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    Clinical Trial Results:
    Interventional, randomized, double-blind, active-controlled study of the efficacy of Lu AF35700 in patients with early-in-disease or late-in-disease treatment-resistant schizophrenia

    Summary
    EudraCT number
    		 2017-000788-34
    Trial protocol
    		 BG   GB  
    Global end of trial date
    05 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2020
    First version publication date
    05 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    17303A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03230864
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark, 2500
    Public contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, 0045 36301311, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, 0045 36301311, LundbeckClinicalTrials@lundbeck.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
    05 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Feb 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study evaluates the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in patients with early-in-disease (ED) or late-in-disease (LD) treatment-resistant schizophrenia (TRS)
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH Good Clinical Practice (1996).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Jul 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Bulgaria: 44
    Country: Number of subjects enrolled
    Japan: 9
    Country: Number of subjects enrolled
    Russian Federation: 40
    Country: Number of subjects enrolled
    United States: 24
    Worldwide total number of subjects
    119
    EEA total number of subjects
    46
    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)
    116
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who met each of the inclusion and none of the exclusion criteria were eligible to participate in the study.

    Period 1
    Period 1 title
    Prospective Confirmation (PC) Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PC Period - Risperidone
    Arm description
    		 Single (patient)-blinded treatment period with risperidone for 6 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Risperidone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4-6 mg/day, encapsulated tablets, orally

    Arm title
    		 PC Period - Olanzapine
    Arm description
    		 Single (patient)-blinded treatment period with olanzapine for 6 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olazapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15-20 mg/day, encapsulated tablets, orally

    Number of subjects in period 1
    		PC Period - Risperidone PC Period - Olanzapine
    Started
    68
    51
    Completed
    36
    32
    Not completed
    32
    19
         Consent withdrawn by subject
    4
    1
         Adverse event, non-fatal
    3
    -
         Study Personnel Decision
    1
    -
         Sponsor Decision
    9
    9
         Did not fulfill rand criteria DBT
    14
    5
         Protocol deviation
    1
    2
         Lack of efficacy
    -
    2
    Period 2
    Period 2 title
    Double-blind Treatment (DBT) Period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DBT, Lu AF35700 10 mg
    Arm description
    		 Eligible patients from PC Period (based on criteria to which invetsigator and patient are blinded), will be randomly assigned (1:1) double-blind treatment in DBT Period, 8 weeks. Lu AF35700: 10 mg/day, encapsulated tablets, orally
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lu AF35700
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lu AF35700 10 mg/day, encapsulated tablets, orally

    Arm title
    		 DBT, Continued Treatment
    Arm description
    		 Eligible patients from PC Period (based on crietria to which investigator and patient are blinded), will be randomly assigned (1:1) double-blind treatment in DBT Period, 8 weeks. Patients in this arm will continue with the same treatment and dose as at last visit of PC Period. Risperidone: 4-6 mg/day, encapsulated tablets, orally. Olanzapine: 15-20 mg/day, encapsulated tablets, orally
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olazapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15-20 mg/day, encapsulated tablets, orally

    Investigational medicinal product name
    Risperidone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4-6 mg/day, encapsulated tablets, orally

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: It is correct that not all the patients that enrolled the study started the double bind treatment period which explains that the numbers are not the same.
    Number of subjects in period 2 [2]
    		DBT, Lu AF35700 10 mg DBT, Continued Treatment
    Started
    35
    33
    Completed
    27
    31
    Not completed
    8
    2
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    5
    1
         Sponsor Decision
    2
    -
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: It is correct that not all the patients that enrolled the study started the double bind treatment period which explains that the numbers are not the same.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DBT, Lu AF35700 10 mg
    Reporting group description
    		 Eligible patients from PC Period (based on criteria to which invetsigator and patient are blinded), will be randomly assigned (1:1) double-blind treatment in DBT Period, 8 weeks. Lu AF35700: 10 mg/day, encapsulated tablets, orally

    Reporting group title
    DBT, Continued Treatment
    Reporting group description
    		 Eligible patients from PC Period (based on crietria to which investigator and patient are blinded), will be randomly assigned (1:1) double-blind treatment in DBT Period, 8 weeks. Patients in this arm will continue with the same treatment and dose as at last visit of PC Period. Risperidone: 4-6 mg/day, encapsulated tablets, orally. Olanzapine: 15-20 mg/day, encapsulated tablets, orally

    Reporting group values
    		 DBT, Lu AF35700 10 mg DBT, Continued Treatment Total
    Number of subjects
    		 35 33 68
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.9 ( 11.26 ) 42 ( 12.26 ) -
    Gender categorical
    Units: Subjects
        Female
    		 15 17 32
        Male
    		 20 16 36
    Race
    Units: Subjects
        Asian
    		 3 3 6
        Black or African American
    		 0 2 2
        White
    		 31 27 58
        Other
    		 1 1 2
    PANNS Total score
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 102.3 ( 12 ) 101.6 ( 11.95 ) -
    CGI-S score
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 4.8 ( 0.57 ) 4.9 ( 0.55 ) -

    End points

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    End points reporting groups
    Reporting group title
    PC Period - Risperidone
    Reporting group description
    		 Single (patient)-blinded treatment period with risperidone for 6 weeks

    Reporting group title
    PC Period - Olanzapine
    Reporting group description
    		 Single (patient)-blinded treatment period with olanzapine for 6 weeks
    Reporting group title
    DBT, Lu AF35700 10 mg
    Reporting group description
    		 Eligible patients from PC Period (based on criteria to which invetsigator and patient are blinded), will be randomly assigned (1:1) double-blind treatment in DBT Period, 8 weeks. Lu AF35700: 10 mg/day, encapsulated tablets, orally

    Reporting group title
    DBT, Continued Treatment
    Reporting group description
    		 Eligible patients from PC Period (based on crietria to which investigator and patient are blinded), will be randomly assigned (1:1) double-blind treatment in DBT Period, 8 weeks. Patients in this arm will continue with the same treatment and dose as at last visit of PC Period. Risperidone: 4-6 mg/day, encapsulated tablets, orally. Olanzapine: 15-20 mg/day, encapsulated tablets, orally

    Primary: Change From Randomization to Week 8 in Positive and Negative Syndrome Scale (PANNS) Total Score

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    End point title
    		 Change From Randomization to Week 8 in Positive and Negative Syndrome Scale (PANNS) Total Score
    End point description
    PANSS total score administered by the investigator. It included a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A negative score indicates an improvement compared to Randomization.
    End point type
    Primary
    End point timeframe
    From Randomization to Week 8
    End point values
    		 DBT, Lu AF35700 10 mg DBT, Continued Treatment
    Number of subjects analysed
    27
    31
    Units: units on a scale
        least squares mean (standard error)
    -4.71 ( 2.22 )
    -10.19 ( 2.16 )
    Statistical analysis title
    		 Superiority Lu AF35700 10mg vs Continued Treatment
    Statistical analysis description
    Only patients randomized to receive double blind treatment in the DBT Period are analyzed. Overall Number of Participants Analyzed in the FAS with a week 8 observation
    Comparison groups
    DBT, Lu AF35700 10 mg v DBT, Continued Treatment
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0809 [2]
    Method
    		 Mixed Model Repeated Measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 11.65
    Notes
    [1] - The mean changes from randomization in PANNS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period Treatment-by-week interaction, and the continuous covariates of Randomization score and Randomizaion-score-by-week interaction with an unstructured covariance structure to model the within-patient errors
    [2] - Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied, since all p-values >0.05

    Secondary: Change From Randomization to Week 8 in Global Clinical Impression – Severity of Illness (CGI-S) Score

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    End point title
    		 Change From Randomization to Week 8 in Global Clinical Impression – Severity of Illness (CGI-S) Score
    End point description
    CGI-S provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening
    End point type
    Secondary
    End point timeframe
    From randomization to week 8
    End point values
    		 DBT, Lu AF35700 10 mg DBT, Continued Treatment
    Number of subjects analysed
    27
    31
    Units: units on a scale
        least squares mean (standard error)
    -0.18 ( 0.12 )
    -0.37 ( 0.11 )
    No statistical analyses for this end point

    Secondary: Change From Randomization to Week 8 in 16-item Negative Symptom Assessment (NSA-16 Total) Score

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    End point title
    		 Change From Randomization to Week 8 in 16-item Negative Symptom Assessment (NSA-16 Total) Score
    End point description
    16 items arranged in 5 subdomains: communication dysfunction (items 1 to 4), emotional/affective dysfunction (items 5 to 7), dysfunction in sociality (items 8 to 10), motivational/hedonic dysfunction (items 11 to 14), and reduced psychomotor activity (items 15 and 16), and a Global Negative Symptom Rating. NSA-16 items are rated on a 6-point scale from 1 (behaviour is normal) to 6 (behaviour severely reduced), and a score of 9 if the item is not-rateable. The Global Negative Symptom Rating is rated from 1 (no evidence of symptoms) to 7 (extremely severe symptoms). The 16 items are summed to yield a total score ranging from 16 to 96 and the global rating ranges from 1 to 7.
    End point type
    Secondary
    End point timeframe
    From randomization to Week 8
    End point values
    		 DBT, Lu AF35700 10 mg DBT, Continued Treatment
    Number of subjects analysed
    27
    31
    Units: units on a scale
        least squares mean (standard error)
    -2.99 ( 1.64 )
    -3.14 ( 1.58 )
    No statistical analyses for this end point

    Secondary: Change From Randomization to Week 8 in PANSS Negative Factor Score (Marder Negative Score)

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    End point title
    		 Change From Randomization to Week 8 in PANSS Negative Factor Score (Marder Negative Score)
    End point description
    The PANSS Negative Factor score is a subset of the PANSS assessing negative symptoms of schizophrenia. The factor consist of the seven items: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity, motor retardation, and active social avoidance which are each rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Negative Factor score (7 items) range from 7 to 49 with a higher score indicating greater severity of symptoms.
    End point type
    Secondary
    End point timeframe
    From Randomization to Week 8
    End point values
    		 DBT, Lu AF35700 10 mg DBT, Continued Treatment
    Number of subjects analysed
    27
    31
    Units: units on a scale
        least squares mean (standard error)
    -1.51 ( 0.77 )
    -1.74 ( 0.75 )
    No statistical analyses for this end point

    Secondary: Response

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    End point title
    		 Response
    End point description
    End point type
    Secondary
    End point timeframe
    From randomization to Week 8
    End point values
    		 DBT, Lu AF35700 10 mg DBT, Continued Treatment
    Number of subjects analysed
    27
    31
    Units: participants
    6
    13
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    20 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Prospective Confirmation (PC) Period - Risperidone
    Reporting group description
    		 -

    Reporting group title
    PC Period - Olanzapine
    Reporting group description
    		 -

    Reporting group title
    Double Blind Treatment (DBT) Period - Lu AF35700 1
    Reporting group description
    		 -

    Reporting group title
    DBT - Period Lu AF35700 20 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Prospective Confirmation (PC) Period - Risperidone PC Period - Olanzapine Double Blind Treatment (DBT) Period - Lu AF35700 1 DBT - Period Lu AF35700 20 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 68 (1.47%)
    1 / 51 (1.96%)
    0 / 35 (0.00%)
    0 / 33 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Prospective Confirmation (PC) Period - Risperidone PC Period - Olanzapine Double Blind Treatment (DBT) Period - Lu AF35700 1 DBT - Period Lu AF35700 20 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 68 (25.00%)
    3 / 51 (5.88%)
    9 / 35 (25.71%)
    8 / 33 (24.24%)
    Investigations
    Weight increased
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 51 (0.00%)
    1 / 35 (2.86%)
    3 / 33 (9.09%)
         occurrences all number
    1
    0
    1
    3
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    4 / 68 (5.88%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    6 / 68 (8.82%)
    1 / 51 (1.96%)
    4 / 35 (11.43%)
    1 / 33 (3.03%)
         occurrences all number
    7
    1
    4
    1
    Insomnia
         subjects affected / exposed
    4 / 68 (5.88%)
    0 / 51 (0.00%)
    1 / 35 (2.86%)
    2 / 33 (6.06%)
         occurrences all number
    4
    0
    1
    2
    Schizophrenia
         subjects affected / exposed
    1 / 68 (1.47%)
    2 / 51 (3.92%)
    2 / 35 (5.71%)
    1 / 33 (3.03%)
         occurrences all number
    1
    2
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Apr 2018
    PA2: This amendment has been prepared to revise the definition of patients with early-in-disease (ED) treatment-resistant schizophrenia (TRS) in protocol edition 2.0. The definition of ED TRS has been extended to include patients with schizophrenia first diagnosed <10 years prior to the Screening Visit, who will have failed at least 2 adequate treatment trials with an antipsychotic drug. The patient cohort in Study 17303A will now be continuous for all eligible patients, irrespective of the number of years prior to the Screening Visit when they were first diagnosed with schizophrenia. This more inclusive cohort will allow for more thorough analysis of the effects of Lu AF35700 in patients with ED TRS, without missing information from patients who are designated to have TRS but were diagnosed with schizophrenia between 5 to 10 years prior to the Screening Visit. The proposed analyses will include patients with ED TRS or LD TRS, as well as patients with TRS first diagnosed ≤5 years prior to the Screening Visit. In addition, this amendment has been prepared to make some clarifications and elaborations to protocol edition 2.0.
    07 Sep 2018
    PA3: This amendment has been prepared to increase the statistical power and geographic presence of the study to allow the use of the study data for confirmatory purposes. The number of patients to be randomized in the study has been increased and the targeted ratio of patients with early-in-disease (ED) treatment-resistant schizophrenia (TRS) to patients with late-in-disease (LD) TRS has been revised. The target ratio of patients with ED TRS versus LD TRS has been adjusted from 2:1 to 1:2. A ratio of 1:2 will more closely approximate the ratio of patients with ED versus LD TRS patients in the other ongoing phase III efficacy Study 16159A and 1:2 is also the ratio generally prevalent in the disease community. In addition, the change in target ratio is expected to facilitate recruitment. The objectives of the trial remain the same despite the change in sample size and ratio. The number of patients to be randomized in the study has been increased from 150 to 490. With the change in ratio of patients with ED TRS versus LD TRS (from 2:1 to 1:2) Study 17303A is aligned with Study 16159A and the assumptions regarding treatment effect size from Study 16159A has been applied to the sample size recalculation for Study 17303A. Further, the sample size recalculation was done to increase (from 80% to more than 90%) the power of the study. With this amendment to the protocol, the study may serve as a second confirmatory study in the development program for Lu AF35700 for a TRS indication. Study 17303A has from the beginning used the same study methodology as Study 16159A with similar inclusion and exclusion criteria. For its entire duration, Study 17303A has been conducted to the same high quality standard as Study 16159A and will continue to be so after the enlargement of the study.

    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.
    The study was terminated early and hence the statistical analysis was conducted on a smaller sample size than originally planned
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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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