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    Summary
    EudraCT Number:2020-003760-11
    Sponsor's Protocol Code Number:1346-0011
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-04
    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 ConcernedNorway - NOMA
    A.2EudraCT number2020-003760-11
    A.3Full title of the trial
    A phase III randomized, double-blind, placebo-controlled parallel group trial to examine the efficacy and safety of Iclepertin (BI 425809) once daily over 26 week treatment period in patients with schizophrenia (CONNEX-1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial of Iclepertin (BI 425809) effect on cognition and functional capacity in schizophrenia.
    A.3.2Name or abbreviated title of the trial where available
    BI 425809 Pivotal efficacy study 1
    A.4.1Sponsor's protocol code number1346-0011
    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 Norway KS
    B.1.3.4CountryNorway
    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 Pharma GmbH
    B.4.2CountryGermany
    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 number00498002430127
    B.5.5Fax number00498008217119
    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.3.9.4EV 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 placeboTablet
    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
    E.1.1.1Medical condition in easily understood language
    schizophrenia
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    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 Iclepertin as compared with 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 Iclepertin (BI 425809) 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.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A separate ocular substudy in selected countries will be conducted.
    E.3Principal inclusion criteria
    1. Patients must be capable of providing signed and dated written informed consent by date of Visit 1 in accordance with ICH Harmonized Tripartite Guideline for Good Clinical Practice (ICH-GCP) and the local legislation prior to the 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 to stay focused, difficulties to remember 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.
    -- For patients on two antipsychotics, at least one antipsychotic must be within the approved label dose range. The second antipsychotic must not exceed the maximum daily dose per local label.
    -- Switch from 1-month to 3-monthinjectable formulation of same antipsychotic during the 12 weeks prior to randomization is allowed, but not with in last 35 days prior to randomization.
    -- 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 Table of relevant medications and their equivalencies will be provided as a part of ISF.
    -- For any other psychoactive medications, doses cannot exceed the maximum daily dose per local label.

    Women of childbearing potential (WOCBP)5 must be ready and able to use highly effective methods of birth control per Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3 (R2)) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in Section 4.2.2.3. Such methods should be used throughout the trial, and for a period of at least 35 days after last trial drug intake, and the patient must agree to periodic pregnancy testing during participation in the trial.

    - Have a study partner, defined as any person either private or professional who knows the patient well, has been capable of interactingwith the patient on regular basis, and preferably consistent throughout the study.-- The study partner must interact with the subject a minimum 1 hour per week and, preferably, at least 2 times a week. At least one interaction per week should be in person.-- The study partner must have educational achievement of minimum 8thgrade.-- Professional study partners (e.g. study nurse, social worker etc.) are allowed if not involved in administration of any of the protocol assessments.
    - Patients must, in the investigator's opinion, exhibit reliability and physiologic capability (e.g. sufficient hearing, vision etc.), to comply with all protocol procedures, and have attained an educational achievement of minimum 8th grade.- Patients and his/ her study partner must be fluent in the language of the batteries/questionnaires.
    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 (i.e. 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. For a list of drugs assessed in the urine drug screen
    8. Patients who were treated with any of the following within 6 months prior to randomization:
    -- Clozapine
    -- Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil)
    -- Ketamine or esketamine
    -- Electroconvulsive therapy (ECT) or Modified ECT

    Participation in any investigational psychoactive drug trial (both industry/ academic) in last 6 months, and 30 days or 5 half-lives for no-psychoactive drug trial, prior to randomization.
    - Patients who were previously treated with Iclepertin
    - Patients who are treated with any of the following within the last 35 days prior to randomization:
    -- Strong or moderate CYP3A4 inhibitors including grapefruit juice
    -- Strong or moderate CYP3A4 inducers including St. John's wort (Hypericum perforatum)
    -- Dietary supplements and herbal remedies that may impact cognition, in the investigator ́s judgement
    -- Antiepileptics (when used for the treatment of epilepsy)
    -- Tricyclic antidepressants
    -- Traditional Chinese medicine/ non-Western therapy
    -- Medical devices therapy (e.g. TMS, neurofeedback)

    - Patients who plan to change their current life-style habits including butnot limited to alcohol, nicotine or caffeine use, or diet, during the treatment period.
    - Patients who have participated in a clinical trial with repeated assessments (i.e. a single assessment is not exclusionary) with the MCCB and/ or any other schizophrenia cognitive battery within 12 weeksprior to screening
    - Any formal Cognitive Remediation Therapy (CRT) within 12 weeks priorto screening. Initiation of CRT is not allowed during the study.
    - Initiation or change in any type or frequency of psychotherapy (e.g. cognitive behavioral therapy, social skills training, vocational/occupational therapy) within 12 weeks prior to randomization. Patients with ongoing, stable psychotherapy for more than 12 weeks prior to randomization (and intend to maintain the same frequency during the study) may qualify as per clinical judgement of the investigator.
    - Any of the following, in the judgment of the investigator:
    -- Clinically significant finding of the physical examination, vital signs (including blood pressure (BP) and pulse rate (PR)), ECG or laboratory value (as measured by the central laboratory) that would jeopardize the patient ́s safety while participating in the trial or their capability to participate in the trial.
    -- Symptomatic/unstable/uncontrolled or clinically relevant concomitantdisease or any other clinical condition that would jeopardize the patient ́s safety while participating in the trial or capability to participate in the trial.
    -- Significant or unstable physical condition that may require change in medication or hospitalization that would impact cognitive function.
    -- Planned major surgery requiring withdrawal from study medication formore than 2 weeks during the study period.

    - Haemoglobin (Hb) below lower limit of normal at Visit 1 assessed by the central lab.
    - Patients with known active infection with SARS-CoV-2 within the last 35 days prior to randomization.

    Further criteria apply.
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) week 26
    E.5.2Secondary end point(s)
    1) Key secondary endpoint: Change from baseline in the SCoRS interviewer total score after 26 weeks of treatment
    2) Keay secondary endpoint: Change from baseline to Week 26 in the adjusted total time T-score in the VRFCAT
    3) Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London.
    4) Change from screening visit 1a to Week24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) week 26
    2) week 26
    3) week 26
    4) week 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 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 Yes
    E.6.13.1Other scope of the trial description
    Voluntary speech samples will be collected after separate optional speech sampling informed consent has been given in accordance with local ethical and regulatory requirements in participating countries.
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Colombia
    New Zealand
    Philippines
    Australia
    Brazil
    Canada
    China
    Japan
    Mexico
    Russian Federation
    Turkey
    United States
    Germany
    Greece
    Italy
    Norway
    Poland
    Sweden
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 194
    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)
    Roll-over to open label extension trial for all patients who complete 26 weeks of treatment will be offered. For all patients, post trial treatment will be 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 Decision2021-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-24
    P. End of Trial
    P.End of Trial StatusOngoing
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