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    Summary
    EudraCT Number:2020-003745-11
    Sponsor's Protocol Code Number:1346-0014
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-10-21
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2020-003745-11
    A.3Full title of the trial
    An open label, single arm, extension trial to examine long-term safety of Iclepertin once daily in patients with schizophrenia who have completed previous Iclepertin Phase III trials.(CONNEX-X)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test long-term safety of Iclepertin in people with schizophrenia who took part in a previous CONNEX study
    A.4.1Sponsor's protocol code number1346-0014
    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 RCV GmbH & Co KG
    B.1.3.4CountryAustria
    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 RCV GmbH & Co KG
    B.4.2CountryAustria
    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 AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+498002430127
    B.5.5Fax number+498008217119
    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
    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.1.2 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 objective of this trial is to collect additional safety data in patients with cognitive impairment due to schizophrenia, who participated in and completed the 26-week treatment period with BI 425809 or matching placebo of one of the phase III clinical trial program for BI 425809 (trial # 1346-0011, 1346-0012, 1346-0013).
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated written informed consent in accordance with ICH Harmonized Tripartite Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial (Visit 1).
    2. Clinically stable outpatients who have been diagnosed with schizophrenia (as per Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)).
    3. Patients, who completed 26 weeks of treatment in the parent trial, must enter the extension trial within:
    • Within 2 weeks the end of treatment visit in 1346-0011, 1346-0013 (i.e. Follow Up 1 timepoint including the applicable time windows).
    • At the end of safety follow up in 1346--0012.(within 7 days of visit Follow Up 6).
    4. Women of childbearning potential (WOCBP) 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. 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.
    5. Have a study partner, defined as any person capable of understanding trial related procedures, with a minimum of 8th grade level of education, who knows the patient well, has been capable of interacting with the patient on regular basis (at least once a week, either private or professional). Study partner does not need to attend visits with the patient but must be reachable by phone. Study partner should preferably be the same person throughout the study, if possible
    • Professional study partner (e.g. study nurse, social worker etc.) are allowed if not involved in administering any of the protocol assessments.
    E.4Principal exclusion criteria
    1. Participant who developed DSM5 diagnosis other than Schizophrenia or any condition that would prevent the patient from participating in the extension trial (e.g. stroke, head trauma, developed dementia, severe uncontrolled movement disorders or other significant condition since enrolment into the parent phase III trial (1346-0011, 1346-0012 or 1346-0013).
    2. Any suicidal behavior and/ or suicidal ideation of type 5 based on the C-SSRS in parent trial and up to and including Visit 1 of this study.
    o Patients with Suicidal Ideation type 4 in the C-SSRS (active suicidal thought with intent but without specific plan), in the past 3 months prior to and including Visit 1, can be entered in the study, if assessed and documented by a licensed mental health professional that there is no immediate risk of suicide.
    3. Patients diagnosed with moderate or severe substance use disorder (other than caffeine and nicotine), as defined in DSM-5 while the patient was in parent trial and prior to Visit 1 of this study.
    4. Positive urine drug screen ≥ 3 times during the parent trial based on central lab test.
    5. Patients who are currently or wish to participate in another investigational drug trial.
    6. Any clinically significant finding in the judgment of the investigator such as :
    o Clinically significant finding on he Physical examination and/or ECG from the last assessment done in the parent trial.
    o Vital signs (including blood pressure (BP) and pulse rate (PR)) that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.
    o Symptomatic/unstable/uncontrolled or clinically relevant concomitant disease or any other clinical condition that would jeopardize the patient´s safety while participating in the trial or capability to participate in the trial.
    o Significant or unstable physical condition that may require change in medication or hospitalization that would impact cognitive function.
    7. Any significant central lab findings based on the last available lab result received during the parent trial such as:
    o Severe renal impairment defined as an eGFR < 30mL/min/1.73m²,
    o Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 times upper limit or normal or
    o Hb drop below 100g/L (10g/dL) OR Hb decrease of 25% or more from baseline and is below lower limit of normal in parent trial (alert 3 from last measure Hb in parental trial)
    o Patients who meet any of the withdrawal criteria before planned end of treatment (26 weeks) in parent trial.
    8. Patients who have been diagnosed with hemoglobinopathies during the parent trial.
    9. Patients with known ongoing severe or serious infection with SARS-CoV-2.
    10. Known history of HIV and/or known on-going Hepatitis B or C infections. As well as any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
    11. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
    12. Patients with an allergy to Iclepertin and/or any of the excipients (including serious lactose intolerance). A list of Iclepertin and placebo ingredients are provided in the Investigator’s Brochure.
    13. Patients who are currently treated or expected to be treated with any of the following: strong or moderate CYP3A4 inhibitors, strong or moderate CYP3A4 inducers, CYP3A4 sensitive substrates,. including grapefruit juice ad St. John’s wort (Hypericum perforatum) and substrates with a narrow therapeutic range (e.g., fentanyl, cyclosporine).
    E.5 End points
    E.5.1Primary end point(s)
    1) occurrence of treatment emergent adverse events (TEAEs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) 54 weeks
    E.5.2Secondary end point(s)
    1) Change from baseline in CGI-S to end of treatment.
    2) Change from baseline in hemoglobin to end of treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 52 weeks
    2) 52 weeks
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA93
    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
    Chile
    Colombia
    Kazakhstan
    Ukraine
    Taiwan
    Brazil
    China
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    Serbia
    United Kingdom
    United States
    Belgium
    Croatia
    Czechia
    Denmark
    Finland
    France
    Germany
    Greece
    Hungary
    Italy
    Lithuania
    Netherlands
    Norway
    Poland
    Romania
    Slovakia
    Spain
    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 years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days2
    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: 1401
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 477
    F.4.2.2In the whole clinical trial 1401
    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 Decision2023-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-27
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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