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    Clinical Trial Results:
    A randomized, double blind, multicenter study assessing short (16 weeks) and long term efficacy (up to 1 year), safety, and tolerability of sub cutaneous secukinumab in subjects of body weight 90 kg or higher with moderate to severe chronic plaque type psoriasis

    Summary
    EudraCT number
    		 2015-004620-60
    Trial protocol
    		 DE   HU   IT  
    Global end of trial date
    15 Jul 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 May 2021
    First version publication date
    29 May 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457A2324
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03504852
    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
    15 Jul 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy of secukinumab 300 mg every 2 weeks in comparison to secukinumab 300 mg every 4 weeks with respect to Psoriasis Area and Severity Index (PASI) 90 response at Week 16.
    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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Jun 2018
    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
    Canada: 37
    Country: Number of subjects enrolled
    Czechia: 16
    Country: Number of subjects enrolled
    Germany: 51
    Country: Number of subjects enrolled
    Hungary: 17
    Country: Number of subjects enrolled
    Italy: 19
    Country: Number of subjects enrolled
    Russian Federation: 30
    Country: Number of subjects enrolled
    United States: 161
    Worldwide total number of subjects
    331
    EEA total number of subjects
    103
    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)
    300
    From 65 to 84 years
    31
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 331 participants in the study were randomized and 330 participants were treated. (One participant in the AIN457 300mg Q4W (safety) arm was randomized but not treated. This participant was included in the randomization (demographic and disposition) set and the full analysis set, but was not included in the safety (Adverse Events) set.)

    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, Carer, Data analyst, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab 300 mg every 2 weeks (Q2W)
    Arm description
    		 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg solution for subcutaneous (sc) injection in a 1 mL prefilled syringe (PFS).

    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
    Placebo solution for sc injection in a 1 mL PFS matching the composition and appearance of secukinumab 150 mg dose

    Arm title
    		 Secukinumab 300 mg every 4 weeks (Q4W) (safety)
    Arm description
    		 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg solution for subcutaneous (sc) injection in a 1 mL prefilled syringe (PFS)

    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
    Placebo solution for sc injection in a 1 mL PFS matching the composition and appearance of secukinumab 150 mg dose

    Arm title
    		 Secukinumab 300 mg Q4W non-responders up-titration (Q4W NR up)
    Arm description
    		 2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).
    Arm type
    		 Active comparator

    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
    Placebo solution for sc injection in a 1 mL PFS matching the composition and appearance of secukinumab 150 mg dose

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg solution for subcutaneous (sc) injection in a 1 mL prefilled syringe (PFS)

    Number of subjects in period 1
    		Secukinumab 300 mg every 2 weeks (Q2W) Secukinumab 300 mg every 4 weeks (Q4W) (safety) Secukinumab 300 mg Q4W non-responders up-titration (Q4W NR up)
    Started
    165
    135
    31
    Completed
    148
    117
    28
    Not completed
    17
    18
    3
         Adverse event, serious fatal
    -
    1
    -
         Consent withdrawn by subject
    5
    5
    1
         Adverse event, non-fatal
    4
    8
    2
         Withdrawal of informed consent
    2
    1
    -
         Lost to follow-up
    4
    1
    -
         New therapy for study indication
    1
    -
    -
         Lack of efficacy
    1
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab 300 mg every 2 weeks (Q2W)
    Reporting group description
    		 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.

    Reporting group title
    Secukinumab 300 mg every 4 weeks (Q4W) (safety)
    Reporting group description
    		 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.

    Reporting group title
    Secukinumab 300 mg Q4W non-responders up-titration (Q4W NR up)
    Reporting group description
    		 2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).

    Reporting group values
    		 Secukinumab 300 mg every 2 weeks (Q2W) Secukinumab 300 mg every 4 weeks (Q4W) (safety) Secukinumab 300 mg Q4W non-responders up-titration (Q4W NR up) Total
    Number of subjects
    		 165 135 31 331
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 145 126 29 300
        From 65-84 years
    		 20 9 2 31
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.2 ± 12.73 46.1 ± 13.24 44.7 ± 13.61 -
    Sex: Female, Male
    Units: participants
        Female
    		 39 34 10 83
        Male
    		 126 101 21 248
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 1 0 2
        Asian
    		 4 4 1 9
        Native Hawaiian or Other Pacific Islander
    		 2 0 0 2
        Black or African American
    		 7 5 0 12
        White
    		 151 125 30 306
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
    Subject analysis sets

    Subject analysis set title
    Secukinumab 300 mg every 2 weeks (Q2W)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.

    Subject analysis set title
    Secukinumab 300 mg Q4W (up to week 16 pre-dose)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received 2 injections of secukinumab 150 mg once weekly for four weeks (at Randomization, Weeks 1, 2 and 3), followed by 2 injections of secukinumab 150 mg every four weeks, starting at Week 4 and up to Week 12.

    Subject analysis set title
    Secukinumab 300 mg Q4W (safety)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.

    Subject analysis set title
    Secukinumab 300 mg Q4W (efficacy)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes subjects randomized to remain on Q4W the entire treatment period, regardless of Psoriasis Area and Severity Index (PASI) 90 response status at Week 16.

    Subject analysis set title
    Secukinumab 300 mg Q4W non-responders up-titration (Q4W NR up)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).

    Subject analysis sets values
    		 Secukinumab 300 mg every 2 weeks (Q2W) Secukinumab 300 mg Q4W (up to week 16 pre-dose) Secukinumab 300 mg Q4W (safety) Secukinumab 300 mg Q4W (efficacy) Secukinumab 300 mg Q4W non-responders up-titration (Q4W NR up)
    Number of subjects
    165
    166
    135
    83
    31
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    92 ±
    ±
    ±
    ±
    Sex: Female, Male
    Units: participants
        Female
        Male
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
        Asian
        Native Hawaiian or Other Pacific Islander
        Black or African American
        White
        More than one race
        Unknown or Not Reported

    End points

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    End points reporting groups
    Reporting group title
    Secukinumab 300 mg every 2 weeks (Q2W)
    Reporting group description
    		 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.

    Reporting group title
    Secukinumab 300 mg every 4 weeks (Q4W) (safety)
    Reporting group description
    		 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.

    Reporting group title
    Secukinumab 300 mg Q4W non-responders up-titration (Q4W NR up)
    Reporting group description
    		 2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).

    Subject analysis set title
    Secukinumab 300 mg every 2 weeks (Q2W)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.

    Subject analysis set title
    Secukinumab 300 mg Q4W (up to week 16 pre-dose)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received 2 injections of secukinumab 150 mg once weekly for four weeks (at Randomization, Weeks 1, 2 and 3), followed by 2 injections of secukinumab 150 mg every four weeks, starting at Week 4 and up to Week 12.

    Subject analysis set title
    Secukinumab 300 mg Q4W (safety)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.

    Subject analysis set title
    Secukinumab 300 mg Q4W (efficacy)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes subjects randomized to remain on Q4W the entire treatment period, regardless of Psoriasis Area and Severity Index (PASI) 90 response status at Week 16.

    Subject analysis set title
    Secukinumab 300 mg Q4W non-responders up-titration (Q4W NR up)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).

    Primary: Number of subjects who achieve 90% or greater reduction in Psoriasis Area and Severity Index (PASI) score – week 16 (Full analysis set)

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    End point title
    		 Number of subjects who achieve 90% or greater reduction in Psoriasis Area and Severity Index (PASI) score – week 16 (Full analysis set)
    End point description
    A subject was considered as a PASI 90 responder if s/he achieved a reduction of 90% or more of the PASI score, compared to baseline, at a given time point.The head, trunk, upper limbs and lower limbs were assessed separately for erythema, thickening, and scaling. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, i.e., higher scores represent more severity.
    End point type
    Primary
    End point timeframe
    16 weeks
    End point values
    		 Secukinumab 300 mg every 2 weeks (Q2W) Secukinumab 300 mg Q4W (up to week 16 pre-dose)
    Number of subjects analysed
    165
    166
    Units: Participants
    121
    92
    Statistical analysis title
    		 Analysis of PASI 90 response at Week 16
    Comparison groups
    Secukinumab 300 mg every 2 weeks (Q2W) v Secukinumab 300 mg Q4W (up to week 16 pre-dose)
    Number of subjects included in analysis
    331
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0003 [1]
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    17.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.45
         upper limit
    		 27.98
    Notes
    [1] - One-sided p-value
    Statistical analysis title
    		 Analysis of PASI 90 response at Week 16
    Comparison groups
    Secukinumab 300 mg every 2 weeks (Q2W) v Secukinumab 300 mg Q4W (up to week 16 pre-dose)
    Number of subjects included in analysis
    331
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0003 [2]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.44
         upper limit
    		 3.78
    Notes
    [2] - One-sided p-value

    Secondary: Number of subjects who achieve Investigator Global Assessment (IGA modified 2011) score of 0 or 1 - week 16 (Full analysis set)

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    End point title
    		 Number of subjects who achieve Investigator Global Assessment (IGA modified 2011) score of 0 or 1 - week 16 (Full analysis set)
    End point description
    IGA mod 2011 was conducted for overall psoriatic disease. The IGA modified 2011 used in this study was static, i.e., it referred exclusively to the subject’s disease state at the time of the assessments, and did not attempt a comparison with any of the subject’s previous disease states, whether at baseline or at a previous visit. The scale has 0 (clear) as min and 4 (severe) as max, i.e., a higher score indicates more severity.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Secukinumab 300 mg every 2 weeks (Q2W) Secukinumab 300 mg Q4W (up to week 16 pre-dose)
    Number of subjects analysed
    165
    166
    Units: Participants
    122
    109
    Statistical analysis title
    		 Analysis of PASI 90 response at Week 16
    Comparison groups
    Secukinumab 300 mg every 2 weeks (Q2W) v Secukinumab 300 mg Q4W (up to week 16 pre-dose)
    Number of subjects included in analysis
    331
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0498 [3]
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    8.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.65
         upper limit
    		 18.2
    Notes
    [3] - One-sided p-value
    Statistical analysis title
    		 Analysis of PASI 90 response at Week 16
    Comparison groups
    Secukinumab 300 mg every 2 weeks (Q2W) v Secukinumab 300 mg Q4W (up to week 16 pre-dose)
    Number of subjects included in analysis
    331
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0498 [4]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 2.47
    Notes
    [4] - One-sided p-value

    Secondary: Absolute and relative frequencies for deaths, other serious or clinically significant adverse events or related discontinuations - Entire Study Period (Safety set)

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    End point title
    		 Absolute and relative frequencies for deaths, other serious or clinically significant adverse events or related discontinuations - Entire Study Period (Safety set)
    End point description
    An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
    End point type
    Secondary
    End point timeframe
    Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
    End point values
    		 Secukinumab 300 mg every 2 weeks (Q2W) Secukinumab 300 mg every 4 weeks (Q4W) (safety) Secukinumab 300 mg Q4W non-responders up-titration (Q4W NR up)
    Number of subjects analysed
    165
    134
    31
    Units: Participants
        Participants with any AE(s)
    127
    97
    24
        Participants with SAE of Death
    0
    1
    0
        Participants with Non-fatal SAE(s)
    14
    17
    4
        Participants who disc. study treatment due to AE
    4
    9
    2
    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 plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Secukinumab 300 mg every 2 weeks (Q2W)
    Reporting group description
    		 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.

    Reporting group title
    Secukinumab 300 mg Q4W (safety)
    Reporting group description
    		 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.

    Reporting group title
    Secukinumab 300 mg Q$W non-responders up-titration (Q4W NR up)
    Reporting group description
    		 2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).

    Reporting group title
    All Patients
    Reporting group description
    		 All Patients

    Serious adverse events
    		 Secukinumab 300 mg every 2 weeks (Q2W) Secukinumab 300 mg Q4W (safety) Secukinumab 300 mg Q$W non-responders up-titration (Q4W NR up) All Patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 165 (8.48%)
    18 / 134 (13.43%)
    4 / 31 (12.90%)
    36 / 330 (10.91%)
         number of deaths (all causes)
    0
    1
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Peripheral ischaemia
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 165 (1.21%)
    0 / 134 (0.00%)
    0 / 31 (0.00%)
    2 / 330 (0.61%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 165 (0.61%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    2 / 330 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 134 (0.00%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 134 (0.00%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lipase increased
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Blast injury
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 134 (0.00%)
    1 / 31 (3.23%)
    2 / 330 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 134 (0.00%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 134 (0.00%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 134 (0.00%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Atrial fibrillation
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    1 / 31 (3.23%)
    2 / 330 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Diastolic dysfunction
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 134 (0.00%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    1 / 31 (3.23%)
    2 / 330 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Quadriplegia
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tinnitus
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 165 (0.00%)
    0 / 134 (0.00%)
    1 / 31 (3.23%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal mass
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia, obstructive
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    0 / 165 (0.00%)
    0 / 134 (0.00%)
    1 / 31 (3.23%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholestatic liver injury
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 134 (0.00%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 134 (0.00%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibromyalgia
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 134 (0.00%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 134 (0.00%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acute HIV infection
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cellulitis
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 134 (0.00%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 165 (0.00%)
    0 / 134 (0.00%)
    1 / 31 (3.23%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 165 (0.00%)
    2 / 134 (1.49%)
    0 / 31 (0.00%)
    2 / 330 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 165 (0.00%)
    0 / 134 (0.00%)
    1 / 31 (3.23%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 134 (0.00%)
    0 / 31 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         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
    		 Secukinumab 300 mg every 2 weeks (Q2W) Secukinumab 300 mg Q4W (safety) Secukinumab 300 mg Q$W non-responders up-titration (Q4W NR up) All Patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 165 (40.00%)
    57 / 134 (42.54%)
    16 / 31 (51.61%)
    139 / 330 (42.12%)
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 165 (0.61%)
    3 / 134 (2.24%)
    3 / 31 (9.68%)
    7 / 330 (2.12%)
         occurrences all number
    1
    3
    4
    8
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 134 (0.75%)
    2 / 31 (6.45%)
    3 / 330 (0.91%)
         occurrences all number
    0
    1
    2
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 165 (6.67%)
    6 / 134 (4.48%)
    1 / 31 (3.23%)
    18 / 330 (5.45%)
         occurrences all number
    13
    6
    1
    20
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 165 (2.42%)
    3 / 134 (2.24%)
    2 / 31 (6.45%)
    9 / 330 (2.73%)
         occurrences all number
    4
    3
    2
    9
    Pyrexia
         subjects affected / exposed
    2 / 165 (1.21%)
    2 / 134 (1.49%)
    2 / 31 (6.45%)
    6 / 330 (1.82%)
         occurrences all number
    2
    3
    3
    8
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 165 (6.06%)
    6 / 134 (4.48%)
    2 / 31 (6.45%)
    18 / 330 (5.45%)
         occurrences all number
    12
    8
    2
    22
    Nausea
         subjects affected / exposed
    1 / 165 (0.61%)
    4 / 134 (2.99%)
    2 / 31 (6.45%)
    7 / 330 (2.12%)
         occurrences all number
    1
    5
    2
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 165 (4.24%)
    2 / 134 (1.49%)
    2 / 31 (6.45%)
    11 / 330 (3.33%)
         occurrences all number
    8
    2
    3
    13
    Oropharyngeal pain
         subjects affected / exposed
    3 / 165 (1.82%)
    7 / 134 (5.22%)
    2 / 31 (6.45%)
    12 / 330 (3.64%)
         occurrences all number
    3
    7
    2
    12
    Skin and subcutaneous tissue disorders
    Intertrigo
         subjects affected / exposed
    4 / 165 (2.42%)
    0 / 134 (0.00%)
    3 / 31 (9.68%)
    7 / 330 (2.12%)
         occurrences all number
    4
    0
    3
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 165 (4.24%)
    6 / 134 (4.48%)
    2 / 31 (6.45%)
    15 / 330 (4.55%)
         occurrences all number
    8
    6
    2
    16
    Back pain
         subjects affected / exposed
    3 / 165 (1.82%)
    6 / 134 (4.48%)
    2 / 31 (6.45%)
    11 / 330 (3.33%)
         occurrences all number
    3
    7
    2
    12
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    32 / 165 (19.39%)
    22 / 134 (16.42%)
    5 / 31 (16.13%)
    59 / 330 (17.88%)
         occurrences all number
    46
    27
    7
    80
    Tooth abscess
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 134 (0.00%)
    2 / 31 (6.45%)
    3 / 330 (0.91%)
         occurrences all number
    1
    0
    2
    3
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 165 (7.27%)
    9 / 134 (6.72%)
    3 / 31 (9.68%)
    24 / 330 (7.27%)
         occurrences all number
    15
    11
    4
    30
    Urinary tract infection
         subjects affected / exposed
    1 / 165 (0.61%)
    5 / 134 (3.73%)
    2 / 31 (6.45%)
    8 / 330 (2.42%)
         occurrences all number
    1
    6
    2
    9
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    3 / 165 (1.82%)
    0 / 134 (0.00%)
    2 / 31 (6.45%)
    5 / 330 (1.52%)
         occurrences all number
    3
    0
    2
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    08 Feb 2019
    The study was temporarily interrupted because of insufficient drug supply. New supply was released in the US on 06 March 2019 and in Canada and Russia on 07 Mar 2019.
    06 Mar 2019

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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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