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    Summary
    EudraCT Number:2018-004532-30
    Sponsor's Protocol Code Number:R092670PSY3016
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-18
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-004532-30
    A.3Full title of the trial
    Single-arm, Open-label Extension to a Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 24 month Open-Label, international study of paliperidone 6 month formulation in patients with who have completed study R092670PSY3015

    Schizophrenia is a mental illness with a number of symptoms, including disorganised thinking and speech, hearing or seeing things that are not there and delusions (fixed, false beliefs).
    A.4.1Sponsor's protocol code numberR092670PSY3016
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31071 524 2166
    B.5.5Fax number31071 524 2110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 name1092mg paliperidone palmitate extended release suspension for injection (eq. 700 mg paliperidone)
    D.3.2Product code R092670
    D.3.4Pharmaceutical form Prolonged-release suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPALIPERIDONE PALMITATE
    D.3.9.1CAS number 199739101
    D.3.9.2Current sponsor codeR092670
    D.3.9.3Other descriptive namePALIPERIDONE PALMITATE
    D.3.9.4EV Substance CodeSUB31687
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    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.IMP: 2
    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 name1560 mg paliperidone palmitate extended release suspension for injection (eq. 1000 mg paliperidone)
    D.3.2Product code R092670
    D.3.4Pharmaceutical form Prolonged-release suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPALIPERIDONE PALMITATE
    D.3.9.1CAS number 199739101
    D.3.9.2Current sponsor codeR092670
    D.3.9.3Other descriptive namePALIPERIDONE PALMITATE
    D.3.9.4EV Substance CodeSUB31687
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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, a mental illness with a number of symptoms, including disorganised thinking and speech, hearing or seeing things that are not there and delusions (fixed, false beliefs)
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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
    To assess the long-term safety and tolerability of PP6M (700 or 1000 mg eq.) and to provide access to PP6M in subjects with schizophrenia completing the R092670PSY3015 study without relapse.
    E.2.2Secondary objectives of the trial
    • To assess the long-term efficacy of PP6M based on:
    - Overall symptom improvement and global severity of the illness
    - Personal and social functioning
    - Remission rates

    • To continually assess the long-term effectiveness of PP6M on the prevention of relapse by evaluating the data from R092670PSY3015 and R092670PSY3016.

    • To evaluate the impact of PP6M on Medical Resource Utilization
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Completed the Double-blind Phase of Study R092670PSY3015 without relapse and continue to be willing to be treated with PP6M.
    Note: There may be a small number of subjects who complete Study R092670PSY3015 before the R092670PSY3016 protocol is approved and implemented in that local country. These subjects may be screened and can enter Study R092670PSY3016 later, provided that: Visit 1 (Day 1) of Study R092670PSY3016 (ie, first dose of PP6M) is scheduled to occur no later than 3 months after the End-of-Study visit of R092670PSY3015, that in the interim period the subject has been treated with PP1M (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.) (PP3M is preferred) and has not experienced a relapse (per criteria in Section 9.2.4, Relapse Criteria), and the subject meets other criteria for study entry.

    2. Must, in the opinion of the investigator, be able to continue treatment at the same dose level (moderate or higher dose) as used during the Double-blind Phase of Study R092670PSY3015 at the time of screening for this study.

    3. A woman of childbearing potential must have a negative urine pregnancy test on Day 1.

    4. Use contraception consistent with local regulations for subjects participating in clinical studies. Before receiving study intervention, a woman must be either:
    a. Not of childbearing potential, defined as being either postmenopausal or permanently sterile, as follows:
    ● Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level (>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.

    ● Permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy.

    b. Of childbearing potential, but meeting the contraception requirements as follows:
    ● Practicing a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly). Examples of highly effective contraceptives include the following:
    - User-independent methods: Implantable progestogen-only hormone contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system; vasectomized partner; sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention; the reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the subject).
    - User-dependent methods: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, and transdermal; progestogen-only hormone contraception associated with inhibition of ovulation: oral and injectable.
    .
    Typical use failure rates may differ from those when used consistently and correctly. Use should be consistent with local regulations regarding the use of contraceptive methods for subjects participating in clinical studies.

    ● Agree to remain on a highly effective method throughout the study and for at least 12 months after the last dose of study intervention. A woman using oral contraceptives should use an additional birth control method (see inclusion criterion text in the sub-bullet above).
    .
    Note: If the childbearing potential changes after start of the study or the risk of pregnancy changes (eg, a woman who is not heterosexually active becomes active), a woman must begin a highly effective method of contraception, as described throughout this inclusion criterion. If reproductive status is questionable, additional evaluation should be considered.
    A man must agree that during the study and for a minimum of 12 months after receiving the last dose of study intervention, his female partner(s) will use a highly effective method of contraception as described above, and:
    a) He must, if being sexually active with a woman of childbearing potential, use a barrier method of contraception (eg, condom with spermicidal foam/gel/film/cream/suppository).
    b) He must, if being sexually active with a woman who is pregnant, use a condom.
    c) He must agree not to donate sperm.

    6. Sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study; and must be able to provide his or her own consent (ie, consent cannot be provided by a legal representative of the subject).

    7. In the opinion of the investigator, the patient would be able to participate for the duration of this study.
    E.4Principal exclusion criteria
    1. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

    2. Completed R092670PSY3015 while presenting adverse events deemed clinically relevant by the investigator, and which may interfere with safety and well-being of the patient.

    3. If a man, has plans to father a child while enrolled in this study or within 12 months after the last dose of study intervention. Must not, if a woman, have plans to become pregnant while enrolled in this study or within 12 months after the last dose of study intervention.
    E.5 End points
    E.5.1Primary end point(s)
    • Safety: assessed through evaluation of adverse events, mental status
    examination, clinical laboratory values, vital signs, physical
    examinations, the Abnormal Involuntary Movement Scale (AIMS), and
    injection site evaluations. Mandatory assessments will occur at limited
    time points during the study with additional assessments to be added at
    the discretion of the investigator if considered necessary.
    • Proportion of subjects who receive 1, 2, 3, or 4 PP6M injections.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessed: Every 6 months and at end of trial
    E.5.2Secondary end point(s)
    ● Efficacy will be assessed based on the change from open-label extension baseline on:
    - The Clinical Global Impression-Severity (CGI-S) scale.
    - The Personal and Social Performance (PSP) scale.
    - The proportion of subjects in remission will be assessed based on the Positive and Negative Syndrome Scale (PANSS) assessment at open-label extension baseline, Month 12, Month 24, and the End-of-Study/Early Withdrawal visit.

    ● Effectiveness will be assessed based on relapse, where relapse in the open-label extension is defined as one or more of the following:
    - Psychiatric hospitalization for schizophrenia (involuntary or voluntary admission to a psychiatric hospital for decompensation of the subject’s schizophrenic symptoms);
    - Emergency Department/Room/Ward visit due to a worsening of the subject’s symptoms of schizophrenia, but a psychiatric hospitalization does not occur;
    - The subject inflicts deliberate self-injury or exhibits violent behavior resulting in suicide, clinically significant injury to him/her self or another person, or significant property damage;
    - The subject has suicidal or homicidal ideation and aggressive behavior that is clinically significant (in frequency and severity) in the investigator’s judgment.

    Based on the Healthcare Resource Utilization Questionnaire (HRUQ).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessed: Every 6 months and at end of trial
    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 Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA13
    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
    Hong Kong
    Italy
    Poland
    Ukraine
    E.8.7Trial has a data monitoring committee No
    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 days9
    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 days4
    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: 177
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 180
    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)
    After Open-label Treatment: Poststudy
    PP1M, PP3M, or another LAI antipsychotic at an interval appropriate to the open-label identity of the last study dose, as described in the approved prescribing information. The poststudy treatment after open-label treatment is at the discretion of the subject's physician;

    After Double-blind Treatment: Poststudy or Follow-up Phase
    Another antipsychotic treatment at the discretion of the subject's physician; and is not a study subjects medication.
    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 Decision2019-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
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