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    Clinical Trial Results:
    A randomized, double-blind, multicenter, 24-week study of subcutaneous secukinumab to assess anti-interleukin-17A treatment in plaque psoriasis patients with coexisting non-alcoholic fatty liver disease (pINPOINt).

    Summary
    EudraCT number
    2019-003168-37
    Trial protocol
    DE  
    Global end of trial date
    23 Jul 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Jun 2022
    First version publication date
    26 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457ADE15
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04237116
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    EudraCT: 2019-003168-37
    Sponsors
    Sponsor organisation name
    Novartis Pharma GmbH
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma GmbH, 1 (862) 778-8300, novartis.email@novartis.com
    Scientific contact
    Study Director, Novartis Pharma GmbH, 1 (862) 778-8300, novartis.email@novartis.com
    Sponsor organisation name
    Novartis Pharma GmbH
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma GmbH, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma GmbH, 41 613241111, novartis.email@novartis.com
    Sponsor organisation name
    Novartis Pharma GmbH
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma GmbH, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma GmbH, 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
    12 Apr 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jul 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary study objective was to demonstrate superiority of secukinumab compared with placebo in patients with moderate to severe chronic plaque-type psoriasis and non-alcoholic fatty liver disease (NAFLD) with respect to PASI90 response at Week 12.
    Protection of trial subjects
    This 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.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Feb 2020
    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
    Germany: 8
    Country: Number of subjects enrolled
    Spain: 2
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This trial had 10 participants at 7 sites in Germany and one site in Spain. 8 in Germany and 2 in Spain. Patients who were still in the study when the sponsor terminated the study were counted as 'non-completers'

    Pre-assignment
    Screening details
    This study was prematurely discontinued after the enrollment of 10 patients, because the recruitment was too slow to achieve the planned number of patients within a reasonable time frame. No safety issues led to the decision to terminate the study prematurely.

    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
    Investigator, Monitor, Subject, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Investigational Arm - secukinumab
    Arm description
    secukinumab 300mg s.c. weekly in first 4 weeks, followed by q4w up to Week 20; and placebo 300mg s.c. at weeks 13, 14 and 15 to maintain the blind
    Arm type
    Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg s.c. (in 2 × 150 mg PFS)

    Arm title
    Control Arm - placebo
    Arm description
    placebo 300 mg s.c. weekly in first 4 weeks, followed by q4w up to Week 8; and secukinumab 300 mg s.c. weekly for 4 weeks starting at Week 12, followed by q4w up to Week 20
    Arm type
    Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    placebo
    Other name
    reference therapy
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg s.c. (in 2 × 150 mg PFS)

    Number of subjects in period 1
    Investigational Arm - secukinumab Control Arm - placebo
    Started
    7
    3
    Completed
    3
    1
    Not completed
    4
    2
         Adverse event, non-fatal
    -
    1
         Study terminated by Sponsor
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Investigational Arm - secukinumab
    Reporting group description
    secukinumab 300mg s.c. weekly in first 4 weeks, followed by q4w up to Week 20; and placebo 300mg s.c. at weeks 13, 14 and 15 to maintain the blind

    Reporting group title
    Control Arm - placebo
    Reporting group description
    placebo 300 mg s.c. weekly in first 4 weeks, followed by q4w up to Week 8; and secukinumab 300 mg s.c. weekly for 4 weeks starting at Week 12, followed by q4w up to Week 20

    Reporting group values
    Investigational Arm - secukinumab Control Arm - placebo Total
    Number of subjects
    7 3 10
    Age Categorical
    Units: Participants
        <=18 years
    0 0 0
        Between 18 and 65 years
    7 3 10
        >=65 years
    0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    41.6 ± 11.8 32.0 ± 16.8 -
    Sex: Female, Male
    Units: Participants
        Female
    4 0 4
        Male
    3 3 6
    Race/Ethnicity, Customized
    Units: Subjects
        White
    7 3 10
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Full Analysis Set (FAS): Comprised all patients to whom study treatment/reference treatment had been assigned by randomization. According to the ITT principle, patients were analyzed according to the treatment they have been assigned to during the randomization procedure. As RAS and FAS populations were identical no separate analysis of the RAS population was performed.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Safety Set (SAF): Included all patients who received at least one dose of study treatment/reference treatment. Patients were analyzed according to the study treatment received, where "treatment received" was defined as the randomized treatment, if the patient took at least one dose of that treatment, or the first treatment received, if the randomized treatment was never received.

    Subject analysis sets values
    Full Analysis Set Safety Set
    Number of subjects
    10
    10
    Age Categorical
    Units: Participants
        <=18 years
    0
    0
        Between 18 and 65 years
    10
    10
        >=65 years
    0
    0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    38.7 ± 13.3
    38.7 ± 13.3
    Sex: Female, Male
    Units: Participants
        Female
    4
    4
        Male
    6
    6
    Race/Ethnicity, Customized
    Units: Subjects
        White
    10
    10

    End points

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    End points reporting groups
    Reporting group title
    Investigational Arm - secukinumab
    Reporting group description
    secukinumab 300mg s.c. weekly in first 4 weeks, followed by q4w up to Week 20; and placebo 300mg s.c. at weeks 13, 14 and 15 to maintain the blind

    Reporting group title
    Control Arm - placebo
    Reporting group description
    placebo 300 mg s.c. weekly in first 4 weeks, followed by q4w up to Week 8; and secukinumab 300 mg s.c. weekly for 4 weeks starting at Week 12, followed by q4w up to Week 20

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Full Analysis Set (FAS): Comprised all patients to whom study treatment/reference treatment had been assigned by randomization. According to the ITT principle, patients were analyzed according to the treatment they have been assigned to during the randomization procedure. As RAS and FAS populations were identical no separate analysis of the RAS population was performed.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Safety Set (SAF): Included all patients who received at least one dose of study treatment/reference treatment. Patients were analyzed according to the study treatment received, where "treatment received" was defined as the randomized treatment, if the patient took at least one dose of that treatment, or the first treatment received, if the randomized treatment was never received.

    Primary: Mean and SD Change from baseline of PASI score up to week 12

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    End point title
    Mean and SD Change from baseline of PASI score up to week 12 [1]
    End point description
    Psoriasis Area and Severity Index (PASI) 90 response is defined as ≥ 90% improvement (reduction) in PASI score compared to The primary analysis was planned to be performed comparing treatments with respect to the primary efficacy variable in a logistic regression model. It was planned to present the Odds Ratio and its 95%-confidence interval and p-value. The planned null hypothesis to be rejected was that the Odds Ratio of a PASI90 response for patients with secukinumab vs. patients with placebo is ≥1 after 12 weeks. Due to the premature study termination and the limited number of treated patients with available data (7 patients in the secukinumab group and 3 patients in the placebo group), the extent of the originally planned statistical analyses of efficacy data was limited to descriptive summaries (absolute values per visit and changes from baseline; presented as mean and standard deviation) for the PASI score. No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    12 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: NO STATISTICAL ANALYSIS WAS PLANNED.
    End point values
    Investigational Arm - secukinumab Control Arm - placebo
    Number of subjects analysed
    7
    3
    Units: Mean
    arithmetic mean (standard deviation)
        Baseline
    15.7 ± 4.22
    15.9 ± 3.39
        Week 12
    0.8 ± 1.14
    13.4 ± 0.35
    No statistical analyses for this end point

    Secondary: Serum Alanine Aminotransferase (ALT) level up to week 12

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    End point title
    Serum Alanine Aminotransferase (ALT) level up to week 12
    End point description
    ALT is an enzyme that the liver releases when it becomes inflamed or damaged. ALT level measures liver function Parameter. Normal range of values for ALT is about 7 to 56 units per liter (U/L). Higher levels of ALT in the blood indicate more liver problems. Due to the premature study termination and the limited number of treated patients with available data (7 patients in the secukinumab group and 3 patients in the placebo group), the extent of the originally planned statistical analyses of efficacy data was limited to descriptive summaries (absolute values per visit and changes from baseline; presented as mean and standard deviation) for the ALT score. No statistical analysis was planned for this secondary outcome.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    Investigational Arm - secukinumab Control Arm - placebo
    Number of subjects analysed
    7
    3
    Units: U/L
    arithmetic mean (standard deviation)
        Baseline
    60.5 ± 35.73
    89.0 ± 15.56
        Week 12
    43.3 ± 12.76
    85.5 ± 20.51
    No statistical analyses for this end point

    Secondary: Mean and SD of DLQI up to week 12

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    End point title
    Mean and SD of DLQI up to week 12
    End point description
    Dermatology Life Quality Index (DLQI) is calculated by summing the score of each domain resulting in a maximum of 30 and a minimum of 0. The higher the score, the more Quality of Life was impaired. Meaning of DLQI Scores: 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20= very large effect on patient's life, 21-30 = extremely large effect on patient's life. Due to the premature study termination and the limited number of treated patients with available data (7 patients in the secukinumab group and 3 patients in the placebo group), the extent of the originally planned statistical analyses of efficacy data was limited to descriptive summaries (absolute values per visit and changes from baseline; presented as mean and standard deviation) for DLQI scores. No statistical analysis was planned for this secondary outcome.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    Investigational Arm - secukinumab Control Arm - placebo
    Number of subjects analysed
    7
    3
    Units: Mean
    arithmetic mean (standard deviation)
        Baseline
    11.3 ± 5.56
    8.0 ± 8.49
        Week 12
    0.3 ± 0.50
    7.0 ± 8.49
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 12 weeks
    Adverse event reporting additional description
    AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 12 weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Secukinumab 300mg
    Reporting group description
    Secukinumab 300mg

    Reporting group title
    Placebo
    Reporting group description
    Placebo

    Serious adverse events
    Secukinumab 300mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Secukinumab 300mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 7 (57.14%)
    2 / 3 (66.67%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 3 (33.33%)
         occurrences all number
    1
    1
    Low density lipoprotein increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Urinary sediment abnormal
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Urine analysis abnormal
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 3 (33.33%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Psoriasis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    Oral herpes
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jun 2020
    The main purpose of this amendment is to allow for participation of study sites in Spain and to correct inconsistencies. Additionally, an exclusion criterion was modified to exclude latent tuberculosis patients without completed tuberculosis treatment prior to screening as this treatment may affect liver function parameters that are relevant to secondary endpoints

    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 premature termination and limited number of treated patients the extent of originally planned statistical analyses of efficacy was limited to descriptive summaries for the PASI score, ALT values, and DLQI scores
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