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    Summary
    EudraCT Number:2021-005078-25
    Sponsor's Protocol Code Number:CHUBX2019/59
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2022-06-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-005078-25
    A.3Full title of the trial
    Phase III randomized, multicenter open label study to evaluate the efficacy of immunomodulatory therapy in case of psychiatric disorders with proven dysimmunity.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of immunomodulatory therapy in case of psychiatric disorders with proven dysimmunity.
    A.3.2Name or abbreviated title of the trial where available
    TIM-DEPIST
    A.4.1Sponsor's protocol code numberCHUBX2019/59
    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 SponsorCHU de Bordeaux
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFrench Ministry of Health and Solidarity as part of the 2019 PHRC-N
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Bordeaux
    B.5.2Functional name of contact pointCAPELLI Aurore
    B.5.3 Address:
    B.5.3.1Street Address12 rue Dubernat
    B.5.3.2Town/ cityTalence
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number330557820877
    B.5.6E-mailaurore.capelli@chu-bordeaux.fr
    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 MabThera
    D.2.1.1.2Name of the Marketing Authorisation holder ROCHE REGISTRATION GMBH
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameRituximab
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfusion (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Mental and behavioral disorders (F00-F99)
    E.1.1.1Medical condition in easily understood language
    Mental disorders (F00-F99)
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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
    Primary objective:
    To evaluate the efficacy at 3 months of immunotherapy for patients with psychiatric symptoms and proven auto-immunity (added to ongoing psychotropic treatment).
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    - To assess the efficacy at 1, 6 and 12 months of immunotherapy added to ongoing psychotropic treatment,
    - To evaluate the prevalence of auto-immune psychosis in France,
    - To assess the safety of immunotherapy in case of psychiatric symptoms,
    - To evaluate the kinetic of auto-Ab at 3 months.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The inclusion criteria are common for the two steps
    - For Adult patient:
    • First acute or relapse of psychiatric disorder (most often psychotic diseases or bipolar disorders) defined by the BPRS-E scale.
    - For Children patient:
    • Child over 6 years old with a first acute or relapse of psychiatric disorder defined by the Kiddie sads-PL scale.
    - For all patients:
    • Informed consent of the patient or his legal representatives
    • Effective contraception for women of childbearing potential
    E.4Principal exclusion criteria
    For the first step of the study (diagnostic)
    • Developmental disorder related to a genetic disease.
    • Co-existing disorder of severe neurological disease.
    • Chronic psychiatric disorders receiving ongoing neuroleptic treatment with efficacy.
    • Absence of consent from the patient or their legal representatives for the first step of the study
    • Pregnant or breastfeeding women.

    For the second step of the study (Intervention):
    • Patient for whom a diagnosis of autoimmune disease would not be made or for whom participation in step 2 would not be validated by the multidisciplinary concertation (MDC)
    • Absence of consent from the patient or their legal representatives for the second step of the study
    • Hypersensitivity to the active substance (rituximab) or to murine proteins, or to any of the other excipients
    • Blood platelets < 75x109/L
    • Neutrophils < 1.5x109/L
    • Neoplastic pathology,
    • Hepatitis B or HIV infection,
    • Contraindication to immunosuppressant treatment (active severe infection, severely immunocompromised state).
    • Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
    • Pregnancy at the randomization visit.
    • Concurrent enrolment in another pharmacological trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the remission of psychiatric symptoms at 3 months, defined as:
    - For adult patients: 20% decrease from baseline of BPRS-E scale
    - For patients <18years or adults patients included at adolescent age at 2nd step inclusion visit: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months after treatement initiation
    E.5.2Secondary end point(s)
    Secondary endpoints linked with the secondary objectives are:
    - The remission of psychiatric symptoms in each group of participants to the Step 2 of the trial, at month 1, 6 and 12
    - For adults patients:
    • Evaluation of severity CGI-S, CGI-I
    • Cognitive scales (GAF, MOCA)
    • Neurologic scales (KREBS, BUSH)
    • Psychiatric scales (BPRS-E, MINI)
    • Scale for psychosis evaluation PANSS
    • Scales for bipolar symptoms (MADRS, YMRS)
    • CBCL (only if they are included at adolescent age on step 2 inclusion visit and reach legal age during the step 2 of the study)

    - For children patients:
    • Evaluation of severity CGI-S, CGI-I
    • CBCL

    - Persistence rate of autoimmunity in psychiatric disorder at baseline for all participants to the Step 1 of the trial.
    - Level of NMDAr-Ab at 3 months in each group of participants to the Step 2 of the trial.
    - Frequency of serious and non-serious adverse events in each arm.
    - Frequency of infections in each arm.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at month 1, 6 and 12 after treatment initiation
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    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 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 No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    ongoing psychotropic treatment
    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 concerned9
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years
    E.8.9.1In the Member State concerned months38
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 200
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 150
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 800
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    First acute or relapse of psychiatric disorder (most often psychotic diseases or bipolar disorders) defined by the BPRS-E scale.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1000
    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 Decision2022-08-16
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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