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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2021-005992-38
    Trial protocol
    		 ES   PL  
    Global end of trial date
    28 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Dec 2024
    First version publication date
    12 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CMIJ821B12201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05454410
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Nov 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of MIJ821 (versus placebo) in treatment resistant depression (TRD) after single subcutaneous (s.c.) injection. Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial. Rescue medications were allowed and the use of these were documented in the medical records and in the electronic case report form (eCRF). Prohibited medication was administered as rescue medication if clinically warranted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Mar 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 3
    Country: Number of subjects enrolled
    Poland: 28
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    United States: 13
    Worldwide total number of subjects
    60
    EEA total number of subjects
    44
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    60
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All inclusion and exclusion criteria were checked during screening and on Day 1, prior to randomization.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MIJ821 10 mg
    Arm description
    		 Participants received a single dose of 10 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MIJ821
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a single dose of 10 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.

    Arm title
    		 MIJ821 4 mg
    Arm description
    		 Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MIJ821
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.

    Arm title
    		 MIJ821 1 mg
    Arm description
    		 Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MIJ821
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.

    Arm title
    		 Placebo
    Arm description
    		 Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.

    Number of subjects in period 1
    		MIJ821 10 mg MIJ821 4 mg MIJ821 1 mg Placebo
    Started
    15
    14
    14
    17
    Completed
    15
    14
    13
    16
    Not completed
    0
    0
    1
    1
         Consent withdrawn by subject
    -
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MIJ821 10 mg
    Reporting group description
    		 Participants received a single dose of 10 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.

    Reporting group title
    MIJ821 4 mg
    Reporting group description
    		 Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.

    Reporting group title
    MIJ821 1 mg
    Reporting group description
    		 Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.

    Reporting group values
    		 MIJ821 10 mg MIJ821 4 mg MIJ821 1 mg Placebo Total
    Number of subjects
    		 15 14 14 17 60
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 15 14 14 17 60
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.8 ( 12.36 ) 43.9 ( 11.29 ) 46.9 ( 9.73 ) 47.1 ( 12.05 ) -
    Sex/Gender, Customized
    Units: participants
        Male
    		 4 4 5 10 23
        Female
    		 11 10 9 7 37
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 15 13 12 17 57
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian / Japanese
    		 0 1 2 0 3
        Black or African American
    		 0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 3 3 0 8
        Not Hispanic or Latino
    		 13 11 11 17 52
        Unknown or Not Reported
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    MIJ821 10 mg
    Reporting group description
    		 Participants received a single dose of 10 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.

    Reporting group title
    MIJ821 4 mg
    Reporting group description
    		 Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.

    Reporting group title
    MIJ821 1 mg
    Reporting group description
    		 Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.

    Subject analysis set title
    Overall
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Pooled for all participants

    Primary: Change from Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score 24 Hours (Day 2) after Injection

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    End point title
    		 Change from Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score 24 Hours (Day 2) after Injection
    End point description
    The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 - 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS scores were collected electronically by qualified personnel.
    End point type
    Primary
    End point timeframe
    Baseline and 24 hours after SC injection
    End point values
    		 MIJ821 10 mg MIJ821 4 mg MIJ821 1 mg Placebo
    Number of subjects analysed
    15
    14
    14
    17
    Units: Scores on a Scale
        least squares mean (standard error)
    -14.1 ( 1.95 )
    -11.4 ( 2.04 )
    -8.4 ( 2.02 )
    -8.9 ( 1.82 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    MIJ821 10 mg v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -5.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -9.6
         upper limit
    		 -0.7
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    MIJ821 4 mg v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -2.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -7
         upper limit
    		 2.1
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    MIJ821 1 mg v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 ANCOVA
    Parameter type
    		 Median difference (net)
    Point estimate
    0.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 5.1

    Secondary: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESIs)

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    End point title
    		 Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESIs)
    End point description
    A TEAE was defined as an adverse event starting or worsening after the administration of study medication and up to the end of study visit. The following events were considered AESIs: • Dissociation • Sedation • Cardiovascular effects (Blood Pressure changes and QT interval prolongation on electrocardiogram [ECG]) • Respiratory effects (difficulty in breathing, changes in oxygen saturation) • Suicidality (suicidal ideation or behavior) • Memory gaps/amnesia • Cystitis or lower urinary tract adverse events
    End point type
    Secondary
    End point timeframe
    From Day 1 after SC injection to end of study, up to 29 Days
    End point values
    		 MIJ821 10 mg MIJ821 4 mg MIJ821 1 mg Placebo
    Number of subjects analysed
    15
    14
    14
    17
    Units: Percentage of participants
    number (not applicable)
        With at least one AE
    66.67
    42.86
    28.57
    41.18
        With at least one AESI
    60
    35.71
    14.29
    17.65
        Blood pressure increased
    0
    7.14
    7.14
    0
        Dissociation
    33.33
    14.29
    0
    11.76
        Derealization
    6.67
    0
    0
    0
        Vision blurred
    0
    0
    7.14
    0
        Amnesia
    6.67
    0
    0
    0
        Somnolence
    26.67
    7.14
    0
    5.88
        Sedation
    6.67
    7.14
    0
    0
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK) of MIJ821 in Plasma for Area Under the Curve from the Time of Dosing to the Time of the Last Measurable Concentration (AUClast)

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    End point title
    		 Pharmacokinetics (PK) of MIJ821 in Plasma for Area Under the Curve from the Time of Dosing to the Time of the Last Measurable Concentration (AUClast) [1]
    End point description
    Blood samples were collected at the indicated time points for PK analysis. AUClast was defined as the area under the curve from time zero to the last measurable concentration sampling time (tlast).
    End point type
    Secondary
    End point timeframe
    Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic parameters were only analyzed in the MIJ821 arms.
    End point values
    		 MIJ821 10 mg MIJ821 4 mg MIJ821 1 mg
    Number of subjects analysed
    15
    13
    13
    Units: h*ng/mL
        geometric mean (geometric coefficient of variation)
    231 ( 33.5 )
    89.5 ( 45.7 )
    5.92 ( 85.1 )
    No statistical analyses for this end point

    Secondary: PK of MIJ821 in Plasma for Maximum Serum Concentration (Cmax)

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    End point title
    		 PK of MIJ821 in Plasma for Maximum Serum Concentration (Cmax) [2]
    End point description
    Blood samples were collected at the indicated time points for PK analysis. Cmax was defined as the maximum (peak) observed plasma drug concentration after single dose administration.
    End point type
    Secondary
    End point timeframe
    Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic parameters were only analyzed in the MIJ821 arms.
    End point values
    		 MIJ821 10 mg MIJ821 4 mg MIJ821 1 mg
    Number of subjects analysed
    15
    13
    13
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    42.7 ( 37.2 )
    17.5 ( 46.7 )
    2.32 ( 55.4 )
    No statistical analyses for this end point

    Secondary: PK of MIJ821 in Plasma for Time to Maximum Drug Concentration (Tmax)

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    End point title
    		 PK of MIJ821 in Plasma for Time to Maximum Drug Concentration (Tmax) [3]
    End point description
    Blood samples were collected at the indicated time points for PK analysis. Tmax was defined as the time to reach maximum (peak) plasma drug concentration after single dose administration (time).
    End point type
    Secondary
    End point timeframe
    Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic parameters were only analyzed in the MIJ821 arms.
    End point values
    		 MIJ821 10 mg MIJ821 4 mg MIJ821 1 mg
    Number of subjects analysed
    15
    14
    14
    Units: hour (h)
        median (full range (min-max))
    0.750 (0.333 to 2.00)
    0.500 (0.150 to 1.00)
    0.500 (0.167 to 0.783)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the MADRS Total Scores at Day 8, 15, 22 and 29 Visits

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    End point title
    		 Change from Baseline in the MADRS Total Scores at Day 8, 15, 22 and 29 Visits
    End point description
    The MADRS (SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 - 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS scores were collected electronically by qualified personnel.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 8, 15, 22 and 29
    End point values
    		 MIJ821 10 mg MIJ821 4 mg MIJ821 1 mg Placebo
    Number of subjects analysed
    15
    14
    14
    17
    Units: Scores on a Scale
    least squares mean (standard error)
        Change from Baseline (Day 8) n=15,14,14,17
    -15.3 ( 2.0 )
    -9.9 ( 2.1 )
    -8.2 ( 2.0 )
    -7.4 ( 1.8 )
        Change from Baseline (Day 15) n=14,13,14,17
    -14.0 ( 2.2 )
    -8.5 ( 2.2 )
    -11.0 ( 2.2 )
    -7.7 ( 2.0 )
        Change from Baseline (Day 22) n=14,14,13,17
    -14.9 ( 2.2 )
    -10.7 ( 2.3 )
    -9.7 ( 2.3 )
    -7.0 ( 2.0 )
        Change from Baseline (Day 29) n=14,14,13,16
    -14.9 ( 2.3 )
    -12.7 ( 2.4 )
    -10.7 ( 2.4 )
    -7.0 ( 2.1 )
    No statistical analyses for this end point

    Secondary: Dose-response (DR) Relationship of MIJ821 with Respect to Change from Baseline in MADRS Total Score at 24 Hours after Single SC injection

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    End point title
    		 Dose-response (DR) Relationship of MIJ821 with Respect to Change from Baseline in MADRS Total Score at 24 Hours after Single SC injection
    End point description
    The multiple comparison procedure - modelling (MCP-Mod) approach was an integrated approach used to investigate DR relationships, while confirming efficacy of the test product based on hypothesis testing. A set of candidate models was tested using Multiple Comparison Procedures (MCP) that preserve the family-wise error rate (FWER). Efficacy via DR was established when at least one of the model tests was significant.
    End point type
    Secondary
    End point timeframe
    Baseline up to 24 Hours
    End point values
    		 MIJ821 10 mg MIJ821 4 mg MIJ821 1 mg Placebo
    Number of subjects analysed
    15
    14
    14
    17
    Units: Scores on a Scale
        least squares mean (standard error)
    -14.1 ( 1.95 )
    -11.4 ( 2.04 )
    -8.4 ( 2.02 )
    -8.9 ( 1.82 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    MCP-Mod was used to check if there was a DR relationship between the change from baseline to 24 hours in MADRS total score and the doses received. The Least squares means under the primary estimand were used to test the null hypothesis of a flat DR relationship at a one-sided significance level of 5% against the alternative hypothesis of a non-flat DR curve. Six candidate DR curves were used to derive the optimal model contrasts for the multiple contrast tests. A monotone DR was assumed.
    Comparison groups
    MIJ821 10 mg v MIJ821 4 mg v MIJ821 1 mg v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0242 [4]
    Method
    		 Multiple contrast test
    Confidence interval
    Notes
    [4] - P-values were adjusted for multiple comparisons.

    Secondary: Exposure-response Relationship of MIJ821 with Respect to Change from Baseline in MADRS Total Score

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    End point title
    		 Exposure-response Relationship of MIJ821 with Respect to Change from Baseline in MADRS Total Score
    End point description
    The exposure-response (ER) relationship was investigated considering PK exposure parameters (AUClast and Cmax) and the change from baseline MADRS score derived at 4 h and 24 h after injection and Day 8, Day 15, Day 22 and Day 29 during the follow-up. The emax model or sigmoid emax model were planned to be fitted for the change from baseline at each follow up visit and the PK exposure parameters, Cmax and AUClast. If the model converges, parameters estimated from the Sigmoid emax model are: the placebo effect E0, EC50, Emax and the hill parameter.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 2, 15, 22 and 29
    End point values
    		 Overall
    Number of subjects analysed
    41
    Units: parameter estimate from model
        ER Relationship Cmax: placebo effect E0
    999
        ER Relationship Cmax: EC50
    999
        ER Relationship Cmax: Emax
    999
        ER Relationship Cmax: hill parameter
    999
        ER Relationship AUClast: placebo effect E0
    999
        ER Relationship AUClast: EC50
    999
        ER Relationship AUClast: Emax
    999
        ER Relationship AUClast: hill parameter
    999
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
    Adverse event reporting additional description
    The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    MIJ821 10mg
    Reporting group description
    		 Participants received a single dose of 10 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.

    Reporting group title
    MIJ821 4mg
    Reporting group description
    		 Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.

    Reporting group title
    MIJ821 1mg
    Reporting group description
    		 Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.

    Reporting group title
    All MIJ821
    Reporting group description
    		 All MIJ821 Dosages

    Reporting group title
    All Subjects
    Reporting group description
    		 All Subjects included in the Safety Analysis Set

    Serious adverse events
    		 MIJ821 10mg MIJ821 4mg MIJ821 1mg Placebo All MIJ821 All Subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 43 (0.00%)
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MIJ821 10mg MIJ821 4mg MIJ821 1mg Placebo All MIJ821 All Subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 15 (66.67%)
    6 / 14 (42.86%)
    4 / 14 (28.57%)
    7 / 17 (41.18%)
    20 / 43 (46.51%)
    27 / 60 (45.00%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    2 / 43 (4.65%)
    2 / 60 (3.33%)
         occurrences all number
    0
    1
    1
    0
    2
    2
    Heart rate increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    1 / 43 (2.33%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 43 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Nervous system disorders
    Sedation
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    2 / 43 (4.65%)
    2 / 60 (3.33%)
         occurrences all number
    1
    1
    0
    0
    2
    2
    Headache
         subjects affected / exposed
    3 / 15 (20.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    3 / 17 (17.65%)
    4 / 43 (9.30%)
    7 / 60 (11.67%)
         occurrences all number
    3
    0
    1
    4
    4
    8
    Dizziness
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    1 / 43 (2.33%)
    2 / 60 (3.33%)
         occurrences all number
    1
    0
    0
    1
    1
    2
    Amnesia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 43 (2.33%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    Somnolence
         subjects affected / exposed
    4 / 15 (26.67%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    5 / 43 (11.63%)
    6 / 60 (10.00%)
         occurrences all number
    4
    1
    0
    1
    5
    6
    Tension headache
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 43 (2.33%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 43 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Injection site erythema
         subjects affected / exposed
    3 / 15 (20.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    3 / 43 (6.98%)
    3 / 60 (5.00%)
         occurrences all number
    3
    0
    0
    0
    3
    3
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    1 / 43 (2.33%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 43 (2.33%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    Nausea
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    2 / 17 (11.76%)
    0 / 43 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 43 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 43 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    1 / 43 (2.33%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    Dissociation
         subjects affected / exposed
    5 / 15 (33.33%)
    2 / 14 (14.29%)
    0 / 14 (0.00%)
    2 / 17 (11.76%)
    7 / 43 (16.28%)
    9 / 60 (15.00%)
         occurrences all number
    5
    2
    0
    2
    7
    9
    Derealisation
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 43 (2.33%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    Depression
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    1 / 43 (2.33%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    Infections and infestations
    Gastrointestinal infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 43 (2.33%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    Pharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 43 (2.33%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    Tooth infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 43 (2.33%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 43 (2.33%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    0
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 May 2022
    Amendment 01 includes the following: The purpose of this protocol amendment was to clarify that the End of-Study visit (Day 29) was the last study visit for ensuring safety follow-up and thus a safety follow-up call at Day 31 was not required while taking into consideration the pharmacokinetic profile of MIJ821 (five times the apparent terminal elimination half-life of MIJ821). The protocol was amended to clarify that in case of extended safety monitoring for adverse events on Day 1, between 4 hours and 24 hours post-dose, additional safety tests or measures were required, including but not limited to, unscheduled PK samples. The recall periods for the MADRS and the Clinical Global Impression - Severity (CGI-S) scale were added in order to adequately assess efficacy at the 4 hour-time point on Day 1. In addition, the recall period of the MADRS used at screening had specified: “Last 7 days with euthymic baseline”. The recall period of the Clinician-Administered Dissociative States Scale (CADSS) was also added. The recall period of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the first study visit was updated to reflect that this version assessed suicidal ideation and suicidal behavior during the participant's last one year and during a predefined period of one month.
    04 Nov 2022
    Amendment 02 includes the following: The purpose of this protocol amendment was to replace the Mini International Neuropsychiatric Interview (M.I.N.I), used at screening to assess whether the diagnostic criteria was met, with an equivalent validated instrument: the Structured Clinical Interview for DSM-5 Disorders (SCID-5). The M.I.N.I was not to be used in this trial due to difficulties related to copyright license agreement's activities, which were not to be overcome in a timely manner.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    For support, Contact us.
    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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