6 mois précédant la randomisation :
    -- Clozapine,
    -- Stimulants (p. ex. méthylphénidate, dextroamphétamine, modafinil),
    -- Kétamine,
    -- Thérapie électroconvulsive (ECT) et ECT modifiée.

    D'autres critères s'appliquent.
    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) Changement par rapport à la valeur initiale du score total composite T de l’échelle MCCB après 26 semaines de traitement.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) week 26
    1) semaine 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) Changement par rapport à la valeur initiale du score total SCoRS après 26 semaines de traitement.
    2) Changement par rapport à la valeur initiale du temps total mesuré dans le VRFCAT après 26 semaines de traitement.
    3) Changement par rapport à la valeur initiale du nombre de réponses correctes du score T sur l’échelle ToL (Tower of London) après 26 semaines de traitement.
    4) Changement par rapport à la visite de sélection 1a du score total de l’échelle PRECIS (Patient Reported Experience of Cognitive Impairent in Schizophrenia) après 24 semaines de traitement.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) week 26
    2) week 26
    3) week 26
    4) week 24
    1) semaine 26
    2) semaine 26
    3) semaine 26
    4) semaine 24
    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 concerned4
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days3
    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 state15
    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 seperate open label extension trial (1346-0014). Otherwise, patients are managed according to standard of care.
    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 Decision2021-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-11
    P. End of Trial
    P.End of Trial StatusOngoing
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