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    Summary
    EudraCT Number:2021-005992-38
    Sponsor's Protocol Code Number:CMIJ821B12201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-08-29
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-005992-38
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, tolerability, and pharmacokinetics of single subcutaneous MIJ821 injection in addition to standard of care in participants with treatment-resistant depression
    Ensayo aleatorizado, doble ciego, controlado con placebo y de grupos paralelos en el que se evalúan la eficacia, la seguridad, la tolerabilidad y la farmacocinética de una única inyección de MIJ821 por vía subcutánea en combinación con el tratamiento estándar en participantes con depresión resistente al tratamiento.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy, safety, tolerability and pharmacokinetics of MIJ821 in participants with treatment- resistant depression (TRD)
    Estudio de eficacia, seguridad, tolerabilidad y farmacocinética de MIJ821 en participantes con depresión resistente al tratamiento (DRT).
    A.4.1Sponsor's protocol code numberCMIJ821B12201
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34 90 0353036
    B.5.5Fax number34 93 2479903
    B.5.6E-maileecc.novartis@novartis.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 nameMIJ821
    D.3.2Product code MIJ821
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    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 INNMIJ821
    D.3.9.2Current sponsor codeMIJ821
    D.3.9.3Other descriptive nameMIJ821
    D.3.9.4EV Substance CodeSUB195330
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    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
    Treatment Resistant Depression
    Depresión resistente al tratamiento.
    E.1.1.1Medical condition in easily understood language
    Depression
    Depresión
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057840
    E.1.2Term Major depression
    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 efficacy of MIJ821 (versus placebo) in treatment resistant depression after single s.c. injection
    Evaluar la eficacia de MIJ821 (frente a placebo) en la depresión resistente al tratamiento tras una única inyección s.c.
    E.2.2Secondary objectives of the trial
    - To assess safety and tolerability of MIJ821 after single s.c. injection
    - To assess MIJ821 PK in plasma after single s.c. injection
    - To assess the duration of antidepressant effect of MIJ821
    - To characterize the dose-response and exposure-response relationship of MIJ821
    - Evaluar la seguridad y la tolerabilidad de MIJ821 tras una única inyección s.c.
    - Evaluar la farmacocinética (PK) de MIJ821 en plasma tras una única inyección s.c.
    - Evaluar la duración del efecto antidepresivo de MIJ821.
    - Determinar las relaciones dosis-respuesta y exposición-respuesta de MIJ821.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed informed consent must be obtained prior to participation in the study.
    - Male and female participants, 18 to 65 years of age (inclusive) at screening.
    - Participant has a diagnosis of recurrent MDD and a current major depressive episode of at least 8 weeks in duration as defined by DSM-5 criteria and confirmed by both the MINI and an adequate clinical psychiatric evaluation at screening.
    - MADRS >/= 24 at screening and before randomization on Day 1.
    - Failure to respond to 2 or more antidepressant treatments but no more then 5, where the two failed treatments are two different antidepressants and at least one of which was used in the current depressive episode, with adequate dose and duration (>/= 6 weeks duration, doses defined per agent), as identified by the MGH-Antidepressant Treatment Response Questionnaire, based on the patient's report and prior psychiatric history, assessed by the investigator, and further documented by medical records. Patients with historical treatment failure to esketamine, ketamine or arketamine are excluded.
    - Participant must agree to receive pharmacological standard of care treatment to treat their MDD (as determined by the treating physician(s) based on clinical judgement and protocol recommendations) during the trial duration.
    - If the participant is taking any other type of psychotropic drugs, the dose of these drugs needs to be stable, where a stable dose of psychotropic drugs is defined as no changes in dose or type of e.g. antipsychotics or mood stabilizers for at least 6 weeks prior to baseline (if applicable).
    - The antidepressant should be at a stable dose for at least 4 weeks before baseline. No new antidepressant initiated 6 weeks or less before baseline. No psychotherapy initiated 4 weeks or less before baseline.
    - Able to communicate well, and to understand and comply with study requirements.
    - Se deberá obtener el consentimiento informado firmado antes de la participación en el estudio.
    - Participantes de ambos sexos con edades comprendidas entre los 18 y los 65 años (ambos inclusive) en la selección.
    - Participantes con diagnóstico de trastorno depresivo mayor (TDM) recurrente y un episodio depresivo mayor actual de al menos 8 semanas de duración según los criterios de la quinta edición del Manual diagnóstico y estadístico de los trastornos mentales (DSM-5) y confirmado mediante la M.I.N.I. (Mini International Neuropsychiatric Interview) y una evaluación clínica psiquiátrica adecuada en la selección.
    - Participantes con una puntuación de la MADRS >/= 24 en la selección y antes de la aleatorización el día 1.
    - No haber respondido a 2 o más tratamientos antidepresivos previos pero no más de 5, siempre que dos de los tratamientos que hayan fracasado sean dos antidepresivos diferentes y con una dosis y una duración adecuadas (>/= 6 semanas de duración y a las dosis definidas por el fármaco), según lo determinado en el Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ), basándose en el informe del paciente y en el historial psiquiátrico previo, según el criterio del investigador y según esté documentado además en los registros médicos. Los pacientes con antecedentes de fracaso del tratamiento con esketamina, ketamina o arketamina están excluidos.

    Por favor refiérase el protocolo para demas criterios.
    E.4Principal exclusion criteria
    - Current acute depressive episode lasting longer than two years continuously, or participants receiving electroconvulsive therapy (ECT), vagal nerve stimulation (VNS) or deep brain stimulation (DBS) within last year prior to screening.
    - Any prior or current diagnosis of MDD with psychotic features, bipolar disorder, schizophrenia, or schizoaffective disorder as obtained from M.I.N.I, Module C (Manic and Hypomanic Episodes) and Module K (Psychotic Disorders and Mood Disorders with Psychotic Features) assessed at screening.
    - Participants with acute alcohol or substance use disorder or withdrawal symptoms requiring detoxification, or participants who went through detoxification treatment (inpatient or outpatient) within 1 month before Screening. M.I.N.I. Module I (Alcohol Use Disorder) and Module J (Substance Use Disorder, Non-Alcohol) should be conducted at screening.
    - Participants with current borderline personality disorder Module Y (Borderline Personality Disorder) or antisocial personality disorder Module P (Antisocial Personality disorder) as obtained from M.I.N.I. assessed at Screening.
    - Current clinical diagnosis of autism, dementia, or intellectual disability.
    - Participants with a history of suicidal attempt or suicidal behaviour within last year prior to screening and participants presenting suicidal ideation with intent documented by C-SSRS by Yes response to Q4 or Q5 at screening or baseline.
    - Participants with evidence of significant renal insufficiency, indicated by an estimated glomerular filtration rate (eGFR) of < 40 mL/min/1.73 m2 at screening.
    - Use of other investigational drugs at the time of screening, or within 30 days or 5 half lives of screening, whichever is longer.
    - History of hypersensitivity to any of the study treatments or excipients or to drugs of similar mechanism of action (i.e. drugs that affect the NMDA receptor).
    - Active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active COVID-19 infection as per medical history and/or available medical records.
    - History of seizures. Note: childhood febrile seizures are not exclusionary.
    - Cardiac or cardiac repolarization abnormality
    - Resting QTcF >/=450 msec (male) or >/=460 msec (female) at screening or baseline
    - Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
    - Participant has mean systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at Screening or pre first dose on Day 1; or past history of hypertensive crisis.
    - History of hemorrhagic stroke or known cerebrovascular disorders (e.g. aneurysm or arteriovenous malformation) or known aneurysmal vascular disease in other location (e.g. aorta).
    - Pregnancy (including a positive human chorionic gonadotropin [hCG] test) or lactation at screening or baseline.
    - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of investigational drug.
    - Sexually active males unwilling to use a condom during intercourse while taking investigational drug and for 1 week after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of the investigational drug via seminal fluid to their partner. In addition, male participants should not donate sperm for the time period specified above.
    - Any other condition (e.g. known liver disease/liver dysfunction, active malignancy etc.) which in the opinion of the investigator would put the safety of the participant at risk, affect compliance or make the patient an unsuitable candidate for the study.

    See protocol for full exclusion criteria.
    - Pacientes con un episodio depresivo agudo actual con una duración superior a dos años de forma continuada o pacientes que hayan recibido terapia electroconvulsiva (TEC) o tratamiento de estimulación del nervio vago (ENV) o de estimulación cerebral profunda (ECP) durante el año anterior a la selección.
    - Cualquier diagnóstico previo o actual de TDM con características psicóticas, trastorno bipolar, esquizofrenia o trastorno esquizoafectivo determinado mediante el módulo C (episodios maníacos e hipomaníacos) y el módulo K (trastornos psicóticos y trastornos del estado de ánimo con características psicóticas) de la M.I.N.I. y evaluado en la selección.
    - Participantes con trastorno agudo por consumo de alcohol o uso de sustancias ilícitas o síntomas de abstinencia que requieran desintoxicación, o participantes que se hayan sometido a un tratamiento de desintoxicación (hospitalario o ambulatorio) durante el mes anterior a la selección. Se debe aplicar el módulo I (trastorno por consumo de alcohol) y el módulo J (trastorno por uso de sustancias ilícitas, excepto alcohol) de la M.I.N.I en la selección.
    - Participantes con trastorno límite de la personalidad o trastorno antisocial de la personalidad actuales determinados mediante el módulo Y (trastorno límite de la personalidad) y el módulo P (trastorno antisocial de la personalidad) de la M.I.N.I. en la selección.
    - Diagnóstico clínico actual de autismo, demencia o discapacidad intelectual.
    - Participantes con antecedentes de intento de suicidio o comportamiento suicida durante el año anterior a la selección y participantes que presenten ideación con intención documentada mediante la Columbia Suicide Severity Rating Scale (C-SSRS) en la que hayan respondido Sí a la pregunta 4 o la 5 en la selección o en la basal.
    - Uso de otros fármacos en investigación en el momento de la selección, o durante los 30 días o 5 vidas medias anteriores a la selección, aquello que sea más largo, o durante más tiempo si así lo exige la normativa local.
    - Embarazo (incluyendo un resultado positivo en la prueba de gonadotropina coriónica humana [hCG]) o lactancia en la selección o en la basal.
    - Virus de la hepatitis B (VHB), virus de la hepatitis C (VHC) o virus de la inmunodeficiencia humana (VIH) activos o infección por COVID-19 activa según la historia clínica o los registros médicos disponibles.
    - Intervalo QT en reposo corregido con la fórmula de Fridericia (QTcF) >/=450 milisegundos (ms) (hombres) o >/= 460 ms (mujeres) en la selección o en la basal.

    Por favor refiérase el protocolo para demas criterios.
    E.5 End points
    E.5.1Primary end point(s)
    MADRS total score at 24 hours after s.c. injection compared to baseline assessment
    Cambio respecto a la basal en la puntuación obtenida en la MADRS 24 horas después de una única inyección s.c.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours post dose from baseline
    24 horas después de la dosis desde la basal
    E.5.2Secondary end point(s)
    - Incidence and severity of treatment-emergent adverse events (TEAEs), including AEs of special interest; standard safety assessments such as vital signs, ECG, hematology, blood chemistry, urinalysis; Clinician-Administered Dissociative States Scale (CADSS) score, Modified Observer's Assessment of Alertness/Sedation (MOAA/S), C-SSRS, memory assessment using orientation questions, results of local tolerability assessments
    - PK properties of MIJ821 in plasma described by Area under the curve from time zero to time of last measurable concentration (AUClast), maximum plasma drug concentration (Cmax), time to reach maximum plasma concentration (Tmax) (parameters not limited).
    - MADRS total score at Day 8, 15, 22 and 29 visits compared to baseline
    - Dose-response relationship of MIJ821 with respect to change from baseline in MADRS total score at 24 hours after single s.c. injection
    - Exposure-response relationship of MIJ821 with respect to change from baseline in MADRS total score at 24 hours (Day 2)
    - Incidencia y gravedad de los eventos adversos emergentes del tratamiento (TEAE), incluidos los EA de especial interés; evaluaciones de seguridad estándar como signos vitales, ECG, hematología, química sanguínea, análisis de orina; Puntuación de la escala de estados disociativos administrada por el médico (CADSS), evaluación modificada del estado de alerta/sedación del observador (MOAA/S), C-SSRS, evaluación de la memoria mediante preguntas de orientación, resultados de las evaluaciones de tolerabilidad local.
    - Propiedades farmacocinéticas de MIJ821 en plasma descritas por Área bajo la curva desde el momento cero hasta el momento de la última concentración medible (AUClast), concentración máxima del fármaco en plasma (Cmax), tiempo para alcanzar la concentración máxima en plasma (Tmax) (parámetros no limitados).
    - Puntuación total de MADRS en las visitas de los días 8, 15, 22 y 29 en comparación con la basal.
    - Relación dosis-respuesta de MIJ821 con respecto al cambio desde el valor inicial en la puntuación total de MADRS a las 24 horas después de una sola administración s.c. inyección.
    - Relación exposición-respuesta de MIJ821 con respecto al cambio desde la basal en la puntuación total de MADRS a las 24 horas (Día 2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 hours post dose from baseline, Day 8, Day 15, Day 22 and Day 29
    24 horas después de la dosis desde el inicio, día 8, día 15, día 22 y día 29
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Japan
    United States
    Poland
    Spain
    Czechia
    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
    LPLV
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 56
    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
    Ninguno
    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 Decision2022-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-14
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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