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    Summary
    EudraCT Number:2022-001865-11
    Sponsor's Protocol Code Number:TV44749-CNS-30096
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-24
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2022-001865-11
    A.3Full title of the trial
    A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study with an Open-Label, Long-Term Safety Phase to Evaluate the Efficacy, Safety, and Tolerability of Olanzapine for Extended-Release Injectable Suspension (TV-44749) for Subcutaneous Use as Treatment of Adult Patients with Schizophrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Test if TV-44749 is Effective in Relieving Schizophrenia
    A.3.2Name or abbreviated title of the trial where available
    SOLARIS Study - Subcutaneous OLAnzapine Extended-Release Injection Study
    A.4.1Sponsor's protocol code numberTV44749-CNS-30096
    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 SponsorTeva Branded Pharmaceutical Products R&D, Inc.
    B.1.3.4CountryUnited States
    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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva UK Limited
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressRidings Point, Whistler Drive
    B.5.3.2Town/ cityCastleford
    B.5.3.3Post codeWF10 5HX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442075407117
    B.5.6E-mailMedInfo@tevaeu.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 nameOlanzapine
    D.3.2Product code TV44749
    D.3.4Pharmaceutical form Powder and solvent for prolonged-release suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOlanzapine
    D.3.9.1CAS number 132539-06-1
    D.3.9.2Current sponsor codeTV-44749
    D.3.9.4EV Substance CodeSUB09426MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number885
    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 Yes
    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 placeboSolution for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Schizophrenia is a serious mental disorder in which people interpret reality abnormally. It is a severely debilitating psychotic disorder characterized by positive symptoms (eg, delusions, hallucinations, and grossly disorganized behavior) and negative symptoms (eg, affective flattening, alogia, and avolition).
    E.1.1.1Medical condition in easily understood language
    Schizophrenia is a mental disorder that may result in some combination of hallucinations, delusions, and extremely disordered thinking and behavior that impairs daily functioning and can be disabling
    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
    The primary objective is to evaluate the efficacy of TV-44749 in adult patients with schizophrenia.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    - to further evaluate the efficacy of TV 44749 based on additional parameters in adult patients with schizophrenia.
    - to evaluate the safety and tolerability of TV-44749 in adult patients with schizophrenia.
    - to evaluate the efficacy of TV 44749 from baseline to endpoint in Period 1 in adult patients with schizophrenia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. The patient is a male or female of any ethnic origin, 18 to 64 years of age, inclusive, at the time of screening.
    b. The patient is capable of providing signed informed consent. Patients will be asked to consent to share their information with a vendor that will verify that they are not currently participating or have not recently participated in another clinical study, unless prohibited by local requirements. In addition, all patients will be asked to provide consent for mandatory audio recording of the PANSS assessments.
    c. The patient has a current confirmed diagnosis of schizophrenia according to the DSM-5, for >1 year. Diagnosis must be reconfirmed by the SCID-5-CT.
    d. The patient has a total PANSS score between 80 and 120, inclusive, at screening and baseline (prior to randomization) with a score ≥4 on at least 2 of the following 4 items of the PANSS positive subscale: hallucinatory behavior, delusions, conceptual disorganization, or suspiciousness/persecution.
    e. The patient has exacerbation of schizophrenia that started ≤8 weeks prior to screening and would benefit from psychiatric hospitalization or continued hospitalization for symptoms of schizophrenia.
    f. The patient has a CGI-S score of ≥4 (moderately ill) at screening and baseline (prior to randomization).
    g. Patients who have received an antipsychotic treatment (other than clozapine) in the past year must have been responsive based on the investigator’s judgment.

    See protocol for full list of inclusion criteria.
    E.4Principal exclusion criteria
    a. The patient has a current clinically significant DSM-5 diagnosis other than schizophrenia.
    b. The patient has a known history of: (a) borderline personality disorder, antisocial personality disorder, or bipolar disorder; (b) traumatic brain injury causing ongoing cognitive difficulties, Alzheimer’s disease, or another form of dementia, or any chronic organic disease of the central nervous system; and (c) intellectual disability of a severity that would impact ability to participate in the study.
    c. The patient has an improvement (reduction) in the total PANSS score of ≥20% between screening and day 1.
    d. The patient was hospitalized for >14 days in the current exacerbation episode prior to screening.
    e. The patient has a significant risk of violent behavior based on the patient’s medical history or investigator’s judgment.
    f. The patient has a significant risk of committing suicide based on the patient’s medical history or C-SSRS, and the investigator’s judgment.
    Patients with a C-SSRS positive response to suicidal ideation items 3, 4, or 5 and/or positive suicidal behavior response in the past 6 months are not eligible.

    See protocol for full list of exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline to week 8 in the Positive and Negative Syndrome Scale (PANSS) total score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to week 8
    E.5.2Secondary end point(s)
    •Change in Clinical Global Impression-Severity (CGI-S) scale score from baseline to week 8
    •Change in Personal and Social Performance Scale (PSP) score from baseline to week 8

    The safety and tolerability endpoints will include, where appropriate, the following: adverse events (including serious adverse events, extrapyramidal symptoms, injection pain and other injection site reactions [local tolerability]), vital signs (blood pressure, pulse and orthostatic changes, and temperature), body weight, laboratory tests, electrocardiogram (ECG), concomitant medication use, time to all-cause discontinuation, all-cause discontinuation rates and discontinuation rates due to adverse events (tolerability), and the following rating scales:
    •Abnormal Involuntary Movement Scale (AIMS)
    •Simpson-Angus Scale
    •Barnes Akathisia Rating Scale
    •Columbia Suicide Severity Rating Scale (C-SSRS)
    •Calgary Depression Scale for Schizophrenia (CDSS)

    •Change in total PANSS score from baseline to weeks 1, 2, and 4
    •Change in Clinical Global Impression-Improvement (CGI-I) scale score from baseline to weeks 4 and 8
    •Change in CGI-S scale score from baseline to weeks 1, 2, and 4
    •Change in Patient Global Impression-Improvement (PGI I) scale score from baseline to week 8
    •Change in PGI-I scale score from baseline to weeks 2 and 4
    •Change in Schizophrenia Quality of Life Scale (SQLS) score from baseline to weeks 4 and 8
    •Change in PSP score from baseline to week 4
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 4 and Week 8
    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 No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    China
    India
    Israel
    Mexico
    Serbia
    United States
    Bulgaria
    Romania
    Spain
    Türkiye
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 640
    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 No
    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 state78
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 640
    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)
    No further treatment is planned by the sponsor after the patient completes his or her participation in this study. Patients will be advised to return to their primary physician for treatment continuation consideration. During the FU period (4 to 8 weeks after the last dose of IMP), patients may be treated for schizophrenia per the investigator’s judgment.
    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 Decision2023-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-08
    P. End of Trial
    P.End of Trial StatusOngoing
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