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    Summary
    EudraCT Number:2021-001172-41
    Sponsor's Protocol Code Number:ITI-007-503
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-01-25
    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 number2021-001172-41
    A.3Full title of the trial
    An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder
    A.4.1Sponsor's protocol code numberITI-007-503
    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 SponsorIntra-Cellular Therapies, 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 supportIntra-Cellular Therapies, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIntra-Cellular Therapies, Inc.
    B.5.2Functional name of contact pointITI Clinical Trials
    B.5.3 Address:
    B.5.3.1Street Address430 East 29th Street, Suite 900
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10016
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1646-440-9333
    B.5.6E-mailITCIClinicalTrials@itci-inc.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 Yes
    D.2.1.1.1Trade name CAPLYTA
    D.2.1.1.2Name of the Marketing Authorisation holderIntra-Cellular Therapies, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLumateperone
    D.3.2Product code ITI-007
    D.3.4Pharmaceutical form Capsule
    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 INN lumateperone tosylate (salt); lumateperone (free base)
    D.3.9.1CAS number 1187020-80-9
    D.3.9.3Other descriptive nameITI-007 tosylate, ITI-007, FP-212, IC200056 tosylate salt, ITI-11-tosylate
    D.3.9.4EV Substance CodeSUB191580
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number42
    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
    Major Depressive Disorder
    E.1.1.1Medical condition in easily understood language
    Major Depressive Disorder
    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 LLT
    E.1.2Classification code 10025458
    E.1.2Term Major depressive disorder, recurrent episode, moderate degree
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10081270
    E.1.2Term Major depressive disorder
    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 evaluate the safety and tolerability of lumateperone 42 mg administered orally once daily for approximately 26 weeks as adjunctive treatment to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).
    E.2.2Secondary objectives of the trial
    To evaluate whether lumateperone 42 mg administered orally once daily for approximately 26 weeks as adjunctive treatment to ADT improves or maintains improvement of depressive symptoms in patients with MDD as measured by change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score and in the Clinical Global Impression Scale- Severity (CGI-S) score.

    Safety Objectives
    The purpose of the current study is to evaluate the safety and tolerability of lumateperone 42 mg as adjunctive treatment to antidepressant therapy (ADT) in patients with MDD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient entering the Open-label Safety Study must meet all of the following criteria:

    1. In the opinion of the Investigator, the patient must have safely completed the lead-in study.
    2. The patient must understand the written informed consent for the Open-label Safety Study, provide signed and witnessed written informed consent.
    3. The patient is taking his/her ADT as prescribed from the lead-in study.
    4. The patient must agree to continue using highly effective methods of birth control as specified in the lead-in study through the Safety-Follow-up Period of the Open-label Safety Study, or female patients or female partners of male patients must be of non-childbearing potential.
    E.4Principal exclusion criteria
    Because all patients enrolled in the lead-in study were required to satisfy exclusion criteria for participation in the lead-in study, the Investigator should assess if there has been any change in patient health status. Any newly-emergent medical condition reported during the lead-in study must be evaluated by the Investigator and should be discussed with the Sponsor or designee before enrolling the patient in the study.

    Patients enrolling directly from the lead-in study to the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1) will be excluded if they meet the following criteria:
    1. In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study.
    2. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or:
    a. At Visit 1/Day 1, the patient scores “yes” on Suicidal Ideation Items 4 or 5 of the C-SSRS “Since Last Visit” version;
    b. At Visit 1/Day 1, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts).
    3. Based on the Investigator’s clinical judgement, any abnormal clinical laboratory test or ECG results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study.
    4. The patient is breast-feeding or pregnant; female patients of childbearing potential must have a negative urine pregnancy test at Visit 1/Day 1.
    5. Has a positive urine drug test at Visit 1/Day 1. Positive tests attributable to prescription treatments (eg, opioids, benzodiazepines) may not be exclusionary if the use is not chronic and is able to be safely discontinued based on Investigator judgment and with the concurrence of the Sponsor or designee.
    6. The patient has any other condition that may be detrimental to the patient if she/he participates in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in MADRS total score and CGI-S score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline (Visit 2) to Day 43 (Visit 8)
    E.5.2Secondary end point(s)
    Analyses of efficacy endpoints will be performed based on the patients in the Safety Population who have an available baseline efficacy value and at least one postbaseline efficacy assessment during the Open-label Treatment Period. Analyses will primarily consist of change from baseline descriptive summaries of MADRS total score and CGI-S scores.

    All safety parameters will be summarized descriptively. Safety analyses will be based on the Safety Population defined as all patients who received at least one dose of open-label lumateperone 42 mg.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Additional efficacy parameters: every visit
    Safety: every visit
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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
    Ukraine
    Russian Federation
    United States
    Bulgaria
    Czechia
    Germany
    Hungary
    Poland
    Slovakia
    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
    Last patient last visit
    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 months11
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    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: 755
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state171
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 533
    F.4.2.2In the whole clinical trial 760
    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)
    return to the 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 Decision2022-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-10-23
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